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

University of California San Diego

Status: Terminated

Conditions: Schizophrenia

Treatments: Drug: Oxytocin: 24IU - 168 IU; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02144155

120005

Details and patient eligibility

About

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.

Full description

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

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

14 participants in 2 patient groups

Oxytocin: 24 IU - 168 IU

Experimental group

Description:

Oxytocin twice daily for 3 weeks

Treatment:

Drug: Oxytocin: 24IU - 168 IU

Vehicle placebo

Sham Comparator group

Description:

Placebo for 3 weeks

Treatment:

Drug: Placebo

Drug: Oxytocin: 24IU - 168 IU