Clinical trial NCT02144155: Open-label Study of the Efficacy of Intranasal Oxytocin in Schizophrenia
Official title: Open-label Study of the Long-Term Efficacy of Intranasal Oxytocin in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Keywords: Oxytocin
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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: Approximately 20 patients will be enrolled to participate in a 6 month flexible dose of oxytocin.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Total Score in the Positive and Negative Syndrome Scale (PANSS) From Baseline to 28 Weeks
timeFrame: baseline and 28 weeks
Secondary outcomes:
measure: Global Assessment of Functioning (GAF)
timeFrame: 28 weeks
measure: Clinical Global Impression-Severity
timeFrame: 28 Weeks
measure: Clinical Global Impression-Global Improvement (CGI-I)
timeFrame: 28 Weeks
measure: Computerized Multiphasic Interactive Neurocognitive DualDisplay TM System (CMINDS®)
timeFrame: 28 weeks
measure: Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)
timeFrame: 28 Weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Center - Hillcrest
state: California
Study officials:
References: