Trial Outcomes & Findings for Effectiveness of Aripiprazole for Improving Side Effects of Clozapine in the Treatment of People With Schizophrenia (NCT NCT00345033)
NCT ID: NCT00345033
Last Updated: 2014-06-23
Results Overview
A comparison of aripiprazole group and placebo group in change in total cholesterol measured at Baseline and Week 8.
COMPLETED
PHASE4
38 participants
Measured at Baseline and Week 8
2014-06-23
Participant Flow
Subjects were recruited from the Freedom Trail Clinic at the Erich Lindemann Mental Health Center and were studied at the General Clinical Research Center (GCRC) at the Massachusetts General Hospital (MGH), Boston and the Freedom Trail Clinic.
After providing written informed consent, subjects underwent a diagnostic evaluation by a research psychiatrist using the Structured Clinical Interview for DSM-IV (SCID). All subjects were screened and enrolled based on eligibility criteria. Baseline study assessments were completed prior to intervention.
Participant milestones
| Measure |
Aripiprazole
Participants will take aripiprazole for 8 weeks.
|
Placebo
Participants will take placebo for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
18
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Aripiprazole for Improving Side Effects of Clozapine in the Treatment of People With Schizophrenia
Baseline characteristics by cohort
| Measure |
Aripiprazole
n=20 Participants
Participants will take aripiprazole for 8 weeks.
|
Placebo
n=18 Participants
Participants will take placebo for 8 weeks.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
44.25 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Baseline and Week 8Population: The number of participants for analysis (intent to treat) were those that completed the study (N = 30).
A comparison of aripiprazole group and placebo group in change in total cholesterol measured at Baseline and Week 8.
Outcome measures
| Measure |
Aripiprazole
n=16 Participants
Participants will take aripiprazole for 8 weeks.
|
Placebo
n=14 Participants
Participants will take placebo for 8 weeks.
|
|---|---|---|
|
Change in Total Cholesterol
|
-15.3 mg/dL
Standard Deviation 33.3
|
5.6 mg/dL
Standard Deviation 34.0
|
PRIMARY outcome
Timeframe: Measured at Baseline and Week 8Population: The number of participants for analysis (intent to treat) were those that completed the study (N=30).
A comparison between aripiprazole group and placebo group in change in weight measured at Baseline and Week 8.
Outcome measures
| Measure |
Aripiprazole
n=16 Participants
Participants will take aripiprazole for 8 weeks.
|
Placebo
n=14 Participants
Participants will take placebo for 8 weeks.
|
|---|---|---|
|
Change in Weight
|
-1.5 kg
Standard Deviation 2.3
|
0.3 kg
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Measured at Baseline and Week 8Population: The number of participants for analysis (intent to treat) were those that completed the study (N=30).
A comparison between aripiprazole group and placebo group of change in Body Mass Index (BMI) measured at Baseline and Week 8.
Outcome measures
| Measure |
Aripiprazole
n=16 Participants
Participants will take aripiprazole for 8 weeks.
|
Placebo
n=14 Participants
Participants will take placebo for 8 weeks.
|
|---|---|---|
|
Change in Body Mass Index (BMI)
|
-0.52 kg/m^2
Standard Deviation 0.79
|
0.03 kg/m^2
Standard Deviation 0.85
|
PRIMARY outcome
Timeframe: Measured at Baseline and Week 8Population: The number of participants for analysis (intent to treat) were those that completed the study (N=30).
A comparison between the aripiprazole group and placebo group in change in glucose metabolism measured at Baseline and Week 8.
Outcome measures
| Measure |
Aripiprazole
n=16 Participants
Participants will take aripiprazole for 8 weeks.
|
Placebo
n=14 Participants
Participants will take placebo for 8 weeks.
|
|---|---|---|
|
Change in Glucose Metabolism
|
0.003 min^-1
Standard Deviation 0.006
|
-0.005 min^-1
Standard Deviation 0.007
|
PRIMARY outcome
Timeframe: Measured at Baseline and Week 8Population: The number of participants for analysis (intent to treat) were those that completed the study (N=30)
Outcome measures
| Measure |
Aripiprazole
n=16 Participants
Participants will take aripiprazole for 8 weeks.
|
Placebo
n=14 Participants
Participants will take placebo for 8 weeks.
|
|---|---|---|
|
Change in Triglycerides
|
-5.9 mg/dL
Standard Deviation 75.1
|
-7.3 mg/dL
Standard Deviation 100.3
|
PRIMARY outcome
Timeframe: Measured at Baseline and Week 8Population: The number of participants for analysis (intent to treat) were those that completed the study (N=30)
A comparison between aripiprazole group and placebo group of change in insulin resistance measured at Baseline and Week 8.
Outcome measures
| Measure |
Aripiprazole
n=16 Participants
Participants will take aripiprazole for 8 weeks.
|
Placebo
n=14 Participants
Participants will take placebo for 8 weeks.
|
|---|---|---|
|
Change in Insulin Resistance
|
0.6 HOMA score
Standard Deviation 3.8
|
0.65 HOMA score
Standard Deviation 1.9
|
Adverse Events
Aripiprazole
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aripiprazole
n=16 participants at risk
Participants will take aripiprazole for 8 weeks.
|
Placebo
n=14 participants at risk
Participants will take placebo for 8 weeks.
|
|---|---|---|
|
General disorders
dizziness during IVGTT procedure
|
0.00%
0/16
|
7.1%
1/14 • Number of events 1
|
|
Eye disorders
eye irritation/swelling
|
6.2%
1/16 • Number of events 1
|
0.00%
0/14
|
|
Psychiatric disorders
psychiatric decompensation
|
6.2%
1/16 • Number of events 1
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
0.00%
0/16
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
stomach pain
|
0.00%
0/16
|
7.1%
1/14 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place