A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
The primary objective of this trial is to evaluate the clinical efficacy and safety of aripiprazole in comparison to placebo in patients with Bipolar I Disorder experiencing a manic or mixed episode.
|Study Design:||Allocation: 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, Randomized, Double-Blind, Placebo-Controlled, Parallel Group-Comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode|
- Young Mania Rating Scale (YMRS) [ Time Frame: Day1, Day21 ] [ Designated as safety issue: No ]
Using LOCF datasets, change in YMRS total score from baseline (Day 1) to endpoint (Day 21) was evaluated through analysis of covariance(ANCOVA).
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.
YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome).
- Clinical Global Impression - Bipolar Version (CGI-BP), Severity of Illness Score (Mania) [ Time Frame: Day1, Day21 ] [ Designated as safety issue: No ]
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).
Using LOCF datasets, change in CGI-BP severity of illness score (mania) from baseline (Day 1) to endpoint (Day 21) was evaluated through ANCOVA.
|Study Start Date:||January 2008|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
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|