Trial Outcomes & Findings for A Multicenter Investigative Study of the Safety and Efficacy of Long-term Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode (NCT NCT00606229)

Last Updated: 2014-03-13

Results Overview

Mean change from baseline (Day 1) to endpoint in the YMRS total score YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) elevated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior. Total score range is 0 to 60, and the higher value represents worsen.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

41 participants

Primary outcome timeframe

Day 1 and Day 168 or time of discontinuation

Results posted on

2014-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Aripiprazole Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
Overall Study STARTED	41
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Aripiprazole Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
Overall Study Adverse Event	11
Overall Study Lack of Efficacy	1
Overall Study Withdrawal by Subject	4
Overall Study does not meet inclusion criterion 1-3	4
Overall Study change of residence or other commitments	2

Baseline Characteristics

A Multicenter Investigative Study of the Safety and Efficacy of Long-term Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aripiprazole n=40 Participants Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
Age, Continuous	40.4 years STANDARD_DEVIATION 10.89 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment Japan	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 and Day 168 or time of discontinuation

Population: Results obtained from the LOCF dataset of 40 subjects of the Full Analysis Set (FAS) (excluding 1 subject whose post-dose data of efficacy endpoint were not available from the 41 treated subjects)

Outcome measures

Outcome measures
Measure	Aripiprazole n=40 Participants Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
Young Mania Rating Scale (YMRS)	-18.8 scores on a scale Standard Deviation 9.86

SECONDARY outcome

Timeframe: Day 1 and Daty 168 or time of discontinuation

Mean change from baseline (Day 1) to endpoint in Clinical Global Impression -Bipolar Version (CGI-BP) severity of illness score (mania) The severity of manic symptoms on a scale of 1 (normal, not ill) to 7 (very severely ill)

Outcome measures

Outcome measures
Measure	Aripiprazole n=40 Participants Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
Clinical Global Impression - Bipolar Version (CGI-BP) Sevirity of Illness Score (Mania)	-2.6 scores on a scale Standard Deviation 1.50

Adverse Events

Aripiprazole

Serious events: 4 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aripiprazole n=41 participants at risk Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
Musculoskeletal and connective tissue disorders Rhabdomyolysis	2.4% 1/41 • Number of events 1 • 24 weeks
Nervous system disorders Akathisia	2.4% 1/41 • Number of events 1 • 24 weeks
Psychiatric disorders Bipolar I Disorder	4.9% 2/41 • Number of events 3 • 24 weeks

Other adverse events

Other adverse events
Measure	Aripiprazole n=41 participants at risk Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
Gastrointestinal disorders Nausea	22.0% 9/41 • Number of events 9 • 24 weeks
Gastrointestinal disorders Salivary Hypersecretion	14.6% 6/41 • Number of events 6 • 24 weeks
Gastrointestinal disorders Vomiting	12.2% 5/41 • Number of events 10 • 24 weeks
Gastrointestinal disorders Diarrhoea	9.8% 4/41 • Number of events 5 • 24 weeks
Gastrointestinal disorders Constipation	7.3% 3/41 • Number of events 3 • 24 weeks
Gastrointestinal disorders Toothache	7.3% 3/41 • Number of events 3 • 24 weeks
Infections and infestations Nasopharyngitis	14.6% 6/41 • Number of events 8 • 24 weeks
Investigations Blood Creatine Phosphokinase Increased	17.1% 7/41 • Number of events 9 • 24 weeks
Investigations Weight Increased	17.1% 7/41 • Number of events 7 • 24 weeks
Investigations Blood Prolactin Decreased	7.3% 3/41 • Number of events 3 • 24 weeks
Musculoskeletal and connective tissue disorders Back Pain	7.3% 3/41 • Number of events 3 • 24 weeks
Nervous system disorders Akathisia	43.9% 18/41 • Number of events 20 • 24 weeks
Nervous system disorders Somnolence	34.1% 14/41 • Number of events 16 • 24 weeks
Nervous system disorders Tremor	22.0% 9/41 • Number of events 10 • 24 weeks
Nervous system disorders Bradykinesia	14.6% 6/41 • Number of events 7 • 24 weeks
Nervous system disorders Headache	9.8% 4/41 • Number of events 5 • 24 weeks
Psychiatric disorders Insomnia	14.6% 6/41 • Number of events 6 • 24 weeks
Skin and subcutaneous tissue disorders Blister	7.3% 3/41 • Number of events 3 • 24 weeks

Additional Information

Director of Clinical Research and Development

Otsuka Pharmaceutical CO., Ltd.

Phone: +81-3-6361-7366

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place