mteb/BIRCO-ClinicalTrial-Test huggingface dataset:
The specific goal of this research study is to investigate the feasibility, acceptability, and preliminary efficacy of a transdiagnostic, cognitive-behavioral therapy developed specifically to target common core processes across mood and anxiety disorders [Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)], for the treatment of patients with bipolar I disorder (BD-I) and comorbid anxiety. The study will compare treatment-as-usual with pharmacotherapy (TAU) plus 18 one-hour sessions of treatment with the UP to TAU alone. Patients in both treatment conditions will be followed over a 12-month period and will be assessed monthly to track changes in mood, anxiety and emotion-related symptoms; functional impairment; and relapse rates. Data on the acceptability of the treatment will be gathered concurrently through monthly patient self-reported ratings of treatment satisfaction, and by tracking rates of acceptance for randomization into the study, number of completed sessions, and dropout rates. The study will examine: 1) whether combined cognitive behavioral treatment (UP) for BD-I and comorbid anxiety disorders is an acceptable and feasible approach to treatment; 2) whether treatment with the UP for BD-I and comorbid anxiety disorders as an adjunct to pharmacotherapy treatment-as-usual (TAU) leads to greater symptom reduction and reduced functional impairment than pharmacotherapy alone, 3) whether treatment for BD-I and comorbid anxiety disorders with the UP improves relapse rates over a 6-month follow-up relative to TAU; and 4) whether reduction in symptoms, relapse rates, and functional impairment are mediated by changes in emotion regulation skills.
Background: Bipolar disorder is one of the most common mental illnesses affecting 1%-4% of the population, and one of the leading causes of worldwide disability. Mania is a condition of excessively elevated mood, characterizes bipolar disorder, and usually is a main cause of hospitalization. Mood stabilisers and antipsychotic drugs have long been the maintenance treatment of acute mania with and without psychotic symptoms. Though clinical trails have been demonstrated that these drugs are individually more effective than placebo in the relatively long term (e.g 4, 8 weeks). However, in the pragmatic practice, patient at acute mania urgently want to see the effectiveness, and psychiatrist under great pressure and are in great need to evaluate the very short-term effectiveness (e.g one week). If the first attempted antimanic drug fails, psychiatrist need the evidence that which medication should be to added on or switch to. Objectives: one main aim is to rank the short-term ( e.g.one and two week) effectiveness and acceptability of the common anti-mania drugs, including Lithium, Valproate, Oxcarbazepine, Quetiapine, Olanzapine, or Ziprasidone. Secondary aim is to investigate which medication to add on for non-responders or switch to. Methods: The study setting: it is expected that 120 subjects with a diagnose of DSM-IV bipolar I disorder will be recruited from Guangzhou Psychiatric Hospital, the earliest psychiatric hospital in the history of China established by Dr.J.
The purpose of this study is to evaluate the efficacy and safety of sublingual zolpidem presentation 5 mg in the induction of sleep in patients with primary insomnia. - National study, phase IV, single-center, double-blind, randomized, parallel, controlled by zolpidem 10mg oral. - Experiment duration: 93 days. - 05 visits (days -3, 0, 15, 45 and 90). - Efficacy will be evaluated for: Sleep induction and the maintenance of sleep. - Adverse events evaluation.
Observational evidence and findings from clinical trials conducted for other reasons suggest that lithium, a drug used for the treatment of bipolar disorder, and, to a lesser extent, depression, may reduce rates of suicides and suicide attempts. However, this hypothesis has not yet been adequately examined in a randomized clinical trial conducted specifically to test lithium's efficacy in preventing suicides. This clinical trial fills this gap. This study is feasible within the Department of Veterans Affairs (VA) because it is a large, integrated health system with existing programs for identifying patients at risk for suicide and delivering enhanced services. In VA, approximately 12,000 patients with depression or bipolar disorder survive a suicide attempt or related behavior each year, and 15% of them repeat within one year. Experimental treatment in this study will supplement usual care for major depression or bipolar disorder, as well as VA's standard, enhanced management for patients at high risk. The investigators will recruit 1862 study participants, from approximately 30 VA Hospitals. Participants will be patients with bipolar disorder or depression who have survived a recent episode of suicidal self-directed violence or were hospitalized specifically to prevent suicide. Randomly, half will receive lithium, and half will receive placebo. Neither the patients nor their doctors will know whether a particular person has received lithium or placebo. The treatment will be administered and the patients will be followed for one year, after which patients will go back to usual care.
This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from bipolar depression. The first drug, Ketamine, is an experimental antidepressant that early studies have shown may quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the comparison drug, is not thought to reduce depression or suicidal thoughts. Patients currently taking psychiatric medications may continue them during the study. However, if a patient is taking a benzodiazepine (such as Ativan, Klonopin, or Xanax), they will be able to take up to 2mg per day of Lorazepam during the week before the infusion, but none will be permitted in the 24 hours pre-infusion. Also, Zolpidem (Ambien) will not be permitted in the 24 hours pre-infusion. If a person chooses to participate, their dose of benzodiazepine may need to be reduced so that they can do without it during the 24 hours pre-infusion. Participants are randomly assigned to receive a single dose of ketamine (0.5 mg/kg) or Midazolam (0.02 mg/kg), which is given slowly, in a vein, over about 40 minutes. The study is "double-blind," meaning patients and study staff will not know which medication is in the infusion. If a patient does not respond to the first infusion, and s/he received Midazolam, then s/he will be offered the option of a second infusion, this time with Ketamine (0.5 mg/kg).
The main aim of this study is to test a new, non-medication computer-based potential treatment for bipolar disorder in children and adolescents. In the study, children and adolescents with bipolar disorder will come to our lab at Bradley Hospital 2-times per week for 8-weeks to "play" a custom computer "game" designed to retrain the brain--to build a skill that my work has shown is impaired in children/adolescents with bipolar disorder. Before and after this 8-week trial, children will have a special magnetic resonance imaging (MRI) scan. This is a test of feasibility--meaning we want to see if the 8-week trial results in brain changes. If it does, we will conduct a second study to see if it improves how bipolar children function--i.e., if it helps their illness. Prior studies have shown that "computer assisted cognitive remediation"--meaning using computer "games" to build up a skill that has been shown to be impaired in a specific disorder--can result in improvement in psychiatric illnesses--including schizophrenia. This will be the first National Institute of Mental Health (NIMH)-funded study to use this "retrain your brain" approach in children and adolescents with bipolar disorder. During this study, we are seeking 40 children and adolescents with bipolar disorder to: - come to our lab at Bradley Hospital in East Providence R.I. twice per week (each lasting 1 hour) to "play" a special computer game for a total of 8 weeks - to have a special MRI before and after this 8-week trial to see if our "game" improves brain activity - it does NOT matter if your child is already on medications--they can continue during this study - all children/adolescents with bipolar disorder are welcome--as long as they do NOT have implanted metal (no braces, no cochlear implants, etc) because of magnetic resonance imaging (MRI) safety.
Of all psychiatric diagnoses, bipolar disorder imparts the greatest risk for completed suicide in adolescence, and is further associated with poor psychosocial functioning, substance abuse and legal difficulties, and exorbitant healthcare costs exceeding those for other adolescent psychiatric conditions. Treatment guidelines indicate optimal management of pediatric bipolar disorder includes a combination of medication and psychotherapy. Yet, little is known about effective psychotherapy approaches for this population, and none expressly target suicidality. An efficacious, cost-effective psychosocial intervention for adolescents with bipolar disorder has great potential to decrease the substantial morbidity, mortality and costs associated with adolescent bipolar disorder. Of all psychiatric diagnoses, bipolar disorder (BP) imparts the greatest risk for completed suicide in adolescence, and is associated with other negative outcomes including poor psychosocial functioning and substance abuse. Furthermore, healthcare costs for adolescents with BP exceed those for other adolescent psychiatric conditions. Treatment guidelines indicate optimal management of pediatric BP includes a combination of pharmacotherapy and psychotherapy. Yet, little is known about effective psychotherapy approaches for this population, and none expressly target suicidality. An efficacious, cost-effective psychotherapy for adolescents with BP has great potential to decrease the substantial morbidity, mortality and costs associated with this illness. Dialectical Behavior Therapy (DBT) is a skills-based psychotherapy originally developed for adults with borderline personality disorder. DBT holds promise for adolescents with BP given shared treatment targets including suicidality and psychosocial functioning.
Suicide attempters or people with self-harm have a high percentage in seeking medical services before and after their suicidal or self-harm behaviour compared to general population. Studies revealed that apart from psychiatric services, they were more likely to seek help from doctors of various units (e.g. emergency departments, general medicine, medical-surgical units) across different healthcare systems (i.e. hospitals or district clinics). Besides, suicide event was possibly heard on in-patients of psychiatric or non-psychiatric units. People with self-harm experienced poor communication with healthcare personnel, and they perceived staff's lacking knowledge about suicide as serious problems. In Taiwan it was also found that emergency nurses and general practitioners were in need of improving negative attitudes and enhancing knowledge towards suicidal behaviour. From the point that nurses are the healthcare personnel that spend the most time with in-patients compared to others in the hospital, suicide risk assessment training may enhance nurses' attitudes and ability of risk awareness and assessment towards people with self-harm, which may in turn significantly increase the identification rate of the high risk group for suicide. Currently there is a lack of suicide training program as a reference for nursing education in Taiwan. The study therefore aims to strengthen suicide risk assessment ability among clinical nurses through interactive discussion groups. Using quasi-experimental design with randomized cluster sampling strategy, a case vignettes will be used for suicide risk assessment together with other measurements regarding suicide knowledge and attitudes for both experiment and control groups before and after the training course.
