Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Placebo-controlled Trial of Vasopressin Treatment for Social Deficits in Children With Autism
Brief Summary: Researchers at the Stanford University School of Medicine are seeking participants for a study examining the effectiveness of vasopressin, a neuropeptide, in treating children with autism spectrum disorder. Difficulty with social interactions is characteristic of people with autism, who often have problems interpreting facial expressions or maintaining eye contact while talking with someone. There are currently no effective medicines available to treat social problems in individuals with autism. Neuropeptides, such as vasopressin and oxytocin, are molecules used by neurons in the brain to communicate with one another. Vasopressin is closely related to oxytocin, which is currently being tested as a treatment for autism, and has been shown to enhance social functioning in animals. Animal studies have shown that when the proper functioning of vasopressin is experimentally altered, animals develop a variety of social deficits, including impaired memory for peers and a reduced interest in social interaction. Researchers found that when vasopressin was administered to mice with a genetically induced form of autism, their social functioning improved. Vasopressin is already approved by the Food and Drug Administration for use in humans, and has proved to be a successful treatment for some common pediatric conditions, including bedwetting. Similar to oxytocin, it also has been shown to improve social cognition and memory in people who do not have autism. The researchers will test the effects of vasopressin on social impairments in 50 boys and girls with autism, ages 6 to 12 years old. The study will last four weeks for each participant. Participants will receive either vasopressin or a placebo nasal spray. At the end of this phase of the study, those who received the placebo will have the option of participating in a four-week trial during which they will be given vasopressin. Stanford is the only site for the study. Participants do not need to live locally but will need to come to the Stanford University Department of Psychiatry and Behavioral Sciences for study visits.


Options:
A: Inclusion Criteria:

* Diagnosis of an autism spectrum disorder (autistic disorder, Asperger's syndrome, and pervasive developmental disorder, not otherwise specified).
* Significant hyperactivity, inattention, or impulsivity as determined by a score on an investigator-administered ADHD Rating Scale (ADHDRS)-Home Version that is at least 1.5 standard deviations above the mean for age and sex
* Parent/caregiver's primary complaint about the child is inattention, hyperactivity, and/or impulsivity ("ADHD" symptoms)
* Symptoms present for 6 months prior to study entry
* Psychotropic drug-free for at least 2 weeks prior to starting study medication. This drug-free period will be 5 weeks for fluoxetine (Prozac).

Exclusion Criteria:

* Weighs less than 15 kg (about 33 pounds)
* Any another psychiatric disorder that may require a different treatment, including psychotic disorders, major affective disorders, obsessive-compulsive disorder, panic disorder, or substance-related disorders
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of Rett's disorder or childhood disintegrative disorder
* Presence of extreme aggression or self-injury
* Currently taking an effective psychotropic drug
* Currently using other medications that may be unsafe to take with atomoxetine (e.g., potent CYP 2D6 inhibitors, intravenous albuterol, monoamine oxidase inhibitors\[MAO\])
* Inability to swallow study medication
* Presence of a medical condition that would make treatment with atomoxetine unsafe (e.g., unstable hypertension or cardiac disease, asthma requiring frequent treatment with albuterol, narrow angle glaucoma, pregnancy, etc.)
* Mental age of less than 18 months
* Previous adequate trial of atomoxetine
* Previous evidence of hypersensitivity or an allergic reaction to atomoxetine
* Clinically significant abnormalities in laboratory measures indicating an undiagnosed medical condition as determined by the study physician in discussion with the participant's primary care physician
* Clinically significant abnormalities on ECG as determined by a pediatric cardiologist
* Pregnant
* Initiation of a new psychosocial intervention within 90 days prior to starting study medication. Participants who have recently had a significant change in their psychosocial interventions will not be eligible until this intervention has been stable for 90 days in order to avoid confounding results of the study. Stable interventions (e.g., speech and occupational therapy) will be allowed to continue during the course of the study. Minor changes in ongoing treatment (e.g., missed therapy sessions due to holiday/vacation planned break in therapy due to school holidays) will not be considered significant.
B: Inclusion Criteria:

* medically healthy outpatients between 6 and 12 years of age (cut off: 12 years and 11 months)
* Intelligence Quotient (IQ) equal to or greater than 50 (Stanford-Binet)
* Social Responsiveness Scale (SRS) Total Score equal to or greater than 70
* ability to complete laboratory and cognitive testing
* diagnosis of Autism Spectrum Disorder (ASD) based on expert clinical opinion and confirmed on the Autism Diagnostic Interview-Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS)
* Clinical Global Impression (CGI) severity rating of 4 or higher
* care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interact with the participant on a regular basis
* stable medications for at least 4 weeks
* no planned changes in psychosocial interventions during the trial
* no concurrent participation in any other clinical research trials
* willingness to provide blood samples and electrocardiogram

Exclusion Criteria:

* diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or psychotic disorder
* regular nasal obstruction or nosebleeds
* active and unstable medical problems (e.g., migraine; asthma; seizure disorder; anaphylaxis; epilepsy; diabetes; serious liver, renal, or cardiac pathology)
* clinically significant abnormal vital signs or ECG reading
* evidence of a genetic mutation know to cause ASD (e.g., Fragile X Syndrome) or metabolic disorder
* significant hearing or vision impairments
* drinks large volumes of water (e.g., habitual or psychogenic polydipsia)
* pregnant or sexually active females not using a reliable method of contraception (urine pregnancy test will be conducted)
* history of hypersensitivity to vasopressin, its analogs (e.g., Desmopressin), or compounding preservatives (e.g., chlorobutanol)
* current use of any medications known to interact with vasopressin including: 1) carbamazepine (i.e., Tegretol); chlorpropamide; clofibrate; urea; fludrocortisone; tricyclic antidepressants (all of which may potentiate the antidiuretic effect of vasopressin when used concurrently); 2) demeclocycline; norepinephrine; lithium; heparin; alcohol (all of which may decrease the antidiuretic effect of vasopressin when used concurrently); 3) ganglionic blocking agents including benzohexonium, chlorisondamine, pentamine (all of which may produce a marked increase in sensitivity to the pressor effects of vasopressin)
* prior or current use of vasopressin
* abnormal chemistry result
C: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Meets diagnostic criteria for autism

--Prior/Concurrent Therapy--

Other:

* At least 3 months since prior electroconvulsive therapy
* At least 1 month since prior investigational drugs or treatment with any drug known to cause major organ toxicity
* At least 2 weeks since prior monoamine oxidase inhibitors
* At least 6 weeks since prior long acting phenothiazines
* At least 1 week since prior other psychotropic drugs
* No prior fluoxetine of 20 mg/day for 6 weeks
* At least 6 weeks since prior fluoxetine
* No concurrent use of terfenadine (Seldane) or astemizole (Hismanal)
* No concurrent electroconvulsive therapy or other psychotropic drugs (unless otherwise permitted)
* Prior participation in another serotonin reuptake inhibitor trial allowed

--Patient Characteristics--

Hematopoietic: No significant hematopoietic disease

Hepatic: No prior or concurrent liver disease

Renal: No prior or concurrent kidney disease

Cardiovascular:

* No significant cardiovascular disease
* No abnormal EKG

Neurological:

* No prior seizure disorder or high risk development of seizures
* No prior cerebrovascular disease
* No prior brain trauma

Other:

* Not pregnant or nursing
* Negative pregnancy test
* No unstable major medical illness or systemic disease
* No moderate or severe mental retardation and motor deficits (IQ less than 50)
* No family history of bipolar disorder
* No prior or concurrent other mental disorders (e.g., schizophrenia, schizoaffective, organic, or bipolar disorders)
* No significant autoaggressive behavior or serious suicidal risk
* No prior or concurrent gastrointestinal conditions
* No unstable endocrine disease (e.g., hypo or hyperthyroidism)
* No prior or concurrent malignancy
* Must be able to tolerate tapering of psychoactive medication
* No history of hypersensitivity or severe side effects to fluoxetine or other serotonin reuptake inhibitors
* No history of severe personality disorder or noncompliance
D: Inclusion Criteria:

* DSM-IV diagnosis of Autistic Disorder (299.00)
* ABC-I Subscale score of greater than or equal to 18
* CGI-S of greater than or equal to 4
* mental age \>18 months, body weight of at least 20 kg, seizure-free for at least 6 consecutive months and if on anticonvulsants must be on a dosage that has been stable for at least 4 weeks
* Medication free for 1 week before the start of the study for all psychotropic drugs, except 4 weeks for fluoxetine and at least 8 weeks for injectable medications
* Female patients must be premenarchal or sexually abstinent or, if heterosexually active, must practice an effective method of birth control.

Exclusion Criteria:

* History of prior or current DSM-IV psychotic disorder (e.g., schizophrenia, bipolar disorder, other psychosis), Pervasive Developmental Disorder not otherwise specified (PDD NOS), Asperger's, or Rett's
* Any history of hypersensitivity to risperidone, or its excipients in formulation, or other known drug allergy
* Patients who received risperidone within 3 months before screening (except p.r.n. use)
* Patients who did not demonstrate sufficient clinical response to an adequate trial of risperidone treatment in the past (an adequate trial is defined as a period of at least 4 weeks at an adequate dose)
* Neurologic disorder (e.g., Neuroleptic Malignant Syndrome, seizure disorders that are unstable, seizure activity within the past 6 months)
* History of alcohol or substance dependence within 3 months of screening
* Female subject who is pregnant (positive beta-HCG) or breast feeding
* Patients with existing moderate or severe EPS or history of tardive dyskinesia
* Patients who have received an experimental drug or used an experimental medical device within 3 months before the planned start of treatment.

Answer: B