Obsessive-Compulsive DisorderNCT00126282
A Medication Trial Combined With Behavior Therapy for Individuals With Obsessive-compulsive Disorder
A study testing behavior therapy and D-Cycloserine in people with Obsessive-Compulsive Disorder, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- behavior therapy and D-Cycloserine
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2003to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets diagnosis for obsessive-compulsive disorder
Who cannot join
- History of psychotic disorders
- History of neurological disorders
- History of bipolar disorders
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Anxiety Disorders Center, The Institute of Living
Hartford, Connecticut, 06106
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Medication Trial With D-Cycloserine for Individuals With Obsessive-compulsive Disorder Currently Receiving Behavior Therapy
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.
Read the detailed description
The study consists of Behavior Therapy (Exposure and Response Prevention; ERP) for OCD. Specifically, it involves exposure to anxiety-provoking situations and response-prevention of any rituals. ERP has shown to be effective for many individuals with OCD.
All assessments and treatment sessions are at no cost to the patients. 50% of the patients will randomly be assigned to the D-Cycloserine (DCS) condition, and 50% of the patients will be assigned to a placebo condition. D-Cycloserine is FDA-approved for the treatment of Tuberculosis. However, recent research in other anxiety disorders has shown that D-Cycloserine plus Behavior Therapy is more effective than Behavior Therapy alone.
This treatment study has two active conditions. That is, all patients will receive Behavior Therapy and we do expect that everybody will improve from this treatment. However, it may be that those patients in the DCS condition will improve somewhat more than those in the placebo condition.
The treatment will be structured with homework and repeated assessments every 4 weeks. Assessments are extremely important as they guide the treatment and provide the study investigators necessary information about the treatment. The treatment consists of 10 sessions (twice a week) plus post-treatment and follow-up assessments at 1 and 6 months.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- behavior therapy, D-Cycloserine
- Keywords
- obsessive-compulsive disorder, behavior therapy, D-Cycloserine, medication, treatment trial, placebo-controlled, double-blind, randomized
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavior therapyBehavioural
D-CycloserineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
significant reduction of OCD symptoms after the completion of treatment
Secondary outcomes (1)
significant reduction of depressive symptoms after the completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2005 (estimated)
- Study startDec 2003
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sabine Wilhelm, PhD, Principal investigator, Massachusetts General HospitalDavid Tolin, PhD, Principal investigator, Hartford Institute of Living
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126282
- Sponsor's protocol ID
- 2003-P-0001325
- Status last verified
- May 2008
- First submitted
- 2 Aug 2005
- Last updated
- 29 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Medication Trial With D-Cycloserine for Individuals With Obsessive-compulsive Disorder Currently Receiving Behavior Therapy
- ClinicalTrials.gov ID
- NCT00126282
- Acronym / sponsor ID
- 2003-P-0001325
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- obsessive-compulsive disorder, behavior therapy, D-Cycloserine, medication, treatment trial, placebo-controlled, double-blind, randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2003
- Study completion
- Dec 2007 (actual)
- First posted
- 3 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study consists of Behavior Therapy (Exposure and Response Prevention; ERP) for OCD. Specifically, it involves exposure to anxiety-provoking situations and response-prevention of any rituals. ERP has shown to be effective for many individuals with OCD.
All assessments and treatment sessions are at no cost to the patients. 50% of the patients will randomly be assigned to the D-Cycloserine (DCS) condition, and 50% of the patients will be assigned to a placebo condition. D-Cycloserine is FDA-approved for the treatment of Tuberculosis. However, recent research in other anxiety disorders has shown that D-Cycloserine plus Behavior Therapy is more effective than Behavior Therapy alone.
This treatment study has two active conditions. That is, all patients will receive Behavior Therapy and we do expect that everybody will improve from this treatment. However, it may be that those patients in the DCS condition will improve somewhat more than those in the placebo condition.
The treatment will be structured with homework and repeated assessments every 4 weeks. Assessments are extremely important as they guide the treatment and provide the study investigators necessary information about the treatment. The treatment consists of 10 sessions (twice a week) plus post-treatment and follow-up assessments at 1 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meets diagnosis for obsessive-compulsive disorder
Key exclusion criteria (3 listed)
- History of psychotic disorders
- History of neurological disorders
- History of bipolar disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavior therapy | Behavioural | – |
| D-Cycloserine | Drug | – |
Primary outcome
significant reduction of OCD symptoms after the completion of treatment
1 secondary outcome
significant reduction of depressive symptoms after the completion of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Wilhelm, PhD principal investigator
Massachusetts General Hospital
David Tolin, PhD principal investigator
Hartford Institute of Living
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavior therapy and D-Cycloserine in people with Obsessive-Compulsive Disorder, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
significant reduction of OCD symptoms after the completion of treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2009.