The primary hypothesis of this confirmatory study is that lithium therapy will acutely decrease suicidal ideation and/or suicidal behaviour in inpatients with a major depressive episode (MDE, unipolar and bipolar disorder according to DSM IV criteria). The specific aim is to test the hypothesis that lithium plus treatment as usual (TAU), compared to placebo plus TAU, results in a significantly greater decrease in suicidal ideation and/or behaviour over 5 weeks in inpatients with MDE. The study will consist of 254 adult patients, hospitalized for a major depressive episode with suicidal ideation and/or behaviour who will be randomized to two groups of each 127 participants. All study participants will receive treatment as usual in the hospital, including (psycho)pharmacological treatment and, if needed, psychotherapy plus a 5-week course of lithium or placebo. Rating scales will be used daily resp. weekly to measure suicidal ideation and/or behaviour, depression, anxiety, mixed/manic features and impulsiveness. Experienced clinicians will rate suicidal ideation and/or behaviour as well as depression twice a week and anxiety, mixed/manic features and impulsiveness once a week.
Children who have parents with bipolar disorder are at risk for developing anxiety disorders. Typical treatments for anxiety in children are SSRI antidepressants. However, these medications may accelerate the onset of mania or hypomania in children with a family history of bipolar disorder or cause suicidal thinking in children. Studies trying alternative treatments to anxiety and possible bipolar disorder in children are needed, to establish other methods for treating childhood mental health. These studies can also help with early intervention and possible future prevention strategies for bipolar disorder. This study involves treating anxious children with Mindfulness Based Cognitive Therapy. They will have 12 weeks of mindfulness therapy in a group with other children where they will be led by a trained group leader, how to pay attention to anxiety cues and react differently.
The purpose of this investigator-initiated study is to compare the efficacy of oral midazolam and zolpidem for preoperative sedation, anxiety of patient, and caregiver anxiety at the time of separation, and ease of mask acceptance at induction in children. Subjects will be randomized to receive oral medication midazolam or zolpidem approximately 30 minutes prior to surgery. No placebo will be administered in this study. Subjects will be male and female children between 2 and 9 years of age. In total, subject participation will last approximately the duration of their preoperative, perioperative, and immediate postoperative period. A member of the research team will recruit subjects preoperatively in the operating room holding area prior to surgery. Consent will take place at the time of recruitment in the preoperative holding area following a detailed explanation of the study and medications involved in the study. Participants will be of ASA (American Society of Anesthesiologists) class I-II, undergoing surgical procedures of at least 2 hours duration, and expected to remain inpatient for at least 23 hours postoperatively.
The main objective of this study is to evaluate decision-making using the Iowa Gambling Task (IGT) among patients with euthymic bipolar disorder according to their personal history of suicide attempt ("suicidal" vs. "not suicidal "). The secondary objectives of this study are: A. Evaluate other aspects of cognitive functioning (using the Tower of London, the Probabilistic Reversal-learning task, the Rey Complex Figure, the Reading the Mind in the Eyes test) in euthymic patients with bipolar disorder, depending on the presence or absence of a history of suicide attempt; B. Explore performance on neuropsychological tests depending on the type of therapy administered (lithium salts or valproate monotherapy or in combination with other mood stabilizers); C. Explore a possible relationship between circulating levels of lithium or sodium divalproex results and different neuropsychological tests; D. Establishment of a biobank for this population with leftover blood samples following serum lithium or divalproex testing.
Children and adolescents with early-onset bipolar disorder (BD) are at high risk for intentionally hurting themselves. Although there are therapies in existence for these youths with BD, they do not address suicide prevention specifically. Mentalization-based therapy for adolescents (MBT-A) has been shown to be helpful in reducing self-harm in the adolescent and adult population with borderline personality disorder. The investigators will modify the MBT-A treatment procedures for persons with BD who have had a recent period of suicidal ideation or behavior. Youth with early-onset bipolar disorder (BD) are at an elevated risk for intentional self-harm compared to healthy adolescents or adolescents with other psychiatric disorders. Adolescents vulnerable to emotion dysregulation and self-harm often have deficits in the ability to mentalize: to understand, acknowledge, and predict thoughts and feelings in oneself and others. Mentalization-based therapy for adolescents (MBT-A) has been shown to be more effective than 'usual care' in reducing self-harm for adolescents and adults with borderline personality disorder. MBT-A includes psychoeducational and coping strategies that may prove quite effective for bipolar adolescents who are at elevated risk for self-harm. Participation in this study will last 9 months. All participants will receive a thorough medical-psychiatric evaluation. All youth will be able to receive pharmacotherapy with a study psychiatrist in the CHAMP clinic. The MBT-A will consist of up to 21 weekly, biweekly and monthly individual sessions interspersed with 9 monthly family sessions (30 therapy hours total).
The purpose of this study is to evaluate whether drug efficiency of zolpidem and amitriptyline can be conditioned according to learning theory in patients with primary insomnia. Previous research has shown that repeated drug treatments can be regarded as conditioning processes. Sleep disorders are especially of interest to be investigated under the perspective of conditioning with drugs, since sleep quality can be defined both in terms of subjective ratings (self-rated sleep quality parameters) and objective measures (via polysomnographic assessment PSG; e.g., total sleep time, sleep onset, sleep architecture). By using two different drugs (zolpidem, amitriptyline) that modulate sleep differentially, the investigators intend to implement a conditioning paradigm in sleep disorders dissociating conditioning effects on subjective and objective sleep parameters. Both drugs should affect objective and subjective sleep parameters positively, while only amitriptyline should modulate the objectively assessed sleep architecture by REM-suppression (latency of REM-sleep onset, percentage of REM-sleep).Patients with mild to moderate insomnia will undergo a classical conditioning paradigm with one of two study medications: amitriptyline or zolpidem. After an acquisition period and a wash-out period, conditioned sleep changes are assessed in an evocation trial. During a second treatment phase of 7 days, patients receive different doses of amitriptyline (between 0mg and 50mg per night) or zolpidem (between 0mg and 5mg per night) to evaluate alternative dosing regimens in the pharmacotherapy of mild to moderate Insomnia.
Major depressive disorder (MDD) occurs at least 11% of adolescents and approximately 53-90% of those adolescents have insomnia. If left untreated, insomnia increases the risk of relapse and recurrence of depressive episodes, unintentional injuries, poor school performance, substance use, obesity, and the risk for suicide. This project seeks to develop a nonpharmacological treatment for insomnia in adolescents with depression that is feasible and effective. The specific methodologies that will help accomplish these results are: 1) use of focus groups of adolescents with depression and insomnia to determine how the current standard, nonpharmacological treatment for insomnia (cognitive-behavioral therapy for insomnia; CBTI) among adults can be modified for use by adolescents with depression and 2) determine the preliminary effectiveness, feasibility, and tolerability of group CBTI in adolescents with depression (CBTI-AD) developed using feedback from the focus groups. This project will help to improve the quality and scope of delivery of mental health services in Michigan by a) gaining a greater understanding of how sleep disturbance may perpetuate depression in adolescents and b) to provide mental health professionals with a nonpharmacological treatment option for insomnia in adolescents with depression.
Laboratory testing has suggested that lithium may decrease the incidence of certain types of cancer, including prostate cancer. Additional research has suggested that lithium decreases prostate cancer tumor size over time. This study will investigate the effect of lithium on men with prostate cancer. As lithium has been shown in an in vitro model to suppress cellular proliferation, and suppress tumor growth in an in vivo xenograft model, we propose to determine its effect on prostate cancer cells in human patients undergoing radical prostatectomy. In this pilot study we plan to assess the toxicity of lithium administration in patients prior to radical prostatectomy. This will include any clinical toxicity as well as any increase in intra-, peri- or postoperative complications.
Schizophrenia and bipolar disorders are major public health problems. The second generation anti-psychotic drugs have efficacy for both positive and negative symptoms and a favorable risk profile as far as movement disorders. However, these drugs are associated with clinically significant weight gain and metabolic effects. The underlying mechanisms of these side effects are unclear, however in our preliminary studies with schizophrenic patients on atypical anti-psychotic drugs, we found that weight gain and vitamin D deficiency was present in about 50% of this population. Given the considerable heterogeneity among the patients on atypical anti-psychotics and potential for weight gain in vitamin D-deficient states, we propose that patients with schizophrenia who gain weight on atypical antipsychotic medications are vitamin D-deficient. This hypothesis will be tested in patients with schizophrenia receiving second-generation anti-psychotic drugs for a minimum duration of 4 months. Specific Aim: We predict that the patients with schizophrenia, who gain weight with antipsychotic treatment, are vitamin D-deficient compared to the patients who do not gain weight. We will examine circulating levels of serum 25(OH)D, mRNA transcripts and protein expression of vitamin D receptor (VDR) and the enzymes, CYP24A and CYP27B, in the white blood cells of the subjects and correlate with BMI and the blood levels of leptin and adiponectin. Specific Aim: We predict that the patients with schizophrenia, who gain weight with antipsychotic treatment, are vitamin D-deficient compared to the patients who do not gain weight.
Determine the efficacy and tolerability of olanzapine for treatment of acute depression in patients with bipolar II or bipolar disorder NOS compared with lithium.
The investigators propose to explore the link between bipolar disorder, anxiety, and suicide by investigating intertemporal discounting in depressed, suicidal patients with bipolar I and II disorder who have various levels of anxiety. The investigators will determine the effect of anxiety on their intertemporal discounting (small rewards now compared to larger rewards later) in a decision-making paradigm and investigate the associated functional neuroanatomy using functional magnetic resonance imaging (fMRI). Among the various psychological properties of the decision making process is temporal discounting, which is a decrease in the subjective value of a good as a function of the amount of and delay to reward. The ability to decide between immediate versus future rewards depends on self-control and consideration of the future. We can reconceptualize suicide as intertemporal discounting with an interaction between cognition and mood. Someone contemplating suicide weighs the time value of costs and benefits with shifting negative and positive valence systems. To the best of our knowledge, no one has assessed the interaction between mood symptoms, anxiety, and their impact on the temporal discounting paradigm in bipolar patients. If we better understood the difference between anxious, suicidal and non-anxious, suicidal bipolar patients, we could design more effective interventions to prevent this tragic outcome. We propose a novel paradigm to explore the link between bipolar disorder, anxiety, and suicide. If we conceptualize suicidal behavior and death by suicide as decisions, then it makes sense to examine key aspects of decision making in these patients.
This is a Phase IV, randomized, double-blind, placebo-controlled, four-arm crossover study. The study will assess the effects of a single dose of Silenor 6 mg compared with matching placebo and a single dose of zolpidem 10 mg compared to its matching placebo at the respective T-max in normal healthy adult male volunteers. The study will be conducted in approximately 52 male subjects Subjects will be screened and asked to complete sleep disorders questionnaires and a sleep diary to establish normal sleep patterns and to rule out any sleep disorder. Eligible subjects will be scheduled for a Screening PSG to rule out PLMS, sleep apnea and other sleep disorders. Subjects who meet the screening PSG criteria will be randomly assigned to a treatment sequence order that involves both the study drug and the time subjects are awakened in the middle-of-the-night using a crossover study design. These four sequences include Silenor 6 mg with a middle-of-the-night awakening at 4 hours (DXP-4H), zolpidem 10 mg with a middle-of-the-night awakening at 1.5 hours (ZOL-1.5H), placebo with a middle-of-the-night awakening at 4 hours (PBO-4H), and placebo with a middle-of-the-night awakening at 1.5 hours (PBO-1.5H). Study drug will be administered under fasted conditions (at least 4 hours) as a single dose at bedtime (approximately 2300 hours), and each subject will receive one dose of each active drug (Silenor 6 mg and zolpidem 10 mg), and two doses of placebo during the treatment period.
50 patients of clinical, radiological, biopsy proven cirrhosis patient will be randomized into cases and control groups after ruling out possibility of psychiatric illnesses like depression and anxiety with the help of questionnaires. After ruling out psychiatric disorders patient will be enrolled according to Epworth sleeping scale, Pittsburgh sleep quality index and insomnia severity score followed by polysomnography. After fulfilling all inclusion criterias patients in cases group (Group 1) will receive zolpidem 5mg at bed time daily and patients in control group will receive placebo at bed time daily. The treatment will be continued for 4 weeks. All patients will be advised regarding sleep hygiene.
Lithium, the gold standard for treatment of Bipolar Disorder (BD) and a common augmentation to medication therapy for Major Depression, is commonly continued in pregnancy due to its therapeutic benefit and more recent data that suggests the teratogenic effects of lithium are less than historically believed. Due to the increased elimination of lithium during pregnancy, lithium concentration decreases in the blood and women with BD are vulnerable to BD episode recurrence in pregnancy. Uncontrolled symptoms of BD in pregnancy increase the risk for postpartum exacerbation of BD and psychosis. Our study will investigate the pharmacokinetics (PK) of lithium prior to pregnancy, during pregnancy, and postpartum. Twenty women taking lithium in pregnancy or planning to become pregnant and continue lithium will be invited to participate in a study to measure repeated blood levels of lithium at six time points between preconception and 3 months postpartum. The data collected will inform the dose, timing of dose, and frequency of dosing of lithium that will lead to fewer untoward effects for the mother and baby. Change in elimination clearance of lithium will be correlated with symptom worsening to develop a dosing algorithm that will help maintain wellness for pregnant women with mood disorders. There is an increased risk of recurrence of Bipolar Disorder (BD) episodes or worsening symptoms in pregnancy after the discontinuation of mood stabilizers. Similarly, changes in medication concentration due to the physiological changes in pregnancy may effectively reduce the medication dose and thus its efficacy in pregnancy.
This Study will evaluate the impact of a smartphone-based platform on a range of outcomes for medically-underserved patients with mood disorders (e.g. depression, anxiety, bipolar) cared for in a large statewide community health center. The primary goal of the Study is to reduce emergency room (ER) visits, hospitalizations, and to look at changes in service utilization by using the Ginger.io platform to enhance communication between behavioral health providers and their patients, increasing the early detection of exacerbations in mood disorders (e.g. depression, anxiety, bipolar) and proactive outreach. The secondary goal is to improve clinical & behavioral health outcomes. Procedures involved in the Human Research Overview: The investigators will use a quasi-experimental study with a pre-post intervention design to evaluate the usability, feasibility, acceptability, and potential utility of a smartphone app to improve patient-behavioral health provider communication and care for patients with mood disorders (e.g. depression, anxiety, bipolar). The smartphone app will collect patient smartphone interaction data and survey data from patients on their health and functioning including mood, depression, and anxiety levels. At various points during the study, patients will be surveyed about their experience using the smartphone application, Ginger.io. All behavioral health providers at Community Health Center, Inc. (CHCI) who are using the app with their patients will be granted access to a secured, password-protected, web-based dashboard that will collect and display information related to patients' health and behavior.
Phase IV, multinational, multicentre, open-label, non-randomized, clinical trial conducted in Europe (Spain, Germany, Finland, Norway, Romania and Austria) to evaluate the safety profile of ADASUVE® in agitated patients with schizophrenia or bipolar disorder when self-administered outside of a hospital setting without the supervision of a healthcare professional. The Study will aim to include approximately 500 patients who have been previously treated with ADASUVE® in the last 6 months prior to screening or recently treated during the planned recruitment period of 6 months with a 'positive outcome' ('ADASUVE® responder') according to Clinical Global Impressions (CGI-I) scale, from a total of about 30-34 centers. All patients will be followed up for a maximum of 6 months from baseline, during which it is expected that a new episode of agitation will occur. OVERALL STUDY DESIGN: This is a phase IV, multinational, multicentre, open-label, non-randomized, clinical trial conducted in Europe (Spain, Germany, Finland, Norway, Romania and Austria) to evaluate the safety profile of ADASUVE® in agitated patients with schizophrenia or bipolar disorder when self-administered outside of a hospital setting without the supervision of a healthcare professional. The Study will aim to include approximately 500 patients who have been previously treated with ADASUVE® in the last 6 months prior to screening or recently treated during the planned recruitment period of 6 months with a 'positive outcome' ('ADASUVE® responder') according to Clinical Global Impressions (CGI-I) scale, from a total of about 30-34 centers.
The purpose of this study is to evaluate the efficacy of suvorexant, added to existing medications, for treatment-resistant insomnia in individuals with bipolar disorder. The investigators hypothesize that participants receiving suvorexant for one week will experience significantly greater improvement in sleep duration compared to participants receiving placebo. Participants will be randomized to receive double-blind suvorexant or placebo for one week, after which all participants will receive open treatment with suvorexant for three months.
Depression and suicidal ideation/attempt/death are major causes of morbidity and mortality from psychiatric illnesses. In 2009, the World Health Organization listed depression as the leading cause of years lost due to disability worldwide. Suicide is the 9th most common cause of death in Canada with 1.6% of Canadians ultimately dying from suicide (Statistics Canada, 2012) and the 2nd most common cause of death in young people after accidental deaths. This information highlights the importance of finding treatments to prevent suicidal deaths. Ketamine has been shown to provide rapid treatment response for major depressive episodes both in major depressive disorder (MDD) and bipolar disorder (BD), via a single intravenous infusion which persists for at least 72 hours. The purpose of this study is to conduct a pilot trial of IV ketamine + treatment as usual (TAU) vs. midazolam (an active placebo) + TAU to estimate sample size for a full-scale RCT examining these treatments for decreasing suicidal ideation among depressed inpatients with major depressive disorder and bipolar depression. A total of 52 patients will be recruited for this trial. All subjects will be inpatients at Sunnybrook Health Sciences Centre with a diagnosis of either major depressive disorder or bipolar disorder type I or II currently depressed. Suicidal ideation must be present at baseline assessment in order to be included in the study. Thirteen subjects will be randomized to each treatment arm in each treatment stream - that is, 13 will be recruited to ketamine + TAU in the major depressive disorder stream, and 13 will be recruited to the midazolam + TAU in the major depressive stream.
The purpose of this study is to learn the environmental and psychological factors that impact suicidality in African-American adults with Bipolar Disorder. Additionally, the study aims to identify treatments to reduce the suicidal behavior and improve quality of life through a 6-week group-based intervention program. The purpose of this study is to learn the environmental and psychological factors that impact suicidality in African-American adults with Bipolar Disorder. Additionally, the study aims to identify treatments to reduce the suicidal behavior and improve quality of life through a 6-week group-based intervention program.Groups will include topics such as social skills training, mindfulness interventions, as well as interventions focused on understanding and changing thoughts to better cope with Bipolar Depression.
