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RCT of CBT Combined With D-Cycloserine for Treating PTSD

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Information provided by:
Université de Montréal

Tracking Information
First Submitted Date  ICMJE March 26, 2007
First Posted Date  ICMJE March 27, 2007
Last Update Posted Date March 27, 2007
Study Start Date  ICMJE February 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2007)
  • Clinician-administered measures collected at initial assessment, post-treatment and six-months follow-up:
  • CAPS: PTSD symptoms
  • SCID: AXIS I disorders
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2007)
  • Patient self-report forms collected at initial assessment, post-treatment and six-months follow-up:
  • BDI: depression symptoms
  • BAI: anxiety symptoms
  • WHOQL-Bref: quality of life
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RCT of CBT Combined With D-Cycloserine for Treating PTSD
Official Title  ICMJE Comparative Study of the Efficacy of a Cognitive-Behavioral Therapy for Post-Traumatic Stress Disorder With or Without D-Cycloserine
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Post-Traumatic Stress Disorder
Intervention  ICMJE
  • Drug: D-cycloserine
  • Behavioral: Cognitive-Behavioral Therapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: March 26, 2007)
20
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00452231
Other Study ID Numbers  ICMJE CRFS2045
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Université de Montréal
Collaborators  ICMJE Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Investigators  ICMJE
Principal Investigator: Stéphane Guay Université de Montréal
PRS Account Université de Montréal
Verification Date March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP