Trial Outcomes & Findings for Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth (NCT NCT00617240)
NCT ID: NCT00617240
Last Updated: 2014-03-11
Results Overview
Change in BMI-Body Mass Index (BMI) is a measure of body fat based on height, weight,gender and chronological age. Change in BMI is calculated as 24 weeks BMI minus the baseline BMI.
COMPLETED
PHASE2
9 participants
0-24 weeks
2014-03-11
Participant Flow
The first subject was enrolled into the study in January 2007 and enrollment ended in June 2009. All participants came to the ASPIRE clinic for all study visits.
The study sought to recruit participants who had minimal or no prior exposure to second generation antipsychotics and no previous treatment with metformin.
Participant milestones
| Measure |
Metformin
metformin in doses from 250mg to 2000mg/day for 26 weeks
|
Placebo
Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Metformin
metformin in doses from 250mg to 2000mg/day for 26 weeks
|
Placebo
Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
Baseline Characteristics
Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth
Baseline characteristics by cohort
| Measure |
Metformin
n=5 Participants
metformin in doses from 250mg to 2000mg/day for 26 weeks
|
Placebo
n=4 Participants
Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
14.20 years
STANDARD_DEVIATION 1.643 • n=99 Participants
|
14.25 years
STANDARD_DEVIATION 2.754 • n=107 Participants
|
14.22 years
STANDARD_DEVIATION 2.048 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 0-24 weeksPopulation: All participants who took at least one dose of study treatment and had at least one post baseline assessment.
Change in BMI-Body Mass Index (BMI) is a measure of body fat based on height, weight,gender and chronological age. Change in BMI is calculated as 24 weeks BMI minus the baseline BMI.
Outcome measures
| Measure |
Metformin
n=5 Participants
metformin in doses from 250mg to 2000mg/day for 26 weeks
|
Placebo
n=4 Participants
Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
|
|---|---|---|
|
Change From Baseline to Week 24 in Body Mass Index (BMI)
|
1.620 kg/m^2
Standard Error 1.250
|
1.800 kg/m^2
Standard Error 0.5701
|
PRIMARY outcome
Timeframe: 24 weeksChange in weight is calculated as 24 weeks weight minus the baseline weight.
Outcome measures
| Measure |
Metformin
n=4 Participants
metformin in doses from 250mg to 2000mg/day for 26 weeks
|
Placebo
n=4 Participants
Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
|
|---|---|---|
|
Change From Baseline to Week 24 in Weight
|
6.138 kg
Standard Error 4.346
|
10.45 kg
Standard Error 5.882
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Only participants with complete data on fat mass at both baseline and 24 weeks were utilized.
Fat mass is a measure of excess body fat. Change in Fat Mass is calculated as 24 weeks fat mass minus the baseline fat mass.
Outcome measures
| Measure |
Metformin
n=3 Participants
metformin in doses from 250mg to 2000mg/day for 26 weeks
|
Placebo
n=4 Participants
Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
|
|---|---|---|
|
Change From Baseline to Week 24 in Fat Mass
|
4.770 kg
Standard Error 1.770
|
8.225 kg
Standard Error 1.580
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Only participants with complete data on insulin levels at both baseline and 24 weeks were utilized.
Insulin is a peptide hormone and regulates carbohydrate and fat metabolism in the body.Change in Insulin level is calculated as the 24 weeks insulin level minus the baseline insulin level.
Outcome measures
| Measure |
Metformin
n=2 Participants
metformin in doses from 250mg to 2000mg/day for 26 weeks
|
Placebo
n=2 Participants
Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
|
|---|---|---|
|
Change From Baseline to Week 24 in Insulin Level
|
1.550 microIU/ml
Standard Error 4.250
|
4.80 microIU/ml
Standard Error 2.60
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Only participants with complete data on cholesterol levels at both baseline and 24 weeks were utilized.
According to the lipid hypothesis, abnormal cholesterol levels are strongly associated with cardiovascular disease because these promote atherosclerosis.Cholesterol levels are measured in milligrams (mg) of cholesterol per deciliter(dL) of blood.Change in cholesterol levels is measured at 24 weeks minus the levels at baseline.
Outcome measures
| Measure |
Metformin
n=4 Participants
metformin in doses from 250mg to 2000mg/day for 26 weeks
|
Placebo
n=2 Participants
Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
|
|---|---|---|
|
Change From Baseline to Week 24 in Cholesterol Level
|
-4.250 mg/dl
Standard Error 17.07
|
-31.00 mg/dl
Standard Error 15.00
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Only participants with complete data on triglyceride levels at both baseline and 24 weeks were utilized.
In the human body, high levels of triglyceride fats in the bloodstream have been linked to atherosclerosis and, by extension, the risk of heart disease and stroke. A change in triglycerides is calculated from 24 weeks minus baseline levels.
Outcome measures
| Measure |
Metformin
n=3 Participants
metformin in doses from 250mg to 2000mg/day for 26 weeks
|
Placebo
n=2 Participants
Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
|
|---|---|---|
|
Change From Baseline to Week 24 in Triglycerides
|
-4.667 mg/dl
Standard Error 6.766
|
-0.5 mg/dl
Standard Error 0.5
|
SECONDARY outcome
Timeframe: 24 weeksMetabolic syndrome is a combination of the medical disorders that, when co-occurring, increase the risk of developing cardiovascular disease and diabetes.
Outcome measures
| Measure |
Metformin
n=5 Participants
metformin in doses from 250mg to 2000mg/day for 26 weeks
|
Placebo
n=4 Participants
Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
|
|---|---|---|
|
Incidence of Metabolic Syndrome
|
0 participants
|
0 participants
|
Adverse Events
Metformin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metformin
n=5 participants at risk
metformin in doses from 250mg to 2000mg/day for 26 weeks
|
Placebo
n=4 participants at risk
Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
|
|---|---|---|
|
Eye disorders
Glaucoma
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Abdominal discomfort/pain
|
20.0%
1/5 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Immune system disorders
Cold/Flu
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory/Ear Infection
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Motor Tics
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Psychiatric disorders
Low frustration tolerance
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Nervous system disorders
Motor stereotypies
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Increased sleep
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
Additional Information
Linmarie Sikich, MD
The University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place