NCT00452231

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

March 27, 2007

Status Verified

March 1, 2007

First QC Date

March 26, 2007

Last Update Submit

March 26, 2007

Conditions

Post-Traumatic Stress Disorder

Keywords

Post-traumatic Stress DisorderCognitive-Behavioral Therapy

Outcome Measures

Primary Outcomes (3)

  • Clinician-administered measures collected at initial assessment, post-treatment and six-months follow-up:

  • CAPS: PTSD symptoms

  • SCID: AXIS I disorders

Secondary Outcomes (4)

  • 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

Interventions

D-cycloserineDRUG
Cognitive-Behavioral TherapyBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Substance abuse
  • Psychotic episodes (past or current)
  • Bipolar disorder
  • Organic caused mental disorder
  • Intellectual deficiency
  • Pregnant or breast-feeding woman
  • Épilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'étude sur le Trauma

Montreal, Quebec, H1N 3V2, Canada

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

CycloserineCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOxazolidinonesOxazolesSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and ProteinsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Stéphane Guay

    Université de Montréal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Jane Parent

CONTACT

(514) 251-4000sparent.hlhl@ssss.gouv.qc.ca

Cindy Beaudoin

CONTACT

(514) 251-4000beaudoincindy@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2007

First Posted

March 27, 2007

Study Start

February 1, 2007

Study Completion

July 1, 2008

Last Updated

March 27, 2007

Record last verified: 2007-03

Locations

CA(1)