NCT00182000

Brief Summary

This study will assess the effectiveness of Seromycin (D-cycloserine) in enhancing the positive effects of behavior therapy for people with Obsessive-Compulsive Disorder (OCD).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for phase_3

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

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

July 6, 2012

Completed
Last Updated

July 16, 2012

Status Verified

July 1, 2012

Enrollment Period

4.2 years

First QC Date

September 13, 2005

Results QC Date

May 1, 2012

Last Update Submit

July 10, 2012

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD

Outcome Measures

Primary Outcomes (1)

  • Yale-Brown Obsessive Compulsive Scale (YBOCS)

    A clinician-rated measure of obsessive-compulsive disorder severity. Each item is scored on a 0 to 4 range. Total scores are obtained by summing items 1-10 and thus range from 0 to 40 with higher scores indicating greater symptom severity. Results posted below are from the post-treatment evaluation (after 10 treatment sessions).

    Post-treatment (week 5)

Secondary Outcomes (6)

  • Clinical Global Impressions Scale (CGI)

    Post-treatment (week 5)

  • Beck Depression Inventory (BDI)

    Post-treatment (week 5)

  • Beck Anxiety Inventory (BAI)

    Post-treatment (week 5)

  • Obsessional Beliefs Questionnaire (OBQ)

    Post-treatment (week 5)

  • Short-Form Health Survey (SF-36)

    Post-treatment (week 5)

  • +1 more secondary outcomes

Study Arms (2)

Seromycin

ACTIVE COMPARATOR
Drug: seromycinBehavioral: Behavior Therapy

Placebo

PLACEBO COMPARATOR
Behavioral: Behavior Therapy

Interventions

seromycinDRUG

100mg tablet administered 1 hour prior to each therapy session

Also known as: D-Cycloserine
Seromycin
Behavior TherapyBEHAVIORAL

10 weekly hour-long behavior therapy sessions

PlaceboSeromycin

Eligibility Criteria

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

You may qualify if:

  • Structured Clinical Interview for DSM-IV (SCID) diagnosis of Obsessive Compulsive Disorder
  • Score of greater than 16 on the Yale-Brown Obsessive Compulsive Scale
  • Negative urinary beta-Human Chorionic Gonadotropin (hCG) test

You may not qualify if:

  • Currently taking or have taken an unstable dose of psychotropic medications within 2 months prior to enrollment
  • Currently taking medications that may interfere with the study medication
  • History of seizure disorder or other serious medical illnesses (e.g., cardiovascular, liver, kidney, respiratory, endocrine, neurologic, or blood-related disease)
  • Current diagnosis of tuberculosis
  • Other psychiatric diagnoses (e.g., alcohol dependence, bipolar disorder, psychosis, organic mental disorder, or development disorder) that are of greater concern than the obsessive-compulsive disorder diagnosis
  • Currently taking medications that may lower seizure threshold (e.g., including clozapine, pethidine, and the following antibiotics in high dosage: penicillins, cephalosporins, amphotericin, and imipenem)
  • Poses a serious suicidal or homicidal threat
  • Currently undergoing psychotherapy
  • Failure to benefit from ten or more sessions of previous Exposure and Response Prevention (ERP) treatment
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

CycloserineBehavior Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Sabine Wilhelm, PhD
Organization
Massachusetts General Hospital
swilhelm@partners.org
6177246146

Study Officials

  • Sabine Wilhelm, Ph.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

November 1, 2003

Primary Completion

January 1, 2008

Last Updated

July 16, 2012

Results First Posted

July 6, 2012

Record last verified: 2012-07