Intranasal Oxytocin in Schizophrenia Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | March 2012 |
| Contact: | Ioana Popica |
| Email: | ipopica@uci.edu |
| Phone: | 714-456-8517 |
A Double-Blind, Placebo Controlled Comparison of Two Fixed Doses of Oxytocin and Placebo Administered Intranasally in Schizophrenia Patients
The proposed study is a randomized, double-blind, placebo-controlled study of the value of
adjunctive intranasal oxytocin added to existing antipsychotic treatment compared with
adjunctive placebo in subjects with schizophrenia. Enrolled subjects will receive 6 weeks of
treatment with one of the following adjunctive to a stable antipsychotic regimen: 1) 84
International Units (IU)/day intranasal oxytocin (42 IU twice a day) 2) 168 IU/day
intranasal oxytocin (84 IU twice a day) or 3) intranasal placebo. The study will be
conducted over 2 years. Approximately eighty subjects will be entered into the study. We
hypothesize that augmentation of antipsychotics with intranasal oxytocin will significantly
improve psychopathology ratings as compared to placebo and an improvement in certain
cognitive functions may also be observed.
adjunctive intranasal oxytocin added to existing antipsychotic treatment compared with
adjunctive placebo in subjects with schizophrenia. Enrolled subjects will receive 6 weeks of
treatment with one of the following adjunctive to a stable antipsychotic regimen: 1) 84
International Units (IU)/day intranasal oxytocin (42 IU twice a day) 2) 168 IU/day
intranasal oxytocin (84 IU twice a day) or 3) intranasal placebo. The study will be
conducted over 2 years. Approximately eighty subjects will be entered into the study. We
hypothesize that augmentation of antipsychotics with intranasal oxytocin will significantly
improve psychopathology ratings as compared to placebo and an improvement in certain
cognitive functions may also be observed.
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 or typical antipsychotic medications
(for example, 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) on at least one symptom 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
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 DSM-IV diagnosis other than Schizophrenia. Vulnerable populations
will not be involved in this study.
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