CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 43 enrolled
Drug / intervention
Fluoxetine +1 moredrug
Likely dose
Fluoxetine 10–80 mg orally daily, fixed/flexible dosing adjusted by weight and side effectsAI-extracted
Key inclusion· 3
  • ✓Male or female children and adolescents aged 16 years or younger
  • ✓Current BDD or delusional variant of BDD present for at least 6 months prior to enrollment
  • ✓Ability to communicate meaningfully with investigators and competent to provide written assent
Key exclusion· 4
  • ✕Schizophrenia or Bipolar Disorder
  • ✕Recent suicide attempt or suicidal ideations warranting hospitalization
  • ✕Previous allergic reaction to fluoxetine
  • ✕History of seizure disorder

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00245635
NCT00245635Phase 4Completed
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Fluoxetine in Pediatric Body Dysmorphic Disorder

Montefiore Medical Center·interventional·Posted Oct 28, 2005·Updated Apr 27, 2018

In Brief

A Phase 4 clinical trial evaluating Fluoxetine and Placebo for Body Dysmorphic Disorder. Completed, enrolled 43 participants across 2 sites.

Detailed Summary

This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBody Dysmorphic Disorder
CountriesUnited States
CollaboratorsFood and Drug Administration (FDA)

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 28, 2005
Enrollment StartNov 1, 2004
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 20.7 years ago

Interventions

Fluoxetinedrug

Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score.

Placebodrug

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.