A Multicenter, Placebo-controlled, Double-blind Investigative Extension Trial of the Safety and Efficacy of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Placebo-controlled, Double-blind Investigative Extension Trial of the Safety and Efficacy of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode|
- Young Mania Rating Scale (YMRS) [ Time Frame: Baseline (Day 1 of preceding study) , Day 154 or at discontinuation ] [ Designated as safety issue: No ]
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).
- Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania) [ Time Frame: Baseline (Day 1 of preceding study), Day 154 or at discontinuation ] [ Designated as safety issue: No ]
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).
|Study Start Date:||January 2008|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
oral, 24mg(4 tablets)/day
Other Name: OPC-14597
|Placebo Comparator: 2||
Other Name: OPC-14597
|Chubu region, Japan|
|Chugoku region, Japan|
|Hokkaido region, Japan|
|Hokuriku region, Japan|
|Kanto region, Japan|
|Kinki region, Japan|
|Kyushu region, Japan|
|Shikoku region, Japan|
|Tohoku region, Japan|
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Study Director:||Katsuhisa Saito||Department of Clinical Research and Development, Division of New Product Evaluation and Development|