To investigate the safety and efficacy of long-term administration of aripiprazole by performing extended administration of the treatment administered in the preceding multicenter, double-blind, placebo-controlled, parallel group-comparison trial of aripiprazole in patients with bipolar disorder experiencing a manic or mixed episode (Study 031-06-003, hereafter "Study 003") in a double-blind manner to those patients who complete Study 003 and demonstrate drug efficacy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
99
oral, 24mg(4 tablets)/day
oral, 0mg(4tablets)/day
Unnamed facility
Hong Kong, China
Unnamed facility
Chubu Region, Japan
Unnamed facility
Chugoku Region, Japan
Unnamed facility
Hokkaido Region, Japan
Unnamed facility
Hokuriku Region, Japan
Unnamed facility
Kanto Region, Japan
Unnamed facility
Kinki Region, Japan
Unnamed facility
Kyushu Region, Japan
Unnamed facility
Shikoku Region, Japan
Unnamed facility
Tohoku Region, Japan
...and 2 more locations
Young Mania Rating Scale (YMRS)
Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated for each treatment group. 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) levated 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. YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome).
Time frame: Baseline (Day 1 of preceding study) , Day 154 or at discontinuation
Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)
Using LOCF datasets, descriptive statistics of actual values for change of CGI-BP severity of illness score (mania) from baseline (Day 1 of preceding study) to endpoint (Day 154) were calculated for each treatment group. CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components-mania, depression, and overall bipolar illness. CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill).
Time frame: Baseline (Day 1 of preceding study), Day 154 or at discontinuation
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