CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 91 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Placebo 40 mgfrom 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/NCT01681849
NCT01681849Phase 4Completed
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Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder

Emory University·interventional·Posted Sep 10, 2012·Updated Jun 28, 2017

In Brief

A Phase 4 clinical trial evaluating Placebo, Paroxetine, and 1 other intervention for PTSD. Completed, enrolled 91 participants across 1 site.

Detailed Summary

The purpose of this study was to assess the effects of the medication paroxetine on symptoms of posttraumatic stress disorder (PTSD) and the brain in women with a history of PTSD related to childhood abuse. The hypothesis is that paroxetine will result in an improvement in PTSD symptoms accompanied by changes in brain functional response to reminders of childhood trauma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPTSD
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 10, 2012
Enrollment StartJul 1, 2009
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 13.8 years ago

Interventions

Placebodrug

Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.

Paroxetinedrug

Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.

Positron Emission Tomography (PET) Imagingother

Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water with exposure to traumatic scripts