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
Overview
- Phase
- Phase 3
- Intervention
- Aripiprazole
- Conditions
- Bipolar I Disorder
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Enrollment
- 258
- Primary Endpoint
- Young Mania Rating Scale (YMRS)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Trial subjects will be men and women of age 18 or above and below the age of 65 who will not be turning 65 during the trial.
- •Patients have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial.
- •Patients who meet DSM-IV-TR criteria for manic or mixed episodes and have been diagnosed as having "296.4x Bipolar I Disorder in which the most recent episode was manic" or "296.6x Bipolar I Disorder in which the most recent episode was mixed"
- •Patients with a YMRS total score of 20 or more
Exclusion Criteria
- •Patients presenting with a clinical picture and/or history that is consistent with a DSM-IV-TR diagnosis of:
- •Delirium, dementia, amnestic disorder, or other cognitive disorders
- •Schizophrenia or other psychotic disorder
- •Personality disorder
- •Patients experiencing their first manic or mixed episode
- •Patients whose current manic episode has lasted for more than 4 weeks
- •Patients with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance
- •Patients who have met DSM-IV-TR criteria for a substance-related disorder within 3 months (90 days) prior to informed consent (excluding caffeine- and nicotine-related disorders, but including abuse of benzodiazepines)
- •Patients who have received ECT treatment within 8 weeks prior to informed consent
- •Patients who are expected to require administration of ultrashort-acting or short-acting benzodiazepine receptor agonist hypnotics and antianxiety drugs (See (1) of 4.2.2) at doses exceeding the equivalent of 15 mg/day of diazepam (Only for those patients using such drugs)
Arms & Interventions
1
Intervention: Aripiprazole
2
Intervention: placebo
Outcomes
Primary Outcomes
Young Mania Rating Scale (YMRS)
Time Frame: Day1, Day21
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).
Secondary Outcomes
- Clinical Global Impression - Bipolar Version (CGI-BP), Severity of Illness Score (Mania)(Day1, Day21)