Schizophrenia Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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