Body Dysmorphic Disorder
Conditions
Keywords
Body Dysmorphic Disorder, BDD, BDD treatment, delusionality variant, OCD
Brief summary
This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify.
Detailed description
BDD usually begins in childhood or adolescence, but its treatment in pediatric populations has not been investigated. Recent data suggests that adults with BDD may respond to serotonin reuptake inhibitors (SRIs) such as fluoxetine (Prozac). Preliminary findings from case reports suggest that SRIs may also be effective in the treatment of BDD in children and adolescents. This study is the first large-scale, double-blind, placebo-controlled medication trial of fluoxetine for children and adolescents with BDD. Participants should be aged 16 or younger. Participation in this trial will last approximately 14 weeks.
Interventions
DRUGFluoxetine
Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score.
DRUGPlacebo
Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score.
Sponsors
Food and Drug Administration (FDA)
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
* Male or female children and adolescents aged 16 and younger * BDD or its delusional variant present currently and for at least 6 months prior to the study * Ability to communicate meaningfully with the investigators and competent to provide written assent
Exclusion criteria
* Presence of Schizophrenia or Bipolar Disorder * Recent suicide attempt or suicidal ideations that warrant hospitalizations * Previous allergic reaction to fluoxetine * History of a seizure disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Score on the BDD-Y-BOCS Scale | Baseline compared to the study endpoint (week 12) [two time points] | To assess the change in total score on the Body Dysmorphic Disorder-Yale-Brown Obsessive Compulsive Scale (BDD-Y-BOCS) from baseline (visit 0) to endpoint (week 12). This is a 12-item scale that assesses obsessions and compulsions related to the patient's BDD. Each item's score ranges from 0 to 4, with a total possible score of 48 on the full assessment. Scores of 0 indicate no impairment, while scores of 4 indicate maximum impairment. Thus higher scores are considered to be a worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluoxetine Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.
Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score. | 25 |
| Placebo Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.
Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score. | 18 |
| Total | 43 |
Baseline characteristics
| Characteristic | Fluoxetine | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 15.04 years | 14.88 years | 14.96 years |
| BDD-Y-BOCS | 30.84 units on a scale STANDARD_DEVIATION 4.2 | 35.16 units on a scale STANDARD_DEVIATION 5.1 | 32.65 units on a scale STANDARD_DEVIATION 5.02 |
| Region of Enrollment United States | 25 participants | 18 participants | 43 participants |
| Sex: Female, Male Female | 18 Participants | 15 Participants | 33 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 25 | 3 / 18 |
| serious Total, serious adverse events | 1 / 25 | 0 / 18 |
Outcome results
Primary
Change in Total Score on the BDD-Y-BOCS Scale
To assess the change in total score on the Body Dysmorphic Disorder-Yale-Brown Obsessive Compulsive Scale (BDD-Y-BOCS) from baseline (visit 0) to endpoint (week 12). This is a 12-item scale that assesses obsessions and compulsions related to the patient's BDD. Each item's score ranges from 0 to 4, with a total possible score of 48 on the full assessment. Scores of 0 indicate no impairment, while scores of 4 indicate maximum impairment. Thus higher scores are considered to be a worse outcome.
Time frame: Baseline compared to the study endpoint (week 12) [two time points]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoxetine | Change in Total Score on the BDD-Y-BOCS Scale | -12.27 units on a scale | Standard Deviation 11.78 |
| Placebo | Change in Total Score on the BDD-Y-BOCS Scale | -9.53 units on a scale | Standard Deviation 12.07 |