CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 68 enrolled
Drug / intervention
Intranasal Oxytocin Spraydrug
Likely dose
Intranasal Oxytocin Spray 24IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01394471
NCT01394471Phase 1Completed
CompareCT.gov

Oxytocin Treatment of Social Cognitive and Functional Deficits in Schizophrenia

University of North Carolina, Chapel Hill·interventional·Posted Jul 14, 2011·Updated Jun 11, 2015

In Brief

A Phase 1 clinical trial evaluating Intranasal Oxytocin Spray for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 68 participants across 1 site.

Detailed Summary

Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, improves social cognition, psychotic symptoms and social functioning in schizophrenia. Participants: 80 adults with schizophrenia or schizoaffective disorder for at least one year. Procedures (methods): Oxytocin or placebo will be administered twice daily in an intranasal spray for 12 weeks. Before, during and at the end of the trial, each subject will undergo psychiatric symptom ratings and tests of mental abilities used in social functioning, cognition, and social competence.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 14, 2011
Enrollment StartJul 1, 2011
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 15.0 years ago

Interventions

Intranasal Oxytocin Spraydrug

6 insufflations (24IU of oxytocin total) given twice daily for 12 weeks