A Multicenter, Placebo-Controlled, Double-Blind Investigative Extension Trial of the Safety and Efficacy of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

This study is currently recruiