drugset / Trial / NCT01598623

Administrating Oxytocin to Treat Treatment Schizophrenia and Schizo-affective Patients

NCT01598623 ↗

Phase 2 Unknown 48 enrolled Sheba Medical Center
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objectives of the study are: 1. To evaluate the effect of OT compared to placebo, as add-on to anti-psychotics, on social functioning in schizophrenia. 2. To evaluate the effect of socially oriented CBT administered to patients immediately after they receive OT, compared to patients who receive OT with not-socially oriented CBT, and compared to patients who receive socially oriented CBT without OT. The investigators hypothesize that OT and socially oriented CBT will have a synergistic effect, and will be better than OT or CBT alone. 3. Use a detailed, in depth analysis of social interaction to assess these putative effects of OT. The investigators hypothesize that the use of this analysis will show larger treatment effects of OT than previously shown in less sensitive assessments, such as PANSS. 4. To assess the effect of epigenetic status on response to OT. The investigators hypothesize that epigenetic variants associated with lower OT plasma levels will be associated with greater response to OT treatment. 5. To assess in the relationships between levels of salivary OT and vasopressin, and social interactions in schizophrenia. 6. To assess in the relationships between levels of salivary OT and vasopressin, and response to OT treatment.

Timeline

Start
2012-05
Primary completion
2014-02
Completion
2014-09

Outcome

Missed primary endpoint

paper No significant difference was found between groups in the total CIB or PANSS scores. PMID 39502135 ↗

paper oxytocin did not influence participants' social behavior, and was not effective in improving the symptoms of schizophrenia. PMID 39502135 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxytocin Peptide 24 iu Intranasal

Indications

No indication recorded.