This is a Phase I, open-label, randomized trial to evaluate the single-dose pharmacokinetics of Zolpidem orodispersible tablet at two different dosages (1.75 mg and 3.50 mg). Sample size is 48 participants, male or female, aged above 18 years-old. Primary objective is to evaluate pharmacokinetics of Zolpidem orodispersible tablet at two different dosages (1.75 mg and 3.50 mg), and secondary objective is to evaluate safety and tolerability of the investigational product. Participants will be admitted for a period of 36 hours, when investigational product will be administered, and blood samples, at pre-determined time periods, will be collected for pharmacokinetics. Primary endpoint is to obtain pharmacokinetics parameters. Additionally, safety will be assessed by adverse events occurrence and laboratory exams evaluation.
The purpose of this study is to see if it is safe and effective to give CPI-1189 to patients with AIDS dementia. Advanced HIV infection can cause AIDS dementia (brain damage due to HIV leading to loss of memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down. Late-stage HIV infection can cause AIDS dementia (brain damage due to HIV leading to loss of memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down. Patients are randomized to receive either placebo or one of two oral doses of CPI-1189 daily. Patients are assessed for safety and tolerability during Weeks 2, 6, and 10. At Week 10, efficacy assessments are also made. For those who volunteer, a sample of cerebrospinal fluid is obtained at baseline and at Week 10. Blood samples for CPI-1189 pharmacokinetic trough measurements are taken at Weeks 2 and 10. The open-label phase starts at Week 11. At Weeks 13 and 16, a safety evaluation is performed. At the end of the open-label phase, Week 22, a final set of safety and efficacy assessments and a blood sample for CPI-1189 pharmacokinetic trough measurement are obtained.
OBJECTIVES: I. Evaluate the effects of androgen suppression with leuprolide and androgen replacement with testosterone enanthate on muscle strength in men with Kennedy's disease or other motor neuron disease. PROTOCOL OUTLINE: All patients receive androgen suppression with leuprolide acetate injections every 4 weeks for 6 months, plus hormone replacement therapy with testosterone enanthate injections every week for 24 weeks.
This study will use high-resolution magnetic resonance imaging (MRI) to look for subtle differences in brain anatomy between patients with focal hand dystonia (also called writer s cramp) and healthy normal volunteers. Patients with hand dystonia have prolonged muscle contractions that cause sustained twisting movements and abnormal postures. These abnormal movements often occur with activities such as writing, typing, playing certain musical instruments such as guitar or piano, or playing golf or darts. Patients with focal hand dystonia and healthy volunteers will be enrolled in this study. Patients will be recruited from NINDS s database of patients with focal hand dystonia. Volunteers will be selected to match the patients in age, sex and handedness. This study involves two visits to the NIH Clinical Center. The first visit is a screening visit, in which patients and volunteers will have a medical history, physical examination, neurological examination, and assessment of handedness. Women of childbearing age will be screened with a pregnancy test. Pregnant women are exclude from this study. Those who join the study will return for a second visit for magnetic resonance imaging. MRI uses a magnetic field and radio waves to produce images of the brain. For the procedure, the participant lies still on a stretcher that is moved into the scanner (a narrow cylinder containing the magnet). Earplugs are worn to muffle loud noises caused by electrical switching of radio frequency circuits used in the scanning process.
This study has two purposes: 1) to understand the effect of a decline of dopamine in the brain during normal aging and in patients with Parkinson's disease, and 2) to investigate how medicines used to treat Parkinson's disease improve movement performance in patients. Patients with Parkinson's disease have difficulty performing precise finger movements, mainly because of a dramatic decrease of a substance called dopamine in parts of the brain. Medicines such as levodopa, which help restore dopamine levels, can greatly improve function; however, little is known about how these drugs work. In normal aging, dopamine decreases slightly in certain parts of the brain, but the importance of this decline is poorly understood. This study may provide new information about Parkinson's disease and normal aging that might lead to better treatment strategies. Patients with mild to moderate Parkinson's disease and healthy volunteers 21 years of age and older may be eligible for this study. All participants must be right-handed. All candidates will be screened with a medical history and physical and neurological examinations, including memory tests and mood examination. Brain function will be studied using functional magnetic resonance imaging (fMRI) study and positron emission tomography (PET). Participants may be asked to stop using medications that can affect the central nervous system, such as sleeping pills or drugs for depression or anxiety, for 1 week before each study visit.
