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

Not Applicable

Terminated

Brief Summary: 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: Approximately 20 patients will be enrolled to participate in a 6 month flexible dose of oxytocin.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Vehicle placebo	Placebo	Placebo for 3 weeks

Primary Outcome Measures

Name	Time	Method
Change in Total Score in the Positive and Negative Syndrome Scale (PANSS) From Baseline to 28 Weeks	baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Global Assessment of Functioning (GAF)	28 weeks	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).
Clinical Global Impression-Severity	28 Weeks	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).
Clinical Global Impression-Global Improvement (CGI-I)	28 Weeks	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).
Computerized Multiphasic Interactive Neurocognitive DualDisplay TM System (CMINDS®)	28 weeks
Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)	28 Weeks