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RCT of CBT Combined With D-Cycloserine for Treating PTSD

Primary Purpose

Post-Traumatic Stress Disorder

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
D-cycloserine
Cognitive-Behavioral Therapy
Sponsored by
Université de Montréal
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Post-traumatic Stress Disorder, Cognitive-Behavioral Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre d'étude sur le TraumaRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 26, 2007
Last Updated
March 26, 2007
Sponsor
Université de Montréal
Collaborators
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT00452231
Brief Title
RCT of CBT Combined With D-Cycloserine for Treating PTSD
Official Title
Comparative Study of the Efficacy of a Cognitive-Behavioral Therapy for Post-Traumatic Stress Disorder With or Without D-Cycloserine
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Université de Montréal
Collaborators
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
Post-traumatic Stress Disorder, Cognitive-Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
D-cycloserine
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy
Primary Outcome Measure Information:
Title
Clinician-administered measures collected at initial assessment, post-treatment and six-months follow-up:
Title
CAPS: PTSD symptoms
Title
SCID: AXIS I disorders
Secondary Outcome Measure Information:
Title
Patient self-report forms collected at initial assessment, post-treatment and six-months follow-up:
Title
BDI: depression symptoms
Title
BAI: anxiety symptoms
Title
WHOQL-Bref: quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Jane Parent
Phone
(514) 251-4000
Ext
3574
Email
sparent.hlhl@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Cindy Beaudoin
Phone
(514) 251-4000
Ext
3574
Email
beaudoincindy@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Guay
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'étude sur le Trauma
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1N 3V2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane Guay, Ph.D.
Phone
(514) 251-4000
Ext
3084
Email
stephane.guay@umontreal.ca
First Name & Middle Initial & Last Name & Degree
André Marchand, Ph.D.
Phone
(514) 251-4000
Ext
2510
Email
amarchand.hlhl@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Stéphane Guay, Ph.D.
First Name & Middle Initial & Last Name & Degree
André Marchand, Ph.D.
First Name & Middle Initial & Last Name & Degree
Pierre Landry, M.D.

12. IPD Sharing Statement

Learn more about this trial

RCT of CBT Combined With D-Cycloserine for Treating PTSD

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