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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT02144155

Run by

University of California, San Diego

People needed

14

Starts

2012-03-01

Expected to finish

2014-12-01

Last updated by the study team

2019-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UCSD Medical Center - Hillcrest — San Diego, California, United States

Full record on ClinicalTrials.gov

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