Antipsychotic Effects of Oxytocin
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Antipsychotic Effects of Oxytocin|
- Change in Total score in the Positive and Negative Syndrome Scale (PANSS)from baseline to endpoint [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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.
- Global Assessment of Functioning (GAF) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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 of Illness (CGI-S) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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 DualDisplayTM System (CMINDS®) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Oxytocin: Low Dose
42 IU BID for the six weeks
42 IU BID for six weeks
Experimental: Oxytocin: High Dose
84 IU BID for six weeks
84 IU BID for six weeks
|Placebo Comparator: Placebo||
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).
|Contact: Nicholas L Schaffner, B.A.||firstname.lastname@example.org|
|Contact: Patrice R Cobb, B.A.||email@example.com|
|United States, California|
|University of California, Irvine||Recruiting|
|Irvine, California, United States, 92037|
|Contact: Ioana Popica 714-456-8517 firstname.lastname@example.org|
|Principal Investigator: Steven Potkin, MD|
|University of California, San Diego||Recruiting|
|San Diego, California, United States, 92103|
|Contact: Nicholas L Schaffner, B.A. 619-543-5978 email@example.com|
|Contact: Patrice R Cobb, B.A. (619) 543-6495 firstname.lastname@example.org|
|Principal Investigator: David Feifel, MD, PhD|