Fluoxetine in Pediatric Body Dysmorphic Disorder (FDA BDD)
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|ClinicalTrials.gov Identifier: NCT00245635|
Recruitment Status : Completed
First Posted : October 28, 2005
Results First Posted : June 29, 2015
Last Update Posted : April 27, 2018
|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|
|Actual Primary Completion Date :||April 2012|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|