Clinical trial NCT01621737: Antipsychotic Effects of Oxytocin
Official title: Antipsychotic Effects of Oxytocin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Keywords: oxytocin
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-06-18
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change in Total Score in the Positive and Negative Syndrome Scale (PANSS)From Baseline to Endpoint
timeFrame: 6 weeks
Secondary outcomes:
measure: Global Assessment of Functioning (GAF)
timeFrame: 6 weeks
measure: Clinical Global Impression-Severity of Illness (CGI-S)
timeFrame: 6 weeks
measure: Clinical Global Impression-Global Improvement (CGI-I)
timeFrame: 6 weeks
measure: Computerized Multiphasic Interactive Neurocognitive DualDisplayTM System (CMINDS®)
timeFrame: 6 weeks
measure: Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)
timeFrame: 6 weeks
measure: Calgary Depression Scale for Schizophrenia (CDSS)
timeFrame: 6 weeks
measure: Hamilton-Anxiety Scale (HAM-A)
timeFrame: 6 weeks
measure: Paranoid Thoughts Scale (PTS)
timeFrame: 6 weeks
measure: Treatment Satisfaction Questionnaire for Medication (TSQM)
timeFrame: 6 weeks
measure: Childhood Trauma Questionnaire (CTQ)
timeFrame: 6 weeks
measure: Experience Close Relationships (ECR)
timeFrame: 6 weeks
measure: Arizona Sexual Experience Scale (ASEX)
timeFrame: 6 weeks
measure: Social Phobia Inventory (SPIN)
timeFrame: 6 weeks
measure: Penn Emotion Recognition Test (ER-40)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: UCSD
name: David Feifel, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: UCI
name: Steven Potkin, MD
role: PRINCIPAL_INVESTIGATOR
References: