Trial Outcomes & Findings for Fluoxetine in Pediatric Body Dysmorphic Disorder (NCT NCT00245635)

Last Updated: 2018-04-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

43 participants

Primary outcome timeframe

Baseline compared to the study endpoint (week 12) [two time points]

Results posted on

2018-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	Fluoxetine 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 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 Study STARTED	25	18
Overall Study COMPLETED	25	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fluoxetine in Pediatric Body Dysmorphic Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluoxetine n=25 Participants 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 n=18 Participants 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 n=43 Participants Total of all reporting groups
Age, Continuous	15.04 years n=39 Participants	14.88 years n=41 Participants	14.96 years n=35 Participants
Sex: Female, Male Female	18 Participants n=39 Participants	15 Participants n=41 Participants	33 Participants n=35 Participants
Sex: Female, Male Male	7 Participants n=39 Participants	3 Participants n=41 Participants	10 Participants n=35 Participants
Region of Enrollment United States	25 participants n=39 Participants	18 participants n=41 Participants	43 participants n=35 Participants
BDD-Y-BOCS	30.84 units on a scale STANDARD_DEVIATION 4.2 • n=39 Participants	35.16 units on a scale STANDARD_DEVIATION 5.10 • n=41 Participants	32.65 units on a scale STANDARD_DEVIATION 5.02 • n=35 Participants

PRIMARY outcome

Timeframe: Baseline compared to the study endpoint (week 12) [two time points]

Outcome measures

Outcome measures
Measure	Fluoxetine n=25 Participants 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 n=18 Participants 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.
Change in Total Score on the BDD-Y-BOCS Scale	-12.27 units on a scale Standard Deviation 11.78	-9.53 units on a scale Standard Deviation 12.07

Adverse Events

Fluoxetine

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fluoxetine n=25 participants at risk 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 n=18 participants at risk 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.
Psychiatric disorders Suicidal Behavior	4.0% 1/25 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	0.00% 0/18 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.

Other adverse events

Additional Information

Eric Hollander, MD

Montefiore Medical Center, Albert Einstein College of Medicine

Phone: 7189204287

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Fluoxetine n=25 participants at risk 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 n=18 participants at risk 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.
Gastrointestinal disorders Nausea	4.0% 1/25 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	11.1% 2/18 • Number of events 2 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Metabolism and nutrition disorders Weight Loss	8.0% 2/25 • Number of events 2 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	11.1% 2/18 • Number of events 2 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Nervous system disorders Trouble Sleeping	4.0% 1/25 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Nervous system disorders Nightmares	4.0% 1/25 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Gastrointestinal disorders Stomach Pains	8.0% 2/25 • Number of events 2 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Nervous system disorders Insomnia	4.0% 1/25 • Number of events 2 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	0.00% 0/18 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
General disorders Fatigue	4.0% 1/25 • Number of events 3 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	0.00% 0/18 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Metabolism and nutrition disorders Decreased Appetite	4.0% 1/25 • Number of events 2 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	11.1% 2/18 • Number of events 2 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Endocrine disorders Sweating	4.0% 1/25 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Psychiatric disorders Agitated/Restlessness	4.0% 1/25 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	11.1% 2/18 • Number of events 2 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
General disorders Dry Mouth	4.0% 1/25 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Psychiatric disorders Silliness/Feeling too happy	4.0% 1/25 • Number of events 2 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	0.00% 0/18 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
General disorders Headache	4.0% 1/25 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	11.1% 2/18 • Number of events 2 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Social circumstances Lit Paper on Fire	4.0% 1/25 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	0.00% 0/18 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Psychiatric disorders Emotional	4.0% 1/25 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	0.00% 0/18 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Reproductive system and breast disorders Menstrual Cramps	4.0% 1/25 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Psychiatric disorders Forgetfulness	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Eye disorders Light hurts eyes	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	11.1% 2/18 • Number of events 2 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Psychiatric disorders Feeling tense	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	11.1% 2/18 • Number of events 2 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Ear and labyrinth disorders Ears ringing	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	11.1% 2/18 • Number of events 2 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
General disorders Drowsiness	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	16.7% 3/18 • Number of events 3 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Nervous system disorders Dizziness	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	11.1% 2/18 • Number of events 2 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Eye disorders Blurred/double Vision	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	11.1% 2/18 • Number of events 2 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Social circumstances Visit to ER: Family Conflict	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
General disorders Visit to ER: Aches	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Skin and subcutaneous tissue disorders Itchiness	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Musculoskeletal and connective tissue disorders Leg Spasms	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Skin and subcutaneous tissue disorders Hair Loss	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Renal and urinary disorders Delay in Urination	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Nervous system disorders Numbness	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Nervous system disorders Tingling	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Gastrointestinal disorders Constipation	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Cardiac disorders Heart Pounding/Racing	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 2 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Nervous system disorders Trouble Keeping Balance	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Nervous system disorders Room Spinning	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Metabolism and nutrition disorders Weight Gain	0.00% 0/25 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.	5.6% 1/18 • Number of events 1 • Adverse Event data was collected throughout the course of the study. Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.