Obsessive-Compulsive DisorderPhase 3NCT00182000
Effectiveness of D-Cycloserine as an Aid to Enhance Learning for Individuals With OCD Receiving Behavior Therapy
A Phase 3 study testing seromycin and Behavior Therapy in people with Obsessive-Compulsive Disorder, run by Massachusetts General Hospital.
Trial 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). 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?
- seromycin and Behavior Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Jan 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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)
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- 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
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Medication Trial With D-Cycloserine for Individuals With OCD Currently Receiving Behavior Therapy
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).
Read the detailed description
We hope to enroll 50 subjects in a double-blind, placebo-controlled study of D-cycloserine augmentation of behavior therapy for Obsessive-Compulsive Disorder. All subjects will undergo a pre-treatment assessment, and then be randomly assigned to receive Seromycin (100 mg) or placebo one-hour before each of 10 therapy sessions. Subjects will then come in for a treatment planning session and the behavior therapy sessions delivered twice weekly for 5 weeks. Comprehensive assessments of obsessive-compulsive symptoms, mood state, and cognitions will be given at baseline, after 5 treatment sessions, after 10 sessions and 1 month and 6 months post-treatment.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- seromycin, Behavior Therapy
- Keywords
- OCD
- 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.
seromycinDrug
Also called D-Cycloserine
100mg tablet administered 1 hour prior to each therapy session
Behavior TherapyBehavioural
10 weekly hour-long behavior therapy sessions
| Study group | Role | What they receive |
|---|---|---|
| Seromycin | Active comparator | Not described Receives: Drug: seromycin; Behavioral: Behavior Therapy |
| Placebo | Placebo comparator | Not described Receives: Behavioral: Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Post-treatment (week 5)
Secondary outcomes (6)
Clinical Global Impressions Scale (CGI)
Measured: Post-treatment (week 5)
Beck Depression Inventory (BDI)
Measured: Post-treatment (week 5)
Beck Anxiety Inventory (BAI)
Measured: Post-treatment (week 5)
Obsessional Beliefs Questionnaire (OBQ)
Measured: Post-treatment (week 5)
Short-Form Health Survey (SF-36)
Measured: Post-treatment (week 5)
Disability Inventory
Measured: Post-treatment (week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2003
- Primary completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hartford Hospital
- Responsible party
- Principal investigator, Sabine Wilhelm, Massachusetts General Hospital
- Investigators
- Sabine Wilhelm, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182000
- Sponsor's protocol ID
- 2003-P-001325
- Status last verified
- Jul 2012
- First submitted
- 13 Sep 2005
- Last updated
- 16 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. 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 OCD Currently Receiving Behavior Therapy
- ClinicalTrials.gov ID
- NCT00182000
- Acronym / sponsor ID
- 2003-P-001325
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Hartford Hospital
- Study start
- Nov 2003
- Primary completion
- Jan 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 6 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
We hope to enroll 50 subjects in a double-blind, placebo-controlled study of D-cycloserine augmentation of behavior therapy for Obsessive-Compulsive Disorder. All subjects will undergo a pre-treatment assessment, and then be randomly assigned to receive Seromycin (100 mg) or placebo one-hour before each of 10 therapy sessions. Subjects will then come in for a treatment planning session and the behavior therapy sessions delivered twice weekly for 5 weeks. Comprehensive assessments of obsessive-compulsive symptoms, mood state, and cognitions will be given at baseline, after 5 treatment sessions, after 10 sessions and 1 month and 6 months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seromycin | Active comparator | Drug: seromycin, Behavioral: Behavior Therapy |
| Placebo | Placebo comparator | Behavioral: Behavior Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| seromycinAlso: D-Cycloserine100mg tablet administered 1 hour prior to each therapy session | Drug | Seromycin |
| Behavior Therapy10 weekly hour-long behavior therapy sessions | Behavioural | Placebo, Seromycin |
Primary outcome
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time frame: Post-treatment (week 5)
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).
6 secondary outcomes
Clinical Global Impressions Scale (CGI)
Time frame: Post-treatment (week 5)
Beck Depression Inventory (BDI)
Time frame: Post-treatment (week 5)
Beck Anxiety Inventory (BAI)
Time frame: Post-treatment (week 5)
Obsessional Beliefs Questionnaire (OBQ)
Time frame: Post-treatment (week 5)
Short-Form Health Survey (SF-36)
Time frame: Post-treatment (week 5)
Disability Inventory
Time frame: Post-treatment (week 5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, Ph.D. principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing seromycin and Behavior Therapy in people with Obsessive-Compulsive Disorder, run by Massachusetts General Hospital.
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 3 inclusion and 10 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 16 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Yale-Brown Obsessive Compulsive Scale (YBOCS) (time frame: Post-treatment (week 5)). 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 16 Jul 2012.