Paroxetine-CR to Treat Post-Traumatic Stress Disorder (PTSD) Symptomatic After Initial Exposure Therapy

May 29, 2013 updated by: Duke University

Randomized Trial of Paroxetine-CR for the Treatment of Patients With Post-Traumatic Stress Disorder (PTSD) Remaining Symptomatic After Initial Exposure Therapy

Both pharmacotherapeutic and psychosocial interventions have domenstrated efficacy for PTSD. However, although these interventions can be helpful, many patients remain symptomatic despite initial treatment. In this study, we will examine the relative efficacy of the addition of paroxetine-CR compared to placebo for patients remaining symptomatic despite a brief and intensive course of cognitive-behavioral therapy (CBT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a systematic controlled study examining the use of augmentation with pharmaotherapy for PTSD patients remaining symptomatic despite CBT (exposure therapy). The aims of the study include examination of: (1) the efficacy of paroxetine-CR compared to placebo as additions to ongoing exposure therapy in patients who failed to respond to brief, intensive CBT; (2) the tolerability of paroxetine-CR compared to placebo as additions to ongoing exposure therapy in patients who failed to respond to brief, intensive CBT; (3) the outcome of patients at 6 months follow-up to randomized treatment. Patients will initially have intensive (8 sessions over 4 weeks) prolonged exposure therapy. Patients who remain symptomatic will be randomzied to receive either flexibly-dosed paroxetine-CR (12.5 mg/d - 62.5 mg/d) or placebo in conjunction with additional 5 sessions of prolonged exposure over 10 weeks.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92093
        • University of California at San Diego
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19122
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female outpatients at least 18 years of age with a primary (the condition that is most central to the patient's current distress) psychiatric diagnosis of PTSD as defined by DSM-IV criteria
  • Patients must have remained symptomatic (CGI-S > or = 3) and a score of at least 6 on the SPRINT after a minimum of 7 sessions of prolonged exposure (delivered within 6 weeks) to be eligible for randomized treatment.

Exclusion Criteria:

  • Serious medical illness or instability for which hospitalization may be likely within the next 3 months
  • Pregnant or lactating women or those of childbearing potential not using medically accepted forms of contraception
  • Concurrent use of other psychotropic medications
  • Lifetime diagnosis of schizophrenia or any other psychotic disorder, mental retardation, organic mental disorders, or bipolar disorder
  • Obsessive-Compulsive Disorder, eating disorders, or alcohol/substance abuse disorders within the last 6 months
  • A current primary diagnosis of major depression, dysthymia, social anxiety disorder, and generalized anxiety disorder
  • A history of hypersensitivity or poor response to paroxetine or those using antidepressants, buspirone, or beta-blockers within 2 weeks of randomization
  • Concurrent dynamic or supportive psychotherapy if started within 2 months prior to onset of study entry

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Short PTSD Rating Interview (SPRINT)
Davidson Trauma Scale (DTS)

Secondary Outcome Measures

Outcome Measure
Clinical Global Impressions Severity Scale (CGI-S)
Clinical Global Impressions Improvement Scale (CGI-I)
Posttraumatic Diagnostic Scale (PDS)
Beck Depression Inventory (BDI)
Quality of Life Enjoyment and Satisfaction Questionnaire/General Activities Subscale (Q-LES-Q/GA)
Sheehan Disability Scale (SDS)
Connor-Davidson Resilience Scale (CD-RISC)
Post-Traumatic Cognitions Inventory (PTCI)
Severity of Symptoms Scale (SOSS)
Pittsburgh Sleep Quality Index (PSQI)
World Assumptions Scale (WAS)
Mood-SR Lifetime

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Massachusetts General Hospital
GlaxoSmithKline

Investigators

  • Principal Investigator: Jonathan Davidson, M.D., Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4304
  • 4304-02-12 (Other Identifier: Duke IRB#)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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