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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00606281
First received: January 19, 2008
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Bipolar I Disorder
Drug: Aripiprazole
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Young Mania Rating Scale (YMRS) [ Time Frame: Day1, Day21 ] [ Designated as safety issue: No ]

    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:
  • Clinical Global Impression - Bipolar Version (CGI-BP), Severity of Illness Score (Mania) [ Time Frame: Day1, Day21 ] [ Designated as safety issue: No ]

    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.



Enrollment: 258
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
Placebo Comparator: 2 Drug: placebo
oral, 0mg(4tablets)/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 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606281

Locations
China
HongKong, China
Japan
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
Taiwan
Taipei, Taiwan
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: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00606281     History of Changes
Other Study ID Numbers: 031-06-003
Study First Received: January 19, 2008
Results First Received: November 28, 2013
Last Updated: January 16, 2014
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 August 21, 2014