Trial Outcomes & Findings for Side Effect Study of Antipsychotic Medicines to Treat Childhood Bipolar Disorder (NCT NCT00746252)
NCT ID: NCT00746252
Last Updated: 2020-01-06
Results Overview
Weight gain from baseline to last observation up to 12 weeks. Last observation carried to 12 weeks.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
These measurements are done biweekly from baseline up until 12 weeks
Results posted on
2020-01-06
Participant Flow
Two participants enrolled and completed baseline assessments but were withdrawn from the study at baseline due to the following reasons: 1. Abnormal glucose tolerance test requiring further assessment with endocrinology. 2. Unable to complete lab work due to increased distress.
Participant milestones
| Measure |
Risperidone
risperidone
risperidone: Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing.
|
Aripiprazole
aripiprazole
aripiprazole: children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Risperidone
risperidone
risperidone: Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing.
|
Aripiprazole
aripiprazole
aripiprazole: children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months.
|
|---|---|---|
|
Overall Study
weight gain >7.5 %
|
1
|
2
|
Baseline Characteristics
Side Effect Study of Antipsychotic Medicines to Treat Childhood Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Risperidone
n=1 Participants
risperidone
risperidone: Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing.
|
Aripiprazole
n=2 Participants
aripiprazole
aripiprazole: children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.75 years
STANDARD_DEVIATION 0 • n=93 Participants
|
12.5 years
STANDARD_DEVIATION 0 • n=4 Participants
|
10.9 years
STANDARD_DEVIATION 2.78 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=93 Participants
|
2 participants
n=4 Participants
|
3 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: These measurements are done biweekly from baseline up until 12 weeksWeight gain from baseline to last observation up to 12 weeks. Last observation carried to 12 weeks.
Outcome measures
| Measure |
Risperidone
n=1 Participants
risperidone
risperidone: Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing.
|
Aripiprazole
n=2 Participants
aripiprazole
aripiprazole: children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months.
|
|---|---|---|
|
Weight Gain
|
8.5 pounds
Standard Deviation NA
Unable to calculate SD for 1 participant.
|
6.65 pounds
Standard Deviation 1.48
|
Adverse Events
Risperidone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Aripiprazole
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Risperidone
n=1 participants at risk
risperidone
risperidone: Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing.
|
Aripiprazole
n=2 participants at risk
aripiprazole
aripiprazole: children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months.
|
|---|---|---|
|
Metabolism and nutrition disorders
Weight gain
|
100.0%
1/1 • Number of events 1
|
100.0%
2/2 • Number of events 2
|
Additional Information
Gloria M. Reeves, M.D.
University of Marylland, Baltimore
Phone: 410-706-3522
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place