This pilot study will evaluate the effect of direct current (DC) electrical polarization of the brain on language, memory, reaction time, and mood in six patients with frontotemporal dementia (Pick's disease). There is no effective treatment available for cognitive impairment in patients with this condition. DC polarization sends a very weak current between two sponge pads placed on the head. In a previous study in healthy volunteers, DC polarization of the left prefrontal area of the brain increased verbal fluency, memory and attention, and motor reaction time in the study subjects. Patients between 35 and 75 years of age with frontotemporal dementia who have been referred to NINDS's Cognitive Neuroscience Section for an existing protocol will be offered participation in this study. Candidates will be screened with a neurological examination to confirm the diagnosis of frontotemporal dementia. Participants receive 40 minutes of DC polarization or sham polarization in each of two separate sessions. (No current is applied in the sham treatment). During the polarization, the patient rests quietly. Sponge pads that have been soaked in water are put on the left side of the head and above the right eye, and are held in place with elastic netting. Before the polarization and after about 20 minutes of polarization, patients undergo the following tests: - Language: Patients must say as many words beginning with certain letters as they can in 90 seconds.
PRION-1 aims to assess the activity and safety of Quinacrine (Mepacrine hydrochloride) in human prion disease. It also aims to establish an appropriate framework for the clinical assessment of therapeutic options for human prion disease that can be refined or expanded in the future, as new agents become available. The human prion diseases have been traditionally classified into Creutzfeldt-Jakob disease (CJD), Gerstmann-Sträussler-Scheinker (GSS) disease and kuru. They can alternatively be classified into three causal categories: sporadic, acquired and inherited. The appearance of a new human prion disease, variant CJD (vCJD), in the United Kingdom from 1995 onwards, and the experimental evidence that this is caused by the same prion strain as that causing bovine spongiform encephalopathy (BSE) in cattle, has raised the possibility that a major epidemic of vCJD will occur in the United Kingdom and other countries as a result of dietary or other exposure to BSE prions. These concerns have led to intensified efforts to develop therapeutic interventions. Quinacrine has been previously used to treat other diseases such as malaria; however, it was found to have serious side effects and is no longer licensed in the United Kingdom. There is only very limited evidence from laboratory tests for the potential use of quinacrine in human prion disease, and the evidence to date for any possible clinical benefit is very scarce.
This trial is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.
The primary objective of this study is to evaluate the response rate and toxicity of the association R-CHOP with two schedules of administration of Velcade, in B-cell CD 20 + lymphoma patients, aged from 18 to 80 years The goal is to get a response rate at least at what observed with R-CHOP alone and will be evaluates with a sequential test. The other objective is to evaluate the toxicity The association of the monoclonal antibody Rituximab to chemotherapy regimen of B-cell lymphoma is associated with an increase response rate and event free survival when compared to chemotherapy alone (Coiffier et al NEJM 2002). It has been observed in almost all histological type of B-cell lymphomas. No significant increase of toxicity was observed especially in the most used regimen CHOP and the association R-CHOP is a standard for most B-cell malignancies CD20 positive. However, in patients with diffuse large cell lymphoma progress should be made as the complete response rate is below 75% in most situation and in low grade lymphoma, although patients respond well to chemotherapy complete remission rate averaged generally 50% (Marcus et al 2003), Czuczman et al 1999) . There is a need to improve this association with new innovative agent. Before running randomized study it is important to evaluate the like hood of getting improvement by phase 2 study testing tolerance and efficacy on a well established regimen. Bortezomib (Velcade formerly PS 341) is a proteasome inhibitor which has shown promising activity in the treatment of refractory myeloma.
The purpose of the PRIME Study is to examine the current management and outcomes of patients with mild cognitive impairment or dementia. Approximately 4500 patients will be enrolled in this disease registry across 12 sites in Australia. Clinical, treatment, health status and economic data will be acquired over 3 years. The study will identify the relationships among demographic variables, prognostic features, geographic setting, treatment options and clinical, economic and health status (activities of daily living and caregiver impact) outcomes. A complete record of patient care will be collected to provide detailed information on the management and outcome of mild cognitive impairment and dementia and the profile of patients at participating sites. The data will be used to build models looking at the effect of management of these conditions on principal clinical events, health status and economic outcomes. This will provide the foundation for subsequent objective and prospective evaluation of evidence-based strategies for the optimal treatment of mild cognitive impairment and dementia in Australia. This study is not prescriptive, but will instead examine the influence of a whole range of routinely used management strategies on clinical and economic outcomes among mild cognitive impaired and dementia patients in Australia. This 'practice based' approach is increasingly widely used and is a useful tool for elucidating the relative effectiveness of different management strategies and for exploring relationships between patient characteristics, treatment and outcomes. Observational study - no study drug administered.
This study aims to determine whether levodopa is effective in boosting learning and memory in healthy subjects and patients with dementia or Mild Cognitive Impairment. We also examine in healthy subjects using functional magnetic resonance imaging which brain regions mediate improved learning after levodopa administration. Prior work of our group shows that the dopamine precursor levodopa markedly improves word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind trial, we probe whether administration of levodopa improves learning performance as compared to placebo administration on neuropsychological tests and in an associative learning paradigm. We postulate that levodopa improves learning success and memory performance in healthy subjects, while the effect in patients with dementia or Mild Cognitive Impairment might depend on other factors, including severity of memory impairment.