Trial Outcomes & Findings for Improving Metabolic Parameters of Antipsychotic Child Treatment With Ziprasidone, Aripiprazole, and Clozapine (NCT NCT00617058)
NCT ID: NCT00617058
Last Updated: 2012-12-31
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
24 weeks
Results posted on
2012-12-31
Participant Flow
Potential subjects will be identified through referrals that the research program receives for other clinical trials involving the same age population with similar diagnoses. We also plan to access PHI to identify potential subjects and use MIM and the ISD helpdesk to complete hospital review of individuals ages 10-17 taking an antipsychotic.
Randomization will be completed using computer generated randomization schedules. In order to preserve adequate sample sizes in the cells, important variables such as pubertal status, concomitant valproic acid, concomitant stimulants, gender, race (Asian/Caucasian vs. Other), and ethnicity (Hispanic/Non-Hispanic) will be examined as covariates.
Participant milestones
| Measure |
Co-Treatment With Metformin
metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID
|
Healthy Lifestyle Instruction Group
Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.
|
Elective Monitoring Control Group
For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Metabolic Parameters of Antipsychotic Child Treatment With Ziprasidone, Aripiprazole, and Clozapine
Baseline characteristics by cohort
| Measure |
Co-Treatment With Metformin
n=1 Participants
metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID
|
Healthy Lifestyle Instruction Group
Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.
|
Elective Monitoring Control Group
For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Categorical
<=18 years
|
1 participants
n=5 Participants
|
—
|
—
|
1 participants
n=4 Participants
|
|
Age Categorical
Between 18 and 65 years
|
0 participants
n=5 Participants
|
—
|
—
|
0 participants
n=4 Participants
|
|
Age Categorical
>=65 years
|
0 participants
n=5 Participants
|
—
|
—
|
0 participants
n=4 Participants
|
|
Age Continuous
|
17 years
n=5 Participants
|
—
|
—
|
17 years
n=4 Participants
|
|
Gender
Female
|
0 participants
n=5 Participants
|
—
|
—
|
0 participants
n=4 Participants
|
|
Gender
Male
|
1 participants
n=5 Participants
|
—
|
—
|
1 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
—
|
1 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: This research study only enrolled a single study participant before the entire research study was terminated due to the start of a larger, multi-site trial evaluating similar outcome measures.
Outcome measures
| Measure |
Co-Treatment With Metformin
n=1 Participants
metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID
|
Healthy Lifestyle Instruction Group
Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.
|
Elective Monitoring Control Group
For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
|
|---|---|---|---|
|
Percent Change in BMI
|
-2.65 percent change
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Co-Treatment With Metformin
n=1 Participants
metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID
|
Healthy Lifestyle Instruction Group
Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.
|
Elective Monitoring Control Group
For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
|
|---|---|---|---|
|
Absolute Change in Weight
|
-10.6 lbs.
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Co-Treatment With Metformin
n=1 Participants
metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID
|
Healthy Lifestyle Instruction Group
Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.
|
Elective Monitoring Control Group
For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
|
|---|---|---|---|
|
Percent Change in Fat Mass
|
3.80 percent change
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Co-Treatment With Metformin
n=1 Participants
metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID
|
Healthy Lifestyle Instruction Group
Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.
|
Elective Monitoring Control Group
For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
|
|---|---|---|---|
|
Percent Change in Weight
|
-4.00 percent change
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Co-Treatment With Metformin
n=1 Participants
metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID
|
Healthy Lifestyle Instruction Group
Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.
|
Elective Monitoring Control Group
For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
|
|---|---|---|---|
|
Percent Change in Insulin Levels
|
-23.08 percent change
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Co-Treatment With Metformin
n=1 Participants
metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID
|
Healthy Lifestyle Instruction Group
Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.
|
Elective Monitoring Control Group
For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
|
|---|---|---|---|
|
Percent Change in Total Cholesterol
|
2.84 percent change
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Co-Treatment With Metformin
n=1 Participants
metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID
|
Healthy Lifestyle Instruction Group
Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.
|
Elective Monitoring Control Group
For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
|
|---|---|---|---|
|
Percent Change in Triglycerides
|
46.60 percent change
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Co-Treatment With Metformin
n=1 Participants
metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID
|
Healthy Lifestyle Instruction Group
Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.
|
Elective Monitoring Control Group
For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
|
|---|---|---|---|
|
Incidence of Metabolic Syndrome
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Co-Treatment With Metformin
n=1 Participants
metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID
|
Healthy Lifestyle Instruction Group
Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.
|
Elective Monitoring Control Group
For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
|
|---|---|---|---|
|
Percent Change in Glucose Levels
|
-3.41 percent change
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Co-Treatment With Metformin
n=1 Participants
metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID
|
Healthy Lifestyle Instruction Group
Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.
|
Elective Monitoring Control Group
For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
|
|---|---|---|---|
|
Percent Change in HDL
|
7.04 percent change
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Co-Treatment With Metformin
n=1 Participants
metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID
|
Healthy Lifestyle Instruction Group
Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.
|
Elective Monitoring Control Group
For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
|
|---|---|---|---|
|
Percent Change in LDL
|
-5.74 percent change
|
—
|
—
|
Adverse Events
Co-Treatment With Metformin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Lifestyle Instruction Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Elective Monitoring Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Linmarie Sikich, M.D.
The University of North Carolina at Chapel Hill
Phone: (919) 972-7499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place