Trial Outcomes & Findings for Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder (NCT NCT00665444)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

3 months

Results posted on

2017-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	Aripiprazole Aripiprazole Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic.
Overall Study STARTED	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Aripiprazole Aripiprazole Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic.
Overall Study Physician Decision	1
Overall Study Study Terminated by Study Sponsor	1

Baseline Characteristics

Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aripiprazole n=3 Participants Aripiprazole Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	56.7 years STANDARD_DEVIATION 4.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 3 month

Population: 0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Study was terminated early and data were not collected for this outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Study was terminated early and data were not collected for this outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Study was terminated early and data were not collected for this outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Study was terminated early and data were not collected for this outcome.

Outcome measures

Outcome data not reported

Adverse Events

Aripiprazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Holly Swartz, MD

University of Pittsburgh

Phone: 412-246-5588

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place