NCT00215163

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2002

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

May 30, 2013

Status Verified

September 1, 2005

First QC Date

September 20, 2005

Last Update Submit

May 29, 2013

Conditions

Stress Disorders, Post-Traumatic

Keywords

PTSDAnxietyCBTExposureParoxetineParoxetine-CR

Outcome Measures

Primary Outcomes (2)

  • Short PTSD Rating Interview (SPRINT)

  • Davidson Trauma Scale (DTS)

Secondary Outcomes (12)

  • 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)

  • +7 more secondary outcomes

Interventions

Cognitive-behavioral therapy and paroxetine-CRDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of California at San Diego

San Diego, California, 92093, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19122, United States

Location

Related Publications (1)

  • Simon NM, Connor KM, Lang AJ, Rauch S, Krulewicz S, LeBeau RT, Davidson JR, Stein MB, Otto MW, Foa EB, Pollack MH. Paroxetine CR augmentation for posttraumatic stress disorder refractory to prolonged exposure therapy. J Clin Psychiatry. 2008 Mar;69(3):400-5. doi: 10.4088/jcp.v69n0309.

    PMID: 18348595DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jonathan Davidson, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

December 1, 2002

Study Completion

June 1, 2006

Last Updated

May 30, 2013

Record last verified: 2005-09

Locations

US(4)