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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

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ClinicalTrials.gov Identifier: NCT00606229
Recruitment Status : Completed
First Posted : February 1, 2008
Results First Posted : March 13, 2014
Last Update Posted : March 13, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Bipolar I Disorder Drug: Aripiprazole Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2008
Primary Completion Date : November 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

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

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Young Mania Rating Scale (YMRS) [ Time Frame: Day 1 and Day 168 or time of discontinuation ]

    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.



Secondary Outcome Measures :
  1. Clinical Global Impression - Bipolar Version (CGI-BP) Sevirity of Illness Score (Mania) [ Time Frame: Day 1 and Daty 168 or time of discontinuation ]

    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)



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00606229     History of Changes
Other Study ID Numbers: 031-07-001
First Posted: February 1, 2008    Key Record Dates
Results First Posted: March 13, 2014
Last Update Posted: March 13, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs