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RCT of CBT Combined With D-Cycloserine for Treating PTSD

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: NCT00452231
Recruitment Status : Unknown
Verified March 2007 by Université de Montréal.
Recruitment status was:  Recruiting
First Posted : March 27, 2007
Last Update Posted : March 27, 2007
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Information provided by:
Université de Montréal

Brief Summary:
The purpose of this study is to investigate if the effectiveness of cognitive-behavioral therapy for post-traumatic stress disorder can be increased by combining it with D-cycloserine (TCC/D-cycloserine) by comparing with a placebo (TCC/placebo).

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Drug: D-cycloserine Behavioral: Cognitive-Behavioral Therapy Phase 2 Phase 3

Detailed Description:

Post-traumatic stress disorder (PTSD) is one of the most frequent anxiety disorder in the general population (Kessler and al., 2005). Currently, the treatment of choice for PTSD is cognitive-behavioral therapy (CBT; Foa, Davidson and Frances, 1999). Based on remission rates after treatment, successful outcomes of CBT for PTSD vary between 46 and 54 % when dropouts are considered, and between 56 and 70% among those who completed their therapy (Bradley and al., 2005). Thus, there is room for improvement.

Recently, the results of two published studies on the treatment of phobia of heights (Ressler and al., 2004) and social phobia (Hofman, 2006) indicated that the efficacy of CBT was increased by adding D-cycloserine. The superior efficacy of CBT/D-cycloserine over CBT/Placebo in the treatment of anxiety disorders can result from a greater release of glutamate, a substance facilitating the extinction of fear (Davis, Myers, Ressler and Rothbaum, 2005; Richardson, Ledgerwood an Cranney, 2004). However, to our knowledge, no study has yet compared CBT/D-cycloserine to CBT/Placebo in the treatment of PTSD. The main hypothesis of the current study is that the efficacy of CBT for PTSD will be increased when combined with D-cycloserine compared to a placebo.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparative Study of the Efficacy of a Cognitive-Behavioral Therapy for Post-Traumatic Stress Disorder With or Without D-Cycloserine
Study Start Date : February 2007
Estimated Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine

Primary Outcome Measures :
  1. Clinician-administered measures collected at initial assessment, post-treatment and six-months follow-up:
  2. CAPS: PTSD symptoms
  3. SCID: AXIS I disorders

Secondary Outcome Measures :
  1. Patient self-report forms collected at initial assessment, post-treatment and six-months follow-up:
  2. BDI: depression symptoms
  3. BAI: anxiety symptoms
  4. WHOQL-Bref: quality of life

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:

  • Clinical diagnosis of PTSD
  • No other Axix I disorder of higher intensity than PTSD
  • Accept not to start a psychopharmacological treatment before and during the participation to the project

Exclusion Criteria:

  • Substance abuse
  • Psychotic episodes (past or current)
  • Bipolar disorder
  • Organic caused mental disorder
  • Intellectual deficiency
  • Pregnant or breast-feeding woman
  • Épilepsy

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): NCT00452231

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Contact: Sarah Jane Parent (514) 251-4000 ext 3574
Contact: Cindy Beaudoin (514) 251-4000 ext 3574

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Canada, Quebec
Centre d'étude sur le Trauma Recruiting
Montréal, Quebec, Canada, H1N 3V2
Contact: Stéphane Guay, Ph.D.    (514) 251-4000 ext 3084   
Contact: André Marchand, Ph.D.    (514) 251-4000 ext 2510   
Principal Investigator: Stéphane Guay, Ph.D.         
Sub-Investigator: André Marchand, Ph.D.         
Sub-Investigator: Pierre Landry, M.D.         
Sponsors and Collaborators
Université de Montréal
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
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Principal Investigator: Stéphane Guay Université de Montréal

Layout table for additonal information Identifier: NCT00452231     History of Changes
Other Study ID Numbers: CRFS2045
First Posted: March 27, 2007    Key Record Dates
Last Update Posted: March 27, 2007
Last Verified: March 2007
Keywords provided by Université de Montréal:
Post-traumatic Stress Disorder
Cognitive-Behavioral Therapy
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action