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| Name | Class |
|---|---|
| Hartford Hospital | OTHER |
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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seromycin | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| seromycin | Drug | 100mg tablet administered 1 hour prior to each therapy session |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impressions Scale (CGI) | Post-treatment (week 5) | |
| Beck Depression Inventory (BDI) | Post-treatment (week 5) | |
| Beck Anxiety Inventory (BAI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabine Wilhelm, Ph.D. | Massachusetts General Hospital | Principal Investigator |
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33 participants enrolled in the study. However, 4 participants decided not to participate in between consenting and starting treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Seromycin | 10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin |
| FG001 | Placebo | 10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Seromycin | 10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin |
| BG001 | Placebo | 10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Thirty-three participants were enrolled. Four participants decided not to participate in between enrolling and beginning treatment. Six participants withdrew from the study before the mid-treatment evaluation; 1 participant withdrew from the study after the mid-treatment evaluation, and this participant's data was carried forward. | Posted | Mean | Standard Deviation | units on a scale | Post-treatment (week 5) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Seromycin | 10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sabine Wilhelm, PhD | Massachusetts General Hospital | 6177246146 | swilhelm@partners.org |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003523 | Cycloserine |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Behavior Therapy | Behavioral | 10 weekly hour-long behavior therapy sessions |
|
| Post-treatment (week 5) |
| Obsessional Beliefs Questionnaire (OBQ) | Post-treatment (week 5) |
| Short-Form Health Survey (SF-36) | Post-treatment (week 5) |
| Disability Inventory | Post-treatment (week 5) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | 10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo |
|
|
| Secondary | Clinical Global Impressions Scale (CGI) | Not Posted | Post-treatment (week 5) |
| Secondary | Beck Depression Inventory (BDI) | Not Posted | Post-treatment (week 5) |
| Secondary | Beck Anxiety Inventory (BAI) | Not Posted | Post-treatment (week 5) |
| Secondary | Obsessional Beliefs Questionnaire (OBQ) | Not Posted | Post-treatment (week 5) |
| Secondary | Short-Form Health Survey (SF-36) | Not Posted | Post-treatment (week 5) |
| Secondary | Disability Inventory | Not Posted | Post-treatment (week 5) |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Placebo | 10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo | 0 | 15 | 0 | 15 |
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| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |