Antipsychotic Effects of Oxytocin

Study Overview
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Brief Summary
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The objective of the study is to compare the efficacy of intranasal oxytocin versus intranasal placebo to improve symptoms in schizophrenia patients who have residual symptoms despite being on adequate treatment with antipsychotic medication.

Detailed Description
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This is two-site clinical study taking place at UCSD and UCI. Approximately 71 patients at each site will be randomly assigned to either intranasal oxytocin or vehicle placebo at this site. The total duration for each individual subject will be 6 weeks on study medication (placebo or oxytocin).

Official Title
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Antipsychotic Effects of Oxytocin

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Oxytocin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men or women, 21 years of age or older. Meet DSM-IV criteria for Schizophrenia. Women of childbearing potential must test negative for pregnancy at the time of enrollment based on urine pregnancy test and agree to use a reliable method of birth control during the study. Must be on a therapeutic dose of an atypical antipsychotic medication (examples but not limited to Clozapine Olanzapine, Risperidone, Ziprasidone, Aripiprazole, Seroquel) with no major dose changes for at least 4 weeks. A minimum PANSS total score of 55 at screening and baseline and a score of at least 4 (moderate) on the subscale of the PANSS (suspiciousness/persecution) at screening. Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline. Must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent. Must be able to use nasal spray. Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator. Exclusion Criteria: Are pregnant or are breastfeeding (negative pregnancy test at screening). A urine drug screen performed at screening must not show evidence of recent use of drugs of abuse. Any active medical condition that in the opinion of the investigator will interfere with the objectives of the study. Are unsuitable in any way to participate in this study, in the opinion of the investigator. Another current DSM-IV diagnosis other than Schizophrenia. Permitted: Subjects on one SSRI, and/or sleep medication (diphenhydramine, zolpidem, zaleplon, or diazepam), at a reasonable dose, as judged by the investigator, is permitted in this study. Minor adjustments in sleep medication are acceptable. Patients will be asked to notify the study doctor of any changes to sleep aids.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin: Low Dose<br>42 IU BID for the six weeks | Drug: Oxytocin<br>* 42 IU BID for six weeks<br>|
| Experimental: Oxytocin: High Dose<br>84 IU BID for six weeks | Drug: Oxytocin<br>* 84 IU BID for six weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Vehicle placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Score in the Positive and Negative Syndrome Scale (PANSS)From Baseline to Endpoint | The three subscales of the PANSS include the Positive scale (7 items), the Negative scale (7 items), and the General Psychopathology scale (16 items). The total PANSS score is the sum of all 30 items of which each item is scored on a 1-7 rating system (7 indicating the worst symptoms). The items on the PANSS focus on symptoms that are common in patients with psychotic disorders and include hallucinations, delusions and disorganization as well as mood disturbances. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment of Functioning (GAF) | The GAF considers psychological, social, and occupational functioning on a hypothetical continuum of mental health illness. Scores on the GAF range from 1 (extremely severe) to 100 (superior functioning). | 6 weeks | 
| Clinical Global Impression-Severity of Illness (CGI-S) | The CGI-S is used to evaluate changes in overall severity of illness. Scores range from 1 (not at all) to 7 (among the most extremely ill). | 6 weeks | 
| Clinical Global Impression-Global Improvement (CGI-I) | The CGI-I is a global assessment to evaluate the subject's improvement or worsening from baseline. Scores on the CGI-I scale range from 1 (very much improved) to 7 (very much worse). | 6 weeks | 
| Computerized Multiphasic Interactive Neurocognitive DualDisplayTM System (CMINDS®) | The CMINDS ® consists of construct-equivalent computerized versions of the neurocognitive assessment instruments constituting the MATRICS™ Consensus Cognitive Battery (MCCB™). | 6 weeks | 
| Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME) | The MSCEIT™ ME is a multiple choice test that asses how individuals manage their emotions. | 6 weeks | 
| Calgary Depression Scale for Schizophrenia (CDSS) | The CDSS is a ten item diagnostic questionnaire intended to assess the severity of depression symptoms experienced by a given patient. | 6 weeks | 
| Hamilton-Anxiety Scale (HAM-A) | The HAM-A is a clinician administered scale for the evaluation of anxiety symptoms. It consists of 14 items of which each item is scored 0 (not present) to 4 (very severe). | 6 weeks | 
| Paranoid Thoughts Scale (PTS) | The PTS is a self-rated scale to assess current paranoia symptoms. The PTS consists of 32 items that the subject rates from 1 (not at all) to 5 (totally). | 6 weeks | 
| Treatment Satisfaction Questionnaire for Medication (TSQM) | The TSMQ is a brief questionnaire asking patients about how satisfied they were with the ease, timing, etc. of the study medication giving a good indication of adherence | 6 weeks | 
| Childhood Trauma Questionnaire (CTQ) | The CTQ is a validated measure of adverse early experiences characterized on a measure of Anxiety Sensitivity Index and retrospective childhood maltreatment. A 5-point frequency of occurrence scale is utilized: (1) never true, (2) rarely true, (3) sometimes true, (4) often true, and (5) very often true. Each sub-scale score ranges from 5 (no history of abuse or neglect) to 25 (very extreme history of abuse and neglect). | 6 weeks | 
| Experience Close Relationships (ECR) | The ECR is a self-rated questionnaire designed to assess individual differences with respect to attachment-related anxiety (i.e., the extent to which people are insecure vs. secure about the extent to which their partner's availability and responsiveness) and attachment-related avoidance (i.e., the extent to which people are uncomfortable being close to others vs. secure depending on others) . | 6 weeks | 
| Arizona Sexual Experience Scale (ASEX) | The ASEX is a self-rated scale to assess sexual functioning. The ASEX consists of 5 items that the subject will rate from 1 (extremely strong, easily, or satisfying) to 6 (absent or never) based on how he/she feels at the time. | 6 weeks | 
| Social Phobia Inventory (SPIN) | The SPIN is a patient self-report scale that measures the degree of social phobia in a variety of different social situations. | 6 weeks | 
| Penn Emotion Recognition Test (ER-40) | The ER-40 is a computerized emotion discrimination test presenting 40 color photographs of evoked happy, sad, anger, fear and neutral expressions balanced for poser gender and ethnicity. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxytocin