Open-label Study of the Efficacy of Intranasal Oxytocin in Schizophrenia

Study Overview
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Brief Summary
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The Objective of this study is to investigate the long-term efficacy of intranasal oxytocin in improvement of symptoms in patients with schizophrenia who have residual symptoms dispute being on adequate treatment with antipsychotic medication.

Detailed Description
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Approximately 20 patients will be enrolled to participate in a 6 month flexible dose of oxytocin.

Official Title
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Open-label Study of the Long-Term Efficacy of Intranasal Oxytocin in Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Oxytocin: 24IU - 168 IU
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men or women, 18 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 1 or 2 atypical antipsychotic medications (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 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, primary DSM-IV diagnosis other than Schizophrenia

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin: 24 IU - 168 IU<br>Oxytocin twice daily for 3 weeks | Drug: Oxytocin: 24IU - 168 IU<br>* Oxytocin: 24IU - 168 IU<br>|
| Sham Comparator: Vehicle placebo<br>Placebo for 3 weeks | Drug: Oxytocin: 24IU - 168 IU<br>* Oxytocin: 24IU - 168 IU<br>Drug: Placebo<br>* placebo drug<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 28 Weeks | 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. | baseline and 28 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). | 28 weeks | 
| Clinical Global Impression-Severity | 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). | 28 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). | 28 Weeks | 
| Computerized Multiphasic Interactive Neurocognitive DualDisplay TM System (CMINDS®) |  | 28 weeks | 
| Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME) |  | 28 Weeks | 

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