Antipsychotic Effects of Oxytocin

University of California, San Diego42 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Schizophrenia

Interventions

OxytocinDRUG

42 IU BID for six weeks

OxytocinDRUG

84 IU BID for six weeks

PlaceboDRUG

Vehicle placebo

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (2)

University of California, Irvine

Irvine, California, United States

University of California, San Diego

San Diego, California, United States

Outcomes

Primary Outcomes

Change in Total Score in the Positive and Negative Syndrome Scale (PANSS)From Baseline to Endpoint

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.

Time frame: 6 weeks

Secondary Outcomes

Global Assessment of Functioning (GAF)

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).

Time frame: 6 weeks

Clinical Global Impression-Severity of Illness (CGI-S)

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).

Time frame: 6 weeks

Clinical Global Impression-Global Improvement (CGI-I)

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).

Time frame: 6 weeks

Computerized Multiphasic Interactive Neurocognitive DualDisplayTM System (CMINDS®)

The CMINDS ® consists of "construct-equivalent computerized versions of the neurocognitive assessment instruments constituting the MATRICS™ Consensus Cognitive Battery (MCCB™).

Time frame: 6 weeks

Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)

Data from ClinicalTrials.gov

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