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RCT of CBT Combined With D-Cycloserine for Treating PTSD

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00452231
Enrollment
20
Registered
2007-03-27
Start date
2007-02-28
Completion date
2008-07-31
Last updated
2007-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Traumatic Stress Disorder

Keywords

Post-traumatic Stress Disorder, Cognitive-Behavioral Therapy

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.

Interventions

DRUGD-cycloserine
BEHAVIORALCognitive-Behavioral Therapy

Sponsors

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
CollaboratorOTHER
Université de Montréal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
Clinician-administered measures collected at initial assessment, post-treatment and six-months follow-up:
CAPS: PTSD symptoms
SCID: AXIS I disorders

Secondary

MeasureTime frame
Patient self-report forms collected at initial assessment, post-treatment and six-months follow-up:
WHOQL-Bref: quality of life
BDI: depression symptoms
BAI: anxiety symptoms

Countries

Canada

Contacts

Primary ContactSarah Jane Parent
sparent.hlhl@ssss.gouv.qc.ca(514) 251-4000
Backup ContactCindy Beaudoin
beaudoincindy@hotmail.com(514) 251-4000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026