CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 17 enrolled
Drug / intervention
intranasal spray with oxytocin +1 moredrug
Likely dose
intranasal spray with oxytocin 24 IUfrom 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/NCT01028677
NCT01028677N/ACompleted
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Oxytocin Treatment of Social Deficits and Paranoia in Schizophrenia

University of North Carolina, Chapel Hill·interventional·Posted Dec 9, 2009·Updated Apr 18, 2017

In Brief

A clinical study evaluating intranasal spray with oxytocin and nasal spray without oxytocin for Paranoia and 2 related conditions. Completed, enrolled 17 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParanoia, Schizophrenia, Schizoaffective Disorder
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2009
Enrollment StartNov 1, 2009
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.6 years ago

Interventions

intranasal spray with oxytocindrug

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

nasal spray without oxytocinother

6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks