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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00452231
Other study ID # CRFS2045
Secondary ID
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
Est. primary completion date
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


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
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