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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

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00606229
First received: January 19, 2008
Last updated: July 10, 2011
Last verified: July 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Bipolar I Disorder
 Drug: Aripiprazole
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Young Mania Rating Scale (YMRS) [ Time Frame: Pre, Week2, Weeek4, Week8, Week12, Week16, Week20, Week24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression - Bipolar Version (CGI-BP) [ Time Frame: Week2, Weeek4, Week8, Week12, Week16, Week20, Week24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Aripiprazole
oral, 24mg/day
Other Name: OPC-14597

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606229

Locations
Japan
Chugoku region, Japan
Hokuriku region, Japan
Kanto region, Japan
Kinki region, Japan
Shikoku region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Katsuhisa Saito Department of Clinical Research and Development, Division of New Product Evaluation and Development
  More Information

No publications provided

Responsible Party: Katsuhisa Saito, OPC-J
ClinicalTrials.gov Identifier: NCT00606229     History of Changes
Other Study ID Numbers: 031-07-001
Study First Received: January 19, 2008
Last Updated: July 10, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 17, 2013