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Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder | Clinical Trials | Clareo Health

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Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder

NCT01681849•Emory University

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.

Detailed Description

The main purpose of this study was to look at the effects of paroxetine on PTSD symptoms and brain function in women with posttraumatic stress disorder (PTSD) related to childhood abuse. Participants underwent baseline assessment with of PTSD symptoms measured with the Clinician Administered PTSD Scale (CAPS) and brain function during exposure to traumatic scripts of childhood abuse. Participants then were treated in a randomized double-blind fashion with paroxetine or placebo for three months, followed by a repeat of these assessments. Specific Aims of this proposal were therefore to: * Assess the effects of paroxetine on PTSD symptoms * Assess the effects of paroxetine on brain function in conjunction with exposure to traumatic scripts using positron emission tomography (PET) with O-15 water

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects meet criteria for current PTSD as determined by the Structured Clinical Interview for DSMIV (SCID) interview for PTSD and the Clinician Administered PTSD Scale (CAPS) and have a score of greater than 60 on the CAPS
•history of penetrative sexual abuse which occurred once a month or more, for a period of greater than a year at some time between the ages of 4-13, as assessed by the Early Trauma Inventory (ETI)
•are free of psychotropic medication for four weeks before the study (subjects will not be taken off of medication for the purpose of the study).
•Non-PTSD subjects will be included based on the same criteria with the exception that they do not meet criteria for PTSD.

Exclusion Criteria

•a history of shrapnel or other foreign bodies which would preclude MRI scanning
•meningitis
•traumatic brain injury
•neurological disorder or organic mental disorder
•history of loss of consciousness
•alcohol abuse or substance abuse or dependence based on the SCID within the past 24 months
•positive pregnancy test as measured by a serum beta-HCG or urine pregnancy test on the morning of the PET scan. Women will be counseled about the risks of pregnancy during the course of the study
•current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia, based on the SCID
•a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness
•evidence of a major medical or neurological illness on physical examination or as a result of laboratory studies (CBC, BUN, creatinine, blood sugar, electrolytes, liver and thyroid function tests, urinalysis, and EKG)
+4 more criteria

Locations (1)

Emory University

Atlanta, Georgia, United States

Key Dates

Start Date

July 1, 2009

Primary Completion Date

July 1, 2015

Completion Date

July 1, 2015

Last Updated

June 28, 2017

Enrollment

ACTUAL participants

Conditions

PTSD

Interventions

Placebo

DRUG

Paroxetine

DRUG

Positron Emission Tomography (PET) Imaging

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 28, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder

Inclusion Criteria

Exclusion Criteria

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