COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00606281
Recruitment Status : Completed
First Posted : February 1, 2008
Results First Posted : February 12, 2014
Last Update Posted : February 12, 2014
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Drug: Aripiprazole Drug: placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: 1 Drug: Aripiprazole
oral, 24mg/day
Other Name: OPC-14597

Placebo Comparator: 2 Drug: placebo
oral, 0mg(4tablets)/day
Other Name: OPC-14597

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Clinical Global Impression - Bipolar Version (CGI-BP), Severity of Illness Score (Mania) [ Time Frame: Day1, Day21 ]

    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  • 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
  • For patients who take lithium, valproate, or carbamazepine within 3 days prior to commencement of investigational product administration, those patients with serum concentrations of lithium greater than 0.6 mmol/L, serum concentrations of valproate greater than 50 µg/mL, or serum concentrations of carbamazepine greater than 4 µg/mL
  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00606281

Layout table for location information
HongKong, China
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
Taipei, Taiwan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Layout table for investigator information
Study Director: Katsuhisa Saito Department of Clinical Research and Development, Division of New Product Evaluation and Development
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Co., Ltd. Identifier: NCT00606281    
Other Study ID Numbers: 031-06-003
First Posted: February 1, 2008    Key Record Dates
Results First Posted: February 12, 2014
Last Update Posted: February 12, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists