RCT of CBT Combined With D-Cycloserine for Treating PTSD

Post-Traumatic Stress Disorder Clinical Trial

Official title:

Comparative Study of the Efficacy of a Cognitive-Behavioral Therapy for Post-Traumatic Stress Disorder With or Without D-Cycloserine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00452231
• Other study ID #: CRFS2045
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 26, 2007
• Last updated: March 26, 2007
• Start date: February 2007
• Est. completion date: July 2008

Study information

• Verified date: March 2007
• Source: Université de Montréal
• Contact: Sarah Jane Parent
• Phone: (514) 251-4000
• Email: sparent.hlhl[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• D-cycloserine

Behavioral:
• Cognitive-Behavioral Therapy

Locations

Country	Name	City	State
Canada	Centre d'étude sur le Trauma	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Montréal	Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician-administered measures collected at initial assessment, post-treatment and six-months follow-up:
Primary	CAPS: PTSD symptoms
Primary	SCID: AXIS I disorders
Secondary	Patient self-report forms collected at initial assessment, post-treatment and six-months follow-up:
Secondary	BDI: depression symptoms
Secondary	BAI: anxiety symptoms
Secondary	WHOQL-Bref: quality of life