Trial Outcomes & Findings for Study of Aripiprazole (Abilify) in Children With Symptoms of Mania (NCT NCT00194077)

Results Overview

Time in weeks to discontinuation due to any reason, including mood event, adverse event, or other.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

60 participants

Primary outcome timeframe

up to 72 weeks

Results posted on

2015-01-07

Participant Flow

Recruitment University Hospitals, Case Medical Center

Open stabilization was initiated with aripiprazole at\~0.1mg/kg upon phase 1, open stabilization entry, n+96. Of these, 60 subjects met priori response to advance to phase 2.

Participant milestones

Participant milestones
Measure	Aripiprazole Random assignment with titrated dosing	Placebo Randomized assignment to placebo
Overall Study STARTED	30	30
Overall Study COMPLETED	6	0
Overall Study NOT COMPLETED	24	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Aripiprazole Random assignment with titrated dosing	Placebo Randomized assignment to placebo
Overall Study Lack of Efficacy	22	29
Overall Study Study nonadherence	1	0
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Study of Aripiprazole (Abilify) in Children With Symptoms of Mania

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aripiprazole n=30 Participants Abilify (Children with Symptoms of Mania Study)	Placebo n=30 Participants Placebo (Children with Symptoms of Mania Study)	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	23 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 72 weeks

Time in weeks to discontinuation due to any reason, including mood event, adverse event, or other.

Outcome measures

Outcome measures
Measure	Aripiprazole n=30 Participants Aripiprazole dosing dependent upon response	Placebo n=30 Participants Placebo dosing to mirror active treatment
Time in Weeks to Discontinuation	25.93 time in weeks to discontinuation Interval 15.08 to 36.78	3.00 time in weeks to discontinuation Interval 1.89 to 4.11

Adverse Events

Aripiprazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Robert Findling, MD,MBA Director, Child and Adolescent Psychiatry

Johns Hopkins University School of Medicine

Phone: 410-614-3225

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place