A Phase 4 interventional study of Fluoxetine and Placebo in Body Dysmorphic Disorder, sponsored by Montefiore Medical Center. Completed at 2 sites in United States. Open to participants aged Up to 16 Years. Per ClinicalTrials.gov, last updated 2018-04-27.
Sponsored by Montefiore Medical Center · Phase 4, Interventional, and Treatment
This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify.
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.
56 studies on the registry are indexed under Body Dysmorphic Disorders; 11 are open to participants now.
This study's enrollment of 43 is below the median of 52 across 44 interventional studies indexed under Body Dysmorphic Disorders.
Browse Body Dysmorphic Disorders studies →Montefiore Medical Center is the lead sponsor of 416 studies on the registry; 69 are open to participants now.
Of its 87 completed or terminated interventional studies of FDA-regulated products, 76 (87%) have results posted.
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Exclusion Criteria:
Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.
Drug: Fluoxetine
Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.
Drug: Placebo
Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score.
Also known as: Prozac
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.
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]
| Milestone | Fluoxetine | Placebo |
|---|---|---|
| Started | 25 | 18 |
| Completed | 25 | 18 |
| Not completed | 0 | 0 |
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.
| units on a scale | Fluoxetine | Placebo |
|---|---|---|
| Change in Total Score on the BDD-Y-BOCS Scale | -12.27 ± 11.78 | -9.53 ± 12.07 |
Collected over Adverse Event data was collected throughout the course of the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fluoxetine | — | 1/25 (4%) | 2/25 (8%) |
| Placebo | — | 0/18 (0%) | 3/18 (16.7%) |
| Event | Fluoxetine | Placebo |
|---|---|---|
| Suicidal BehaviorPsychiatric disorders | 1/25 | 0/18 |
| Event | Fluoxetine | Placebo |
|---|---|---|
| DrowsinessGeneral disorders | 0/25 | 3/18 |
| NauseaGastrointestinal disorders | 1/25 | 2/18 |
| Weight LossMetabolism and nutrition disorders | 2/25 | 2/18 |
| Decreased AppetiteMetabolism and nutrition disorders | 1/25 | 2/18 |
| Agitated/RestlessnessPsychiatric disorders | 1/25 | 2/18 |
| HeadacheGeneral disorders | 1/25 | 2/18 |
| Light hurts eyesEye disorders | 0/25 | 2/18 |
| Feeling tensePsychiatric disorders | 0/25 | 2/18 |
| Ears ringingEar and labyrinth disorders | 0/25 | 2/18 |
| DizzinessNervous system disorders | 0/25 | 2/18 |
| Age, Continuous(years) | Fluoxetine | Placebo | Total |
|---|---|---|---|
| Mean | 15.04 (9 to 18) | 14.88 (10 to 18) | 14.96 (9 to 18) |
| Sex: Female, Male(Participants) | Fluoxetine | Placebo | Total |
|---|---|---|---|
| Female | 18 | 15 | 33 |
| Male | 7 | 3 | 10 |
| Region of Enrollment(participants) | Fluoxetine | Placebo | Total |
|---|---|---|---|
| United States | 25 | 18 | 43 |
| BDD-Y-BOCS(units on a scale) | Fluoxetine | Placebo | Total |
|---|---|---|---|
| Mean | 30.84 ± 4.2 | 35.16 ± 5.10 | 32.65 ± 5.02 |
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fluoxetine