Trial Outcomes & Findings for A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome (NCT NCT00508157)

NCT ID: NCT00508157

Last Updated: 2013-12-13

Results Overview

Non-HDL cholesterol was calculated as fasting Total Cholesterol minus fasting HDL Cholesterol.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

125 participants

Primary outcome timeframe

Baseline, Week 16

Results posted on

2013-12-13

Participant Flow

125 participants were enrolled in this study; 73 were considered baseline failures and were not randomized.

Participant milestones

Participant milestones
Measure	Control Group Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator's judgment. Participants were treated for 16 weeks.	Aripiprazole Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
Overall Study STARTED	26	26
Overall Study Randomized Sample	26	26
Overall Study Safety Sample	26	25
Overall Study COMPLETED	24	23
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator's judgment. Participants were treated for 16 weeks.	Aripiprazole Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
Overall Study Adverse Event	0	1
Overall Study Subject Withdrew Consent	1	0
Overall Study Lost to Follow-up	1	0
Overall Study Subject no longer met study criteria	0	1
Overall Study Other known cause	0	1

Baseline Characteristics

A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=26 Participants Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator's judgment. Participants were treated for 16 weeks.	Aripiprazole n=26 Participants Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.	Total n=52 Participants Total of all reporting groups
Waist Circumference	107.1 cm n=5 Participants	107.1 cm n=7 Participants	107.1 cm n=5 Participants
Weight	89.1 kg STANDARD_DEVIATION 15.06 • n=5 Participants	91.6 kg STANDARD_DEVIATION 18.83 • n=7 Participants	90.3 kg STANDARD_DEVIATION 16.93 • n=5 Participants
Age, Continuous	40.7 years STANDARD_DEVIATION 10.47 • n=5 Participants	43.9 years STANDARD_DEVIATION 11.16 • n=7 Participants	42.3 years STANDARD_DEVIATION 10.84 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized White	23 participants n=5 Participants	26 participants n=7 Participants	49 participants n=5 Participants
Race/Ethnicity, Customized Black/African American	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Body Mass Index (BMI) category < 30 kg/m2	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Body Mass Index (BMI) category >=30 kg/m2	19 Participants n=5 Participants	13 Participants n=7 Participants	32 Participants n=5 Participants
Waist Circumference Category ≤ 102 cm for Men/ ≤ 88 cm for Women	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Waist Circumference Category > 102 cm for Men/ > 88 cm for Women	25 participants n=5 Participants	24 participants n=7 Participants	49 participants n=5 Participants
Body Mass Index (BMI)	31.45 kg/m2 n=5 Participants	31.31 kg/m2 n=7 Participants	31.38 kg/m2 n=5 Participants
Fasting Non-High Density Lipoprotein (HDL) Cholesterol	173.1 mg/dL n=5 Participants	169.0 mg/dL n=7 Participants	171.0 mg/dL n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: Last Observation Carried Forward (LOCF) data set, Non-HDL measurements obtained after start of a treatment with a lipid-lowering agent were excluded; last measurement prior was used for LOCF analyses. Baseline data was carried forward for LOCF analysis for subjects for whom no on-treatment measurements for fasting non-HDL cholesterol was available.

Non-HDL cholesterol was calculated as fasting Total Cholesterol minus fasting HDL Cholesterol.

Outcome measures

Outcome measures
Measure	Control Group n=26 Participants Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator's judgment. Participants were treated for 16 weeks.	Aripiprazole n=25 Participants Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16	10.06 percent change Standard Error 4.35	-2.3 percent change Standard Error 3.85

SECONDARY outcome

Timeframe: Week 16

Population: LOCF, Safety Sample For handling missing values, the metabolic syndrome is assumed to be ongoing unless there is enough data to support the resolution of the metabolic syndrome.

Metabolic syndrome is defined as the presence of at least 3 out of the following Adult Treatment Panel III-A (ATP III-A) criteria (all of which are to be assessed at the same visit): waist \>102 cm in males, \>88 cm in females; blood pressure (BP) systolic BP ≥130 or diastolic BP ≥85 mm Hg; fasting HDL \<40 mg/dL in males, \<50 mg/dL in females; fasting triglycerides ≥150 mg/dL; fasting glucose ≥100 mg/dL, and/or the start of a treatment for any of the parameters of metabolic syndrome during the course of the study.