Antipsychotic Effects of Oxytocin

NCT ID: NCT01621737

Last Updated: 2019-11-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2018-12-31

Brief Summary

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.

Detailed Description

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).

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Oxytocin: Low Dose

42 IU BID for the six weeks

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

42 IU BID for six weeks

Oxytocin: High Dose

84 IU BID for six weeks

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

84 IU BID for six weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Vehicle placebo

Interventions

Oxytocin

42 IU BID for six weeks

Intervention Type: DRUG

Oxytocin

84 IU BID for six weeks

Intervention Type: DRUG

Placebo

Vehicle placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult men or women, 21 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 an atypical antipsychotic medication (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 screening and 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 DSM-IV diagnosis other than Schizophrenia.

Permitted:

• Subjects on one SSRI, and/or sleep medication (diphenhydramine, zolpidem, zaleplon, or diazepam), at a reasonable dose, as judged by the investigator, is permitted in this study. Minor adjustments in sleep medication are acceptable. Patients will be asked to notify the study doctor of any changes to sleep aids.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

David Feifel

Professor of Psychiatry and Neurosciences Program Director, Neuropsychiatry and Behavioral Medicine Program Director, UCSD Adult ADHD Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Feifel, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

UCSD

Steven Potkin, MD

Role: PRINCIPAL_INVESTIGATOR

UCI

Locations

University of California, Irvine

Irvine, California, United States

University of California, San Diego

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R34MH091285

Identifier Type: NIH

Identifier Source: secondary_id

View Link

111017

Identifier Type: -

Identifier Source: org_study_id

NCT01987050

Identifier Type: -

Identifier Source: nct_alias