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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

Primary Purpose

Bipolar I Disorder

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar I Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
January 19, 2008
Last Updated
February 11, 2014
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00606229
Brief 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
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 Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar I Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
OPC-14597
Intervention Description
oral, 24mg/day
Primary Outcome Measure Information:
Title
Young Mania Rating Scale (YMRS)
Description
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.
Time Frame
Day 1 and Day 168 or time of discontinuation
Secondary Outcome Measure Information:
Title
Clinical Global Impression - Bipolar Version (CGI-BP) Sevirity of Illness Score (Mania)
Description
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)
Time Frame
Day 1 and Daty 168 or time of discontinuation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsuhisa Saito
Organizational Affiliation
Department of Clinical Research and Development, Division of New Product Evaluation and Development
Official's Role
Study Director
Facility Information:
City
Chugoku region
Country
Japan
City
Hokuriku region
Country
Japan
City
Kanto region
Country
Japan
City
Kinki region
Country
Japan
City
Shikoku region
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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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