Body Dysmorphic Disorder
Conditions
Brief summary
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.
Interventions
DRUGd-cycloserine
100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
DRUGPlacebo
Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Primary diagnosis of Body Dysmorphic Disorder as determined by DSM-IV criteria * BDD Yale-Brown Obsessive Compulsive Scale score greater than or equal to 24 * Females of childbearing potential must have a negative urinary beta-HCG test * Subjects currently taking psychotropic medication must be on a stable does for at least two months prior to initiating study procedures
Exclusion criteria
* Pregnant or breastfeeding women will be excluded * People taking medications that may interfere with DCS * History of seizure disorder or other serious medical illnesses such as cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease * Comorbid psychiatric diagnoses (alcohol dependence, bipolar disorder, psychosis, borderline personality disorder, organic mental disorder, or development disorder). If subjects have any other comorbid disorder, the BDD symptoms have to be the primary concern. * Persons taking medications that may lower seizure threshold, including clozapine, pethidine, and the following antibiotics in high dosage: penicillins, cephalosporins, amphotericin, and imipenem * Those deemed to pose a serious suicidal or homicidal threat will be excluded * Current psychotherapy or failure to benefit from ten or more sessions of previous ERP treatment is a rule-out
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) | Endpoint (post-treatment, week 11) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 14 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | D-cycloserine | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 23.92 years STANDARD_DEVIATION 5.74 | 29.07 years STANDARD_DEVIATION 11.04 | 26.69 years STANDARD_DEVIATION 9.46 |
| BDD-YBOCS | 31.75 units on a scale STANDARD_DEVIATION 5.03 | 30.36 units on a scale STANDARD_DEVIATION 4.45 | 31 units on a scale STANDARD_DEVIATION 4.68 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Female | 5 Participants | 12 Participants | 17 Participants |
| Sex: Female, Male Male | 7 Participants | 2 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 1 / 14 | 3 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
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.
Time frame: Endpoint (post-treatment, week 11)
Population: BDD-YBOCS was a clinician-administered measure administered to patients with body dysmorphic disorder.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| D-cycloserine | Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) | 19.64 units on a scale | Standard Deviation 6.8 |
| Placebo | Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) | 18.77 units on a scale | Standard Deviation 10.03 |
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.
Time frame: Mid-treatment (week 6)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| D-cycloserine | Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) | 21.75 units on a scale | Standard Deviation 5.34 |
| Placebo | Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) | 20.85 units on a scale | Standard Deviation 8.9 |