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

NCT ID: NCT02144155

Last Updated: 2019-12-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-12-31

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.

Conditions

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Schizophrenia

Keywords

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Oxytocin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Oxytocin: 24 IU - 168 IU

Oxytocin twice daily for 3 weeks

Group Type EXPERIMENTAL

Oxytocin: 24IU - 168 IU

Intervention Type DRUG

Oxytocin: 24IU - 168 IU

Vehicle placebo

Placebo for 3 weeks

Group Type SHAM_COMPARATOR

Oxytocin: 24IU - 168 IU

Intervention Type DRUG

Oxytocin: 24IU - 168 IU

Placebo

Intervention Type DRUG

placebo drug

Interventions

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Oxytocin: 24IU - 168 IU

Oxytocin: 24IU - 168 IU

Intervention Type DRUG

Placebo

placebo drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Adult men or women, 18 years of age or older.
2. Meet DSM-IV criteria for Schizophrenia
3. 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.
4. 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.
5. 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.
6. Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline;
7. Must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent.
8. Must be able to use nasal spray
9. Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.

Exclusion Criteria

1. Are pregnant or are breastfeeding (negative pregnancy test at screening)
2. A urine drug screen performed at screening must not show evidence of recent use of drugs of abuse
3. Any active medical condition that in the opinion of the investigator will interfere with the objectives of the study
4. Are unsuitable in any way to participate in this study, in the opinion of the investigator.
5. Another current, primary DSM-IV diagnosis other than Schizophrenia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCSD Medical Center - Hillcrest

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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120005

Identifier Type: -

Identifier Source: org_study_id