Completed

Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder

What is being tested

Paroxetine

+ Positron Emission Tomography (PET) Imaging

+ Placebo

DrugOther

Who is being recruted

Trauma and Stressor Related Disorders+1

+ Mental Disorders

+ Stress Disorders, Traumatic

From 18 to 75 Years

+18 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 4

Interventional

Study Start: July 2009

See protocol details

Summary

Principal SponsorEmory University

Last updated: June 28, 2017

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2009

Actual date on which the first participant was enrolled.

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

NCT01681849

Principal SponsorEmory University

Last updated: June 28, 2017

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

91 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Trauma and Stressor Related DisordersMental DisordersStress Disorders, TraumaticStress Disorders, Post-Traumatic

Criteria

4 inclusion criteria required to participate

Non-PTSD subjects will be included based on the same criteria with the exception that they do not meet criteria for PTSD

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

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)

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)

14 exclusion criteria prevent from participating

Non-PTSD subjects will additionally be excluded with current major depression or other major psychiatric disorder based on the SCID

a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness

a history of shrapnel or other foreign bodies which would preclude MRI scanning

alcohol abuse or substance abuse or dependence based on the SCID within the past 24 months

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.

Group II

Placebo

Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.

Group III

Women who have experienced early childhood abuse and do not have PTSD will serve as a control group and complete baseline assessments. They do not undergo intervention therefore they are assessed at baseline only.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Emory University

Atlanta, United StatesOpen Emory University in Google Maps

CompletedOne Study Center