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

NCT ID: NCT00606320

Last Updated: 2014-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-11-30

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.

Conditions

Bipolar I Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aripiprazole

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

oral, 24mg(4 tablets)/day

Interventions

Aripiprazole

oral, 24mg(4 tablets)/day

Intervention Type: DRUG

Other Intervention Names

OPC-14597

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• Subjects who were enrolled in and have completed or withdrawn from Study 003 and who meet the following criteria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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katsuhisa Saito

Role: STUDY_DIRECTOR

Department of Clinical Research and Development, Division of New Product Evaluation and Development

Locations

Hong Kong, , China

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

Seoul, , South Korea

Taipei, , Taiwan

Countries

China; Japan; South Korea; Taiwan

Other Identifiers

031-06-005

Identifier Type: -

Identifier Source: org_study_id