Fluoxetine in Pediatric Body Dysmorphic Disorder (FDA BDD)
|ClinicalTrials.gov Identifier: NCT00245635|
Recruitment Status : Completed
First Posted : October 28, 2005
Results First Posted : June 29, 2015
Last Update Posted : July 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Body Dysmorphic Disorder||Drug: Fluoxetine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Fluoxetine in Pediatric Body Dysmorphic Disorder|
|Study Start Date :||November 2004|
|Primary Completion Date :||April 2012|
|Study Completion Date :||April 2012|
Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.
Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score.
Other Name: Prozac
Placebo Comparator: 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 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245635
|United States, New York|
|Montefiore Medical Center, Albert Einstein College of Medicine|
|Bronx, New York, United States, 10467|
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Eric Hollander, MD||Montefiore Medical Center, Albert Einstein College of Medicine|