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

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Massachusetts General Hospital
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00215163
First received: September 20, 2005
Last updated: May 29, 2013
Last verified: September 2005
  Purpose

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).


Condition Intervention Phase
Stress Disorders, Post-Traumatic
Drug: Cognitive-behavioral therapy and paroxetine-CR
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Trial of Paroxetine-CR for the Treatment of Patients With Post-Traumatic Stress Disorder (PTSD) Remaining Symptomatic After Initial Exposure Therapy

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Short PTSD Rating Interview (SPRINT)
  • Davidson Trauma Scale (DTS)

Secondary Outcome Measures:
  • 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

Enrollment: 17
Study Start Date: December 2002
Estimated Study Completion Date: June 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215163

Locations
United States, California
University of California at San Diego
San Diego, California, United States, 92093
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19122
Sponsors and Collaborators
Duke University
GlaxoSmithKline
Massachusetts General Hospital
Investigators
Principal Investigator: Jonathan Davidson, M.D. Duke University
  More Information

No publications provided by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00215163     History of Changes
Other Study ID Numbers: 4304, 4304-02-12
Study First Received: September 20, 2005
Last Updated: May 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
PTSD
Anxiety
CBT
Exposure
Paroxetine
Paroxetine-CR

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes
Paroxetine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014