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A Multicenter, Investigative Study of the Safety and Efficacy of Extended 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
International
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.
  • Subjects 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.
  • Subjects 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"

  • Subjects who were enrolled in and have completed or withdrawn from Study 003 and who meet the following criteria

    • Subjects who show exacerbation of condition or no change in condition: Those subjects who completed Study 003, and whose score for CGI-BP Change from preceding phase (mania) on Day 21 (completion of Study 003) was between 5 (Minimally worse) and 7 (Very much worse) (subjects showing exacerbation of condition), or whose score was 4 (No change) (subjects showing no change in condition)
    • Subjects who discontinued due to lack of drug efficacy: Those subjects who discontinued Study 003 between Day 14 and Day 21, for whom the reason of withdrawal was lack of drug efficacy, and whose score for CGI-BP Change from preceding phase (mania) was between 5 (Minimally worse) and 7 (Very much worse)

Exclusion Criteria:

  • Subjects 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
  • Subjects with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance
  • Subjects who represent a significant risk of committing suicide
  • Subjects known to have a complication of allergy to aripiprazole, other quinolinone-skeleton compounds, lithium, or valproate
  • Subjects with a complication of neuroleptic malignant syndrome
  • Subjects in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition
  • Subjects with a complication of paralytic ileus
  • Subjects with a complication of organic brain disorder or convulsive disorder, such as epilepsy
  • Subjects with a complication of diabetes

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aripiprazole

Arm Description

Outcomes

Primary Outcome Measures

Young Mania Rating Scale (YMRS)
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) levated 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). Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated.

Secondary Outcome Measures

Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)
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, descriptive statistics of actual values for change of CGI-BP severity of illness score (mania) from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated for each treatment group.

Full Information

First Posted
January 19, 2008
Last Updated
January 16, 2014
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00606320
Brief Title
A Multicenter, Investigative Study of the Safety and Efficacy of Extended 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 Extended 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
January 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 by performing extended administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner to those patients who completed the preceding multicenter, double-blind, placebo-controlled, parallel group-comparison trial of aripiprazole in patients with bipolar disorder experiencing a manic or mixed episode (Study 031-06-003, hereafter "Study 003") but whose condition worsened or remained unchanged or who discontinued Study 003 between Day 14 and Day 21 due to lack of drug efficacy.

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
Non-Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
OPC-14597
Intervention Description
oral, 24mg(4 tablets)/day
Primary Outcome Measure Information:
Title
Young Mania Rating Scale (YMRS)
Description
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) levated 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). Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated.
Time Frame
baseline (Day 1 of preceding study), Day 154 or at discontinuation
Secondary Outcome Measure Information:
Title
Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)
Description
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, descriptive statistics of actual values for change of CGI-BP severity of illness score (mania) from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated for each treatment group.
Time Frame
Baseline (Day 1 of preceding study) , Day 154 or at 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. Subjects 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. Subjects 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" Subjects who were enrolled in and have completed or withdrawn from Study 003 and who meet the following criteria Subjects who show exacerbation of condition or no change in condition: Those subjects who completed Study 003, and whose score for CGI-BP Change from preceding phase (mania) on Day 21 (completion of Study 003) was between 5 (Minimally worse) and 7 (Very much worse) (subjects showing exacerbation of condition), or whose score was 4 (No change) (subjects showing no change in condition) Subjects who discontinued due to lack of drug efficacy: Those subjects who discontinued Study 003 between Day 14 and Day 21, for whom the reason of withdrawal was lack of drug efficacy, and whose score for CGI-BP Change from preceding phase (mania) was between 5 (Minimally worse) and 7 (Very much worse) Exclusion Criteria: Subjects 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 Subjects with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance Subjects who represent a significant risk of committing suicide Subjects known to have a complication of allergy to aripiprazole, other quinolinone-skeleton compounds, lithium, or valproate Subjects with a complication of neuroleptic malignant syndrome Subjects in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition Subjects with a complication of paralytic ileus Subjects with a complication of organic brain disorder or convulsive disorder, such as epilepsy Subjects with 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
HongKong
Country
China
City
Chubu region
Country
Japan
City
Chugoku region
Country
Japan
City
Hokkaido region
Country
Japan
City
Hokuriku region
Country
Japan
City
Kanto region
Country
Japan
City
Kinki region
Country
Japan
City
Kyushu region
Country
Japan
City
Shikoku region
Country
Japan
City
Tohoku region
Country
Japan
City
Seoul
Country
Korea, Republic of
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

A Multicenter, Investigative Study of the Safety and Efficacy of Extended 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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