Trial Outcomes & Findings for Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder (NCT NCT00592852)
NCT ID: NCT00592852
Last Updated: 2025-01-28
Results Overview
This sale measures impairment on 5 items relating to Obsessions from 0 (none) to 4 (extreme) and 5 item relating to Compulsions from 0 (none) to 4 (extreme). These scores are totaled for a range of 0 (least impaired) to 40 (most impaired).
TERMINATED
PHASE4
13 participants
weekly
2025-01-28
Participant Flow
Participant milestones
| Measure |
Fluoxetine
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Fluoxetine
|
|---|---|
|
Overall Study
Non-compliance
|
1
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Found ineligible
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Fluoxetine
n=13 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
12.46 years
STANDARD_DEVIATION 3.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: weeklyPopulation: 2 participants were not included in final analysis - 1 terminated at 1 week due to non-compliance with taking study medication. 1 found ineligible prior to beginning treatment.
This sale measures impairment on 5 items relating to Obsessions from 0 (none) to 4 (extreme) and 5 item relating to Compulsions from 0 (none) to 4 (extreme). These scores are totaled for a range of 0 (least impaired) to 40 (most impaired).
Outcome measures
| Measure |
Fluoxetine
n=11 Participants
|
|---|---|
|
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
|
14.18 Units on a scale
Standard Deviation 9.98
|
SECONDARY outcome
Timeframe: weeklyPopulation: 2 participants were not included in final analysis - 1 terminated at 1 week due to non-compliance with taking study medication. 1 found ineligible prior to beginning treatment.
This scale measures mania symptoms in children and adolescents using 11 items rated from 0 (least severe) to 4 (most severe), although 4 items are rated from 0-8. The minimum (least severe) possible score is 0, and the maximum (most severe) possible score is 60.
Outcome measures
| Measure |
Fluoxetine
n=11 Participants
|
|---|---|
|
Young Mania Rating Scale (YMRS)
|
13 Units on a scale
Standard Deviation 12.54
|
Adverse Events
Fluoxetine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluoxetine
n=11 participants at risk
|
|---|---|
|
Skin and subcutaneous tissue disorders
bilateral medial thigh skin lesion
|
9.1%
1/11 • Number of events 1
|
|
Eye disorders
blurred vision (distance)
|
9.1%
1/11 • Number of events 1
|
|
General disorders
chest uneasiness
|
9.1%
1/11 • Number of events 1
|
|
General disorders
decreased appetite
|
9.1%
1/11 • Number of events 1
|
|
Ear and labyrinth disorders
dizziness
|
18.2%
2/11 • Number of events 3
|
|
General disorders
drooling
|
9.1%
1/11 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
eczema rash
|
9.1%
1/11 • Number of events 1
|
|
Renal and urinary disorders
frequent urination
|
9.1%
1/11 • Number of events 1
|
|
General disorders
headache
|
18.2%
2/11 • Number of events 4
|
|
Injury, poisoning and procedural complications
hurt cheek playing soccer
|
9.1%
1/11 • Number of events 1
|
|
General disorders
increased appetite
|
27.3%
3/11 • Number of events 8
|
|
General disorders
irritable
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
nausea
|
9.1%
1/11 • Number of events 1
|
|
General disorders
nose bleed
|
9.1%
1/11 • Number of events 1
|
|
General disorders
runny nose
|
9.1%
1/11 • Number of events 1
|
|
General disorders
sleep disturbance
|
9.1%
1/11 • Number of events 1
|
|
General disorders
tiredness
|
27.3%
3/11 • Number of events 3
|
|
Gastrointestinal disorders
vomiting
|
9.1%
1/11 • Number of events 1
|
|
Psychiatric disorders
worsening of manic symptoms
|
27.3%
3/11 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place