Phase 4
N=43
Fluoxetine in Pediatric Body Dysmorphic Disorder
Body Dysmorphic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00245635 ↗Enrolled (actual)
43
Serious AEs
2.3%
Results posted
Jun 2015
Primary outcome: Primary: Change in Total Score on the BDD-Y-BOCS Scale — -12.27; -9.53 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fluoxetine (Drug); Placebo (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Score on the BDD-Y-BOCS Scale |
-12.27; -9.53 | — |
Summary
This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00245635). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.