NCT00126282

Brief Summary

This study examines the efficacy of the medication D-Cycloserine in the reduction of obsessions and compulsions in individuals with obsessive-compulsive disorder (OCD). All study participants will receive Exposure and Response Prevention, a common form of behavior therapy for individuals with OCD. Half (50%) of the participants will be randomly assigned to the placebo condition and the other half (50%) will be randomly assigned to receive D-Cycloserine. Because all participants will receive 10 sessions of behavior therapy, all participants are expected to improve from this treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2005

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 29, 2009

Status Verified

May 1, 2008

First QC Date

August 2, 2005

Last Update Submit

July 27, 2009

Conditions

Obsessive-Compulsive Disorder

Keywords

obsessive-compulsive disorderbehavior therapyD-Cycloserinemedicationtreatment trialplacebo-controlleddouble-blindrandomized

Outcome Measures

Primary Outcomes (1)

  • significant reduction of OCD symptoms after the completion of treatment

Secondary Outcomes (1)

  • significant reduction of depressive symptoms after the completion of treatment

Interventions

behavior therapyBEHAVIORAL
D-CycloserineDRUG

Eligibility Criteria

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

You may qualify if:

  • Meets diagnosis for obsessive-compulsive disorder

You may not qualify if:

  • History of psychotic disorders
  • History of neurological disorders
  • History of bipolar disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Anxiety Disorders Center, The Institute of Living

Hartford, Connecticut, 06106, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Behavior TherapyCycloserine

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesIsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOxazolidinonesOxazolesSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Sabine Wilhelm, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • David Tolin, PhD

    Hartford Institute of Living

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2005

First Posted

August 3, 2005

Study Start

December 1, 2003

Study Completion

December 1, 2007

Last Updated

July 29, 2009

Record last verified: 2008-05

Locations

US(2)