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Trial record 7 of 12 for:    "Somatoform Disorder" | "Serotonin Agents"

Fluoxetine in Pediatric Body Dysmorphic Disorder (FDA BDD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00245635
Recruitment Status : Completed
First Posted : October 28, 2005
Results First Posted : June 29, 2015
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Eric Hollander, Montefiore Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Body Dysmorphic Disorder
Interventions Drug: Fluoxetine
Drug: Placebo
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fluoxetine Placebo
Hide Arm/Group Description

Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.

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

Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.

Placebo: 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.

Period Title: Overall Study
Started 25 18
Completed 25 18
Not Completed 0 0
Arm/Group Title Fluoxetine Placebo Total
Hide Arm/Group Description

Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.

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

Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.

Placebo: 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.

Total of all reporting groups
Overall Number of Baseline Participants 25 18 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants 18 participants 43 participants
15.04
(9 to 18)
14.88
(10 to 18)
14.96
(9 to 18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 18 participants 43 participants
Female
18
  72.0%
15
  83.3%
33
  76.7%
Male
7
  28.0%
3
  16.7%
10
  23.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 18 participants 43 participants
25 18 43
BDD-Y-BOCS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 25 participants 18 participants 43 participants
30.84  (4.2) 35.16  (5.10) 32.65  (5.02)
[1]
Measure Description: Total scores at Baseline on the Body Dysmorphic Disorder-Yale-Brown Obsessive Compulsive Scale (BDD-Y-BOCS)
1.Primary Outcome
Title Change in Total Score on the BDD-Y-BOCS Scale
Hide Description 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]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoxetine Placebo
Hide Arm/Group Description:

Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.

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

Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.

Placebo: 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.

Overall Number of Participants Analyzed 25 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-12.27  (11.78) -9.53  (12.07)
Time Frame Adverse Event data was collected throughout the course of the study.
Adverse Event Reporting Description Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
 
Arm/Group Title Fluoxetine Placebo
Hide Arm/Group Description

Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.

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

Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.

Placebo: 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.

All-Cause Mortality
Fluoxetine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluoxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/25 (4.00%)      0/18 (0.00%)    
Psychiatric disorders     
Suicidal Behavior  [1]  1/25 (4.00%)  1 0/18 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Suicidal behavior was seen in one subject and had a possible relationship to study drug, and subject was seen in a partial hospitalization setting. This was reported to the IRB, FDA and DSMB.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fluoxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/25 (8.00%)      3/18 (16.67%)    
Cardiac disorders     
Heart Pounding/Racing   0/25 (0.00%)  0 1/18 (5.56%)  2
Ear and labyrinth disorders     
Ears ringing   0/25 (0.00%)  0 2/18 (11.11%)  2
Endocrine disorders     
Sweating   1/25 (4.00%)  1 1/18 (5.56%)  1
Eye disorders     
Light hurts eyes   0/25 (0.00%)  0 2/18 (11.11%)  2
Blurred/double Vision   0/25 (0.00%)  0 2/18 (11.11%)  2
Gastrointestinal disorders     
Nausea   1/25 (4.00%)  1 2/18 (11.11%)  2
Stomach Pains   2/25 (8.00%)  2 1/18 (5.56%)  1
Constipation   0/25 (0.00%)  0 1/18 (5.56%)  1
General disorders     
Fatigue   1/25 (4.00%)  3 0/18 (0.00%)  0
Dry Mouth   1/25 (4.00%)  1 1/18 (5.56%)  1
Headache   1/25 (4.00%)  1 2/18 (11.11%)  2
Drowsiness   0/25 (0.00%)  0 3/18 (16.67%)  3
Visit to ER: Aches   0/25 (0.00%)  0 1/18 (5.56%)  1
Metabolism and nutrition disorders     
Weight Loss   2/25 (8.00%)  2 2/18 (11.11%)  2
Decreased Appetite   1/25 (4.00%)  2 2/18 (11.11%)  2
Weight Gain   0/25 (0.00%)  0 1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders     
Leg Spasms   0/25 (0.00%)  0 1/18 (5.56%)  1
Nervous system disorders     
Trouble Sleeping   1/25 (4.00%)  1 1/18 (5.56%)  1
Nightmares   1/25 (4.00%)  1 1/18 (5.56%)  1
Insomnia   1/25 (4.00%)  2 0/18 (0.00%)  0
Dizziness   0/25 (0.00%)  0 2/18 (11.11%)  2
Numbness  [1]  0/25 (0.00%)  0 1/18 (5.56%)  1
Tingling  [2]  0/25 (0.00%)  0 1/18 (5.56%)  1
Trouble Keeping Balance   0/25 (0.00%)  0 1/18 (5.56%)  1
Room Spinning   0/25 (0.00%)  0 1/18 (5.56%)  1
Psychiatric disorders     
Agitated/Restlessness   1/25 (4.00%)  1 2/18 (11.11%)  2
Silliness/Feeling too happy   1/25 (4.00%)  2 0/18 (0.00%)  0
Emotional   1/25 (4.00%)  1 0/18 (0.00%)  0
Forgetfulness   0/25 (0.00%)  0 1/18 (5.56%)  1
Feeling tense   0/25 (0.00%)  0 2/18 (11.11%)  2
Renal and urinary disorders     
Delay in Urination   0/25 (0.00%)  0 1/18 (5.56%)  1
Reproductive system and breast disorders     
Menstrual Cramps   1/25 (4.00%)  1 1/18 (5.56%)  1
Skin and subcutaneous tissue disorders     
Itchiness   0/25 (0.00%)  0 1/18 (5.56%)  1
Hair Loss   0/25 (0.00%)  0 1/18 (5.56%)  1
Social circumstances     
Lit Paper on Fire   1/25 (4.00%)  1 0/18 (0.00%)  0
Visit to ER: Family Conflict   0/25 (0.00%)  0 1/18 (5.56%)  1
Indicates events were collected by systematic assessment
[1]
Hands and feet.
[2]
Hands and Feet
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Eric Hollander, MD
Organization: Montefiore Medical Center, Albert Einstein College of Medicine
Phone: 7189204287
Responsible Party: Eric Hollander, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00245635     History of Changes
Obsolete Identifiers: NCT00029471
Other Study ID Numbers: 09-10-302
7R01FD002613-04 ( U.S. FDA Grant/Contract )
First Submitted: October 26, 2005
First Posted: October 28, 2005
Results First Submitted: April 21, 2015
Results First Posted: June 29, 2015
Last Update Posted: April 27, 2018