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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00215163
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 30, 2013
Massachusetts General Hospital
Information provided by (Responsible Party):
Duke University

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).

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : December 2002
Study Completion Date : June 2006

Primary Outcome Measures :
  1. Short PTSD Rating Interview (SPRINT)
  2. Davidson Trauma Scale (DTS)

Secondary Outcome Measures :
  1. Clinical Global Impressions Severity Scale (CGI-S)
  2. Clinical Global Impressions Improvement Scale (CGI-I)
  3. Posttraumatic Diagnostic Scale (PDS)
  4. Beck Depression Inventory (BDI)
  5. Quality of Life Enjoyment and Satisfaction Questionnaire/General Activities Subscale (Q-LES-Q/GA)
  6. Sheehan Disability Scale (SDS)
  7. Connor-Davidson Resilience Scale (CD-RISC)
  8. Post-Traumatic Cognitions Inventory (PTCI)
  9. Severity of Symptoms Scale (SOSS)
  10. Pittsburgh Sleep Quality Index (PSQI)
  11. World Assumptions Scale (WAS)
  12. Mood-SR Lifetime

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00215163

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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
Massachusetts General Hospital
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Principal Investigator: Jonathan Davidson, M.D. Duke University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Duke University Identifier: NCT00215163    
Other Study ID Numbers: 4304
4304-02-12 ( Other Identifier: Duke IRB# )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: September 2005
Keywords provided by Duke University:
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors