RCT of CBT Combined With D-Cycloserine for Treating PTSD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-07-31

Brief Summary

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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

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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.

Conditions

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Post-Traumatic Stress Disorder

Keywords

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Post-traumatic Stress Disorder Cognitive-Behavioral Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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D-cycloserine

Intervention Type DRUG

Cognitive-Behavioral Therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Stéphane Guay

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Locations

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Centre d'étude sur le Trauma

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Sarah Jane Parent

Role: CONTACT

Phone: (514) 251-4000

Email: [email protected]

Cindy Beaudoin