drugset / Trial / NCT01028677

Oxytocin Treatment of Schizophrenia

NCT01028677 ↗

RandomizedParallel-groupTriple-blindTreatment

Summary

Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, improves social cognition, social functioning and decreases paranoia and other psychotic symptoms in schizophrenia. Participants: Up to 80 adults with schizophrenia for at least one year and with a high rating for paranoia. Procedures (methods): Oxytocin or placebo will be administered twice daily in an intranasal spray (6 insufflations/dose or 24 IU) for 6 weeks. Before, during and at the end of the trial, each subject will undergo social cognitive measures (primary outcomes) and psychiatric symptom ratings (secondary outcomes).

Timeline

Start
2009-11
Primary completion
2011-03
Completion
2011-03

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Intranasal Spray With Oxytocin; p = .61; t-test, 1 sided; note: Not adjusted for multiple comparisons NCT01028677 ↗

registry analysis (superiority or other test); Intranasal Spray With Oxytocin vs Intranasal Spray Without Oxytocin; p = .03; t-test, 2 sided NCT01028677 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxytocin Peptide 24 iu Intranasal