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The purpose of the study is to conduct a double-blind, placebo-controlled study of D-cycloserine (DCS) augmentation of behavior therapy in individuals with Body Dysmorphic Disorder (BDD). Specifically, we intend to randomize 50 individuals with BDD to receive either DCS (n = 25) or placebo (n = 25) one hour prior to 8 of 10 behavior therapy sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-cycloserine | Active Comparator | 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. |
|
| Placebo | Placebo Comparator | Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| d-cycloserine | Drug | 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) | The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess BDD symptoms at baseline and endpoint. | Endpoint (post-treatment, week 11) |
| Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) | The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess BDD symptoms at baseline and endpoint. | Mid-treatment (week 6) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabine Wilhelm, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| Label | URL |
|---|---|
| Mass General Hospital BDD clinic website | View source |
| OCD and Related Disorders Clinic at MGH | View source |
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68 participants consented and screened. Of those, 28 were deemed eligible to participate and randomized to a condition. The remaining 40 participants were excluded for the following reasons: Did not meet criteria (n= 30) Declined to participate (n= 4) Did not show (n= 3) Other (n= 3)
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| ID | Title | Description |
|---|---|---|
| FG000 | D-cycloserine-augmented CBT | 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. d-cycloserine: 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. |
| FG001 | Placebo-augmented CBT | Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. Placebo: Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants included in modified intent-to-treat (ITT) analyses were 26 adults who completed at least one treatment session in their randomized condition [CBT plus DCS (n = 12); CBT plus placebo (n = 14)]. Note that 2 participants in CBT plus DCS did not complete any sessions in their randomized condition and were excluded from analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | D-cycloserine | 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. d-cycloserine: 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) | The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess BDD symptoms at baseline and endpoint. | BDD-YBOCS was a clinician-administered measure administered to patients with body dysmorphic disorder. | Posted | Mean | Standard Deviation | units on a scale | Endpoint (post-treatment, week 11) |
|
Adverse event data was collected at pretreatment, mid-treatment, post-treatment and at 1- and 6- month follow-up visits.
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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 | D-cycloserine-augmented CBT | 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. d-cycloserine: 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Feeling drowsy or sleepy | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hilary Weingarden | Massachusetts General Hospital | 617-643-6206 | hilary_weingarden@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2016 | Jun 6, 2019 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D057215 | Body Dysmorphic Disorders |
| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003523 | Cycloserine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. |
|
|
Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. Placebo: Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BDD-YBOCS | The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess change in BDD symptoms from baseline to endpoint. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Placebo | Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. Placebo: Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. |
|
|
| Primary | Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) | The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess BDD symptoms at baseline and endpoint. | Posted | Mean | Standard Deviation | units on a scale | Mid-treatment (week 6) |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 1 |
| 14 |
| EG001 | Placebo-augmented CBT | Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. Placebo: Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. | 0 | 14 | 0 | 14 | 3 | 14 |
| Depressive symptoms | Psychiatric disorders | Systematic Assessment | One patient experienced a major depressive episode during the follow-up period. Another patient had an increase in depressive symptoms and suicidal thoughts (no plan) during follow-up. |
|
| Stress fracture in both arms | General disorders | Systematic Assessment |
|
| Tendonitis in knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Went to dermatologist for acne and started medication | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002241 | Carbohydrates |