Trial Outcomes & Findings for Changes in Adiposity, Metabolic Measures From Atypicals to Aripiprazole (NCT NCT00205660)

NCT ID: NCT00205660

Last Updated: 2019-01-15

Results Overview

This study hypothesizes that switching to aripiprazole treatment will be associated with reductions in adipose tissue mass in comparison to olanzapine.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

51 participants

Primary outcome timeframe

12 Weeks

Results posted on

2019-01-15

Participant Flow

Participants were recruited from wide range of sites in the St. Louis community. Some advertising with flyers was used however the majority of the recruitment was done using community outreach, doctor-to-doctor or self-referrals, and referrals from board and care and community support programs. All recruitment materials were approved by the IRB.

Participants were enrolled in the study once they signed consent. After enrollment, participants were brought in for a screening visit consisting of a diagnostic interview, screening labs, a review of records and a discussion with their primary psychiatrist. If the patient met all inclusion criteria after screening, study visits were scheduled.

Participant milestones

Participant milestones
Measure	Stayers Participants in this arm were randomized to stay on their current antipsychotic.	Switchers Participants in this arm were randomized to switch to aripiprazole from their current antipsychotic.
Overall Study STARTED	14	37
Overall Study COMPLETED	12	35
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

1 participant was missing a waist measurement.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stay n=14 Participants Subjects in this group stayed on their current antipsychotic.	Switch n=37 Participants Subjects in this group switched to aripiprazole from their current antipsychotic.	Total n=51 Participants Total of all reporting groups
Age, Continuous	42.5 years STANDARD_DEVIATION 7.3 • n=14 Participants	37.4 years STANDARD_DEVIATION 11.1 • n=37 Participants	38.8 years STANDARD_DEVIATION 10.4 • n=51 Participants
Sex: Female, Male Female	4 Participants n=14 Participants	7 Participants n=37 Participants	11 Participants n=51 Participants
Sex: Female, Male Male	10 Participants n=14 Participants	30 Participants n=37 Participants	40 Participants n=51 Participants
Race/Ethnicity, Customized White	4 Participants n=14 Participants	10 Participants n=37 Participants	14 Participants n=51 Participants
Race/Ethnicity, Customized Non-White	10 Participants n=14 Participants	27 Participants n=37 Participants	37 Participants n=51 Participants
Weight	93.7 kilograms STANDARD_DEVIATION 18.7 • n=14 Participants	91.4 kilograms STANDARD_DEVIATION 20.1 • n=37 Participants	92.0 kilograms STANDARD_DEVIATION 19.5 • n=51 Participants
BMI	30.7 kilograms per squared meters STANDARD_DEVIATION 6.7 • n=14 Participants	30.6 kilograms per squared meters STANDARD_DEVIATION 6.2 • n=37 Participants	30.7 kilograms per squared meters STANDARD_DEVIATION 6.3 • n=51 Participants
Waist Circumference	101.8 centimeters STANDARD_DEVIATION 14.0 • n=13 Participants • 1 participant was missing a waist measurement.	103.7 centimeters STANDARD_DEVIATION 15.8 • n=37 Participants • 1 participant was missing a waist measurement.	103.2 centimeters STANDARD_DEVIATION 15.2 • n=50 Participants • 1 participant was missing a waist measurement.
DEXA Total Fat	29.7 kilograms STANDARD_DEVIATION 12.5 • n=14 Participants • 1 participant was missing a DEXA.	26.9 kilograms STANDARD_DEVIATION 10.9 • n=36 Participants • 1 participant was missing a DEXA.	27.7 kilograms STANDARD_DEVIATION 11.3 • n=50 Participants • 1 participant was missing a DEXA.
Whole Body Sensitivity	5.8 mg/kg/min STANDARD_DEVIATION 2.9 • n=14 Participants	4.6 mg/kg/min STANDARD_DEVIATION 2.7 • n=37 Participants	4.9 mg/kg/min STANDARD_DEVIATION 2.8 • n=51 Participants

PRIMARY outcome

Timeframe: 12 Weeks

Population: The analysis was "per protocol" and included subjects that completed both a baseline and endpoint assessment, which in this case, was a DEXA scan.

This study hypothesizes that switching to aripiprazole treatment will be associated with reductions in adipose tissue mass in comparison to olanzapine.

Outcome measures

Outcome measures
Measure	Stayers n=12 Participants The subjects in this arm stayed on their current antipsychotic following entry into the study.	Switchers n=34 Participants The subjects in this arm switched to aripiprazole from their current antipsychotic following entry into the study.	Total n=46 Participants This arm consists of pooled treatment groups (i.e., those who stayed on their current antipsychotic and those who switched to aripiprazole).
Change in Total Body Fat (kg).	0.15 change in kilograms Standard Deviation 1.96	-1.77 change in kilograms Standard Deviation 2.66	-1.27 change in kilograms Standard Deviation 2.62

PRIMARY outcome

Timeframe: 12 Weeks

Population: The analysis was "per protocol" and included subjects that completed both a baseline and endpoint assessment, which in this case, was a hyperinsulinemic euglycemic clamp.

This study hypothesized that switching to aripiprazole treatment will be associated with statistically significant improvements in whole body sensitivity (mg/kg/min) in comparison to chronic pretreatment with olanzapine.

Outcome measures

Outcome measures
Measure	Stayers n=12 Participants The subjects in this arm stayed on their current antipsychotic following entry into the study.	Switchers n=34 Participants The subjects in this arm switched to aripiprazole from their current antipsychotic following entry into the study.	Total n=46 Participants This arm consists of pooled treatment groups (i.e., those who stayed on their current antipsychotic and those who switched to aripiprazole).
Change in Whole Body Sensitivity (mg/kg/Min)	-0.67 change in mg/kg/min Standard Deviation 1.12	1.19 change in mg/kg/min Standard Deviation 2.09	0.70 change in mg/kg/min Standard Deviation 2.05

Adverse Events

Stay

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Switch

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Stay n=12 participants at risk Includes subjects who stayed on their current antipsychotic throughout the study	Switch n=35 participants at risk Includes subjects who switched to aripiprazole
General disorders Hunger	8.3% 1/12 • Adverse events were collected throughout the entire course of the 12-week study.	25.7% 9/35 • Adverse events were collected throughout the entire course of the 12-week study.
General disorders Drowsiness/Somnolence	8.3% 1/12 • Adverse events were collected throughout the entire course of the 12-week study.	20.0% 7/35 • Adverse events were collected throughout the entire course of the 12-week study.
General disorders Tiredness/Fatigue	0.00% 0/12 • Adverse events were collected throughout the entire course of the 12-week study.	20.0% 7/35 • Adverse events were collected throughout the entire course of the 12-week study.

Additional Information

Michael Yingling

Washington University

Phone: 5735791412

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place