A Multicenter Investigative Study of the Safety and Efficacy of Long-term Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

Study Overview
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Brief Summary
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To assess the safety and efficacy of long-term administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner in patients with Bipolar I Disorder experiencing a manic or mixed episode

Official Title
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A Multicenter Investigative Study of the Safety and Efficacy of Long-term Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

Conditions
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Bipolar I Disorder

Intervention / Treatment
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* Drug: Aripiprazole


Participation Criteria
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Eligibility Criteria
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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 16 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) Patients at significant risk of developing a severe adverse event. Patients who have a medical condition that would interfere with assessments of safety or efficacy during the course of the trial, or who have a history of such a condition. Patients who have received any of the following treatments during the screening period Reserpine Levodopa, dopamine receptor stimulants Monoamine oxidase inhibitors Psychostimulants Thyroid hormones, antithyroid drugs Corticosteroids (other than topical preparations) Adrenaline All other investigational or unapproved agents ECT Light therapy Patients judged to have a diabetic blood glucose level (judgment based on use of a self-monitoring blood glucose meter permissible), or patients whose HbA1c is 6.5% or higher Patients with a history or a complication of diabetes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Aripiprazole<br>* oral, 24mg/day<br>* Other names: OPC-14597;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Young Mania Rating Scale (YMRS) | Mean change from baseline (Day 1) to endpoint in the YMRS total score 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. Total score range is 0 to 60, and the higher value represents worsen. | Day 1 and Day 168 or time of discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression - Bipolar Version (CGI-BP) Sevirity of Illness Score (Mania) | Mean change from baseline (Day 1) to endpoint in Clinical Global Impression -Bipolar Version (CGI-BP) severity of illness score (mania) The severity of manic symptoms on a scale of 1 (normal, not ill) to 7 (very severely ill) | Day 1 and Daty 168 or time of discontinuation |