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
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|ClinicalTrials.gov Identifier: NCT00606177|
Recruitment Status : Completed
First Posted : February 1, 2008
Results First Posted : February 12, 2014
Last Update Posted : February 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Bipolar I Disorder||Drug: Aripiprazole Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||January 2008|
|Primary Completion Date :||November 2010|
|Study Completion Date :||November 2010|
oral, 24mg(4 tablets)/day
Other Name: OPC-14597
|Placebo Comparator: 2||
Other Name: OPC-14597
- Young Mania Rating Scale (YMRS) [ Time Frame: Baseline (Day 1 of preceding study) , Day 154 or at discontinuation ]
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 ]
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606177
|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|