CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
Oxytocin +1 moredrug
Likely dose
Oxytocin 40 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/NCT03238924
NCT03238924Phase 2Completed
CompareCT.gov

Augmenting Prolonged Exposure Therapy for PTSD With Intranasal Oxytocin

Medical University of South Carolina·interventional·Posted Aug 3, 2017·Updated May 25, 2018

In Brief

A Phase 2 clinical trial evaluating Oxytocin and Placebos for PTSD. Completed, enrolled 17 participants.

Detailed Summary

Posttraumatic stress disorder (PTSD) is a chronic, debilitating anxiety disorder that may develop after direct or indirect exposure to traumatic events. Prolonged Exposure (PE) is a cognitive-behavioral psychotherapy modality with a wealth of empirical support demonstrating its efficacy to treat PTSD in a variety of populations. The neuropeptide oxytocin is a promising new pharmacotherapeutic agent with prominent anxiolytic effects . Despite a strong biological and theoretical rationale for investigating the potential effectiveness of augmenting PE with intranasal oxytocin, no studies to date have done so. The current study aims to address this important gap in the literature by examining changes in PTSD symptoms following PE treatment combined with a) 40 IU of intranasal oxytocin or b) placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPTSD
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 3, 2017
Enrollment StartJan 1, 2015
Primary CompletionDec 31, 2016
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 8.9 years ago

Interventions

Oxytocindrug

40 IU oxytocin nasal spray, self-administered

Placebosdrug

Saline nasal spray, self-administered