An Early Phase 1 interventional study of d-cycloserine and Placebo in Body Dysmorphic Disorder, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-18.
Sponsored by Massachusetts General Hospital · Early Phase 1, Interventional, and Treatment
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.
59 studies on the registry are indexed under Body Dysmorphic Disorders; 12 are open to participants now.
This study's enrollment of 68 is above the median of 50 across 45 interventional studies indexed under Body Dysmorphic Disorders.
Browse Body Dysmorphic Disorders studies →Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Exclusion Criteria:
100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Drug: d-cycloserine
Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Drug: Placebo
100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Also known as: seromycin
Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Also known as: sugar pill
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.
Time frame: 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.
Time frame: Mid-treatment (week 6)
| Milestone | D-cycloserine-augmented CBT | Placebo-augmented CBT |
|---|---|---|
| Started | 14 | 14 |
| Completed | 11 | 13 |
| Not completed | 3 | 1 |
| Withdrew: Withdrawal by subject | 3 | 1 |
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.
| units on a scale | D-cycloserine | Placebo |
|---|---|---|
| Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) | 19.64 ± 6.8 | 18.77 ± 10.03 |
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.
| units on a scale | D-cycloserine | Placebo |
|---|---|---|
| Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) | 21.75 ± 5.34 | 20.85 ± 8.9 |
Collected over Adverse event data was collected at pretreatment, mid-treatment, post-treatment and at 1- and 6- month follow-up visits.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| D-cycloserine-augmented CBT | 0/14 (0%) | 0/14 (0%) | 1/14 (7.1%) |
| Placebo-augmented CBT | 0/14 (0%) | 0/14 (0%) | 3/14 (21.4%) |
| Event | D-cycloserine-augmented CBT | Placebo-augmented CBT |
|---|---|---|
| Feeling drowsy or sleepyNervous system disorders | 0/14 | 2/14 |
| Depressive symptomsPsychiatric disorders | 1/14 | 1/14 |
| Stress fracture in both armsGeneral disorders | 1/14 | 0/14 |
| Tendonitis in kneeMusculoskeletal and connective tissue disorders | 1/14 | 0/14 |
| Went to dermatologist for acne and started medicationSkin and subcutaneous tissue disorders | 1/14 | 0/14 |
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.
| Age, Continuous(years) | D-cycloserine | Placebo | Total |
|---|---|---|---|
| Mean | 23.92 ± 5.74 | 29.07 ± 11.04 | 26.69 ± 9.46 |
| Sex: Female, Male(Participants) | D-cycloserine | Placebo | Total |
|---|---|---|---|
| Female | 5 | 12 | 17 |
| Male | 7 | 2 | 9 |
| Race (NIH/OMB)(Participants) | D-cycloserine | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 11 | 11 | 22 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 1 | 1 |
| BDD-YBOCS(units on a scale) | D-cycloserine | Placebo | Total |
|---|---|---|---|
| Mean | 31.75 ± 5.03 | 30.36 ± 4.45 | 31 ± 4.68 |
Documents are hosted by the registry — open the source record to download them.
The record gives a start of Nov 2008, a primary completion of Dec 2017 and a completion of Aug 2018. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2019, 1 year 3 months after primary completion.
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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cycloserine
Massachusetts General Hospital →