Trial Outcomes & Findings for A Placebo-Controlled, Cross-Over Trial of Aripiprazole (NCT NCT00351936)
NCT ID: NCT00351936
Last Updated: 2013-02-04
Results Overview
Evaluating change in weight (lbs) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.
COMPLETED
PHASE4
16 participants
baseline, week 4
2013-02-04
Participant Flow
Potential subjects will be identified by their clinicians at the Freedom Trail Clinic. Targeted enrollment will include 20 stable outpatients with schizophrenia or schizoaffective disorder treated with olanzapine for at least one year. Patients will be excluded for significant medical illness, and substance abuse.
Sixteen subjects consented to participate. One subject was found ineligible for the study due to recent changes in medications and did not reach baseline/group assignment. Available data from the remaining 15 subjects are included in all analyses.
Participant milestones
| Measure |
Cross-over Aripiprazole and Placebo
This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.
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|---|---|
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Overall Study
STARTED
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15
|
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Overall Study
COMPLETED
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15
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Placebo-Controlled, Cross-Over Trial of Aripiprazole
Baseline characteristics by cohort
| Measure |
Cross-over Aripiprazole and Placebo
n=15 Participants
This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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15 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=99 Participants
|
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Age Continuous
|
49.87 years
STANDARD_DEVIATION 7.96 • n=99 Participants
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Sex: Female, Male
Female
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5 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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10 Participants
n=99 Participants
|
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Region of Enrollment
United States
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15 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: baseline, week 4Evaluating change in weight (lbs) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.
Outcome measures
| Measure |
Aripiprazole
n=15 Participants
Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
|
Placebo
n=15 Participants
Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
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|---|---|---|
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Change From Baseline in Weight (Lbs)
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-2.9 lbs
Standard Deviation 4.7
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2.1 lbs
Standard Deviation 3.3
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PRIMARY outcome
Timeframe: baseline, week 4Evaluating change in Body Mass Index (BMI) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.
Outcome measures
| Measure |
Aripiprazole
n=15 Participants
Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
|
Placebo
n=15 Participants
Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
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|---|---|---|
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Change From Baseline in Body Mass Index (BMI)
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-0.4 kg/m^2
Standard Deviation 0.7
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0.3 kg/m^2
Standard Deviation 0.5
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PRIMARY outcome
Timeframe: baseline, week 4Evaluating change in waist-hip ratio (WHR) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.
Outcome measures
| Measure |
Aripiprazole
n=15 Participants
Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
|
Placebo
n=15 Participants
Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
|
|---|---|---|
|
Change From Baseline in Waist-hip Ratio (WHR)
|
0.0 cm
Standard Deviation 0.0
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0.0 cm
Standard Deviation 0.0
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PRIMARY outcome
Timeframe: baseline, week 4Evaluating change in fasting total cholesterol between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.
Outcome measures
| Measure |
Aripiprazole
n=15 Participants
Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
|
Placebo
n=15 Participants
Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
|
|---|---|---|
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Change From Baseline in Fasting Total Cholesterol
|
-3 mg/dL
Standard Deviation 24
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9 mg/dL
Standard Deviation 22
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PRIMARY outcome
Timeframe: baseline, week 4Evaluating change in low-density lipoprotein (LDL) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.
Outcome measures
| Measure |
Aripiprazole
n=15 Participants
Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
|
Placebo
n=15 Participants
Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
|
|---|---|---|
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Change From Baseline in Low-density Lipoprotein (LDL)
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-0.2 mg/dL
Standard Deviation 22.2
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3.1 mg/dL
Standard Deviation 15
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PRIMARY outcome
Timeframe: baseline, week 4Evaluating change in high-density lipoprotein cholesterol (HDL-C) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.
Outcome measures
| Measure |
Aripiprazole
n=15 Participants
Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
|
Placebo
n=15 Participants
Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
|
|---|---|---|
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Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
|
0.4 mg/dL
Standard Deviation 7.2
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0.6 mg/dL
Standard Deviation 3.0
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PRIMARY outcome
Timeframe: baseline, week 4Evaluating change in triglyceride levels between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.
Outcome measures
| Measure |
Aripiprazole
n=15 Participants
Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
|
Placebo
n=15 Participants
Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
|
|---|---|---|
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Change From Baseline in Triglycerides
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-51.7 mg/dL
Standard Deviation 78.2
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47.6 mg/dL
Standard Deviation 52.7
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Adverse Events
Cross-over Aripiprazole and Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cross-over Aripiprazole and Placebo
n=15 participants at risk
This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.
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|---|---|
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Gastrointestinal disorders
diarrhea
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6.7%
1/15 • Number of events 1
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Additional Information
Dr. David Henderson
Massachusetts General Hospital Schizophrenia Research Program
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place