Trial Outcomes & Findings for Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome (NCT NCT00288366)

Last Updated: 2019-08-06

Results Overview

change in HDL ratio after medication switch

Recruitment status

COMPLETED

Study phase

Target enrollment

49 participants

Primary outcome timeframe

24 weeks from Baseline

Results posted on

2019-08-06

Participant milestones
Measure	Aripiprazole aripiprazole (Abilify) ziprasidone vs. aripiprazole: ziprasidone vs. aripiprazole dosed according to package insert aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert	Ziprasidone ziprasidone (Geodon) aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert
Overall Study STARTED	23	26
Overall Study COMPLETED	23	26
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome

Baseline characteristics by cohort
Measure	Aripiprazole n=23 Participants aripiprazole (Abilify) ziprasidone vs. aripiprazole: ziprasidone vs. aripiprazole dosed according to package insert aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert	Ziprasidone n=26 Participants ziprasidone (Geodon) aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert	Total n=49 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	23 Participants n=5 Participants	26 Participants n=7 Participants	49 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 8.5 • n=5 Participants	45.5 years STANDARD_DEVIATION 9.4 • n=7 Participants	44.9 years STANDARD_DEVIATION 8.95 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	26 participants n=7 Participants	49 participants n=5 Participants

Timeframe: 24 weeks from Baseline

change in HDL ratio after medication switch

Outcome measures
Measure	Aripiprazole n=23 Participants aripiprazole (Abilify) ziprasidone vs. aripiprazole: ziprasidone vs. aripiprazole dosed according to package insert aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert	Ziprasidone n=26 Participants ziprasidone (Geodon) aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert
HDL Ratio Baseline	39.7 unit of Measure ''g/dL'' Standard Error 1.6	38.4 unit of Measure ''g/dL'' Standard Error 1.5
HDL Ratio 24 weeks	43.5 unit of Measure ''g/dL'' Standard Error 2.1	42.3 unit of Measure ''g/dL'' Standard Error 1.8

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Aripiprazole n=23 participants at risk aripiprazole (Abilify) ziprasidone vs. aripiprazole: ziprasidone vs. aripiprazole dosed according to package insert aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert	Ziprasidone n=26 participants at risk ziprasidone (Geodon) aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert
Nervous system disorders Worsening of psychiatric symptoms	4.3% 1/23 • Number of events 1	0.00% 0/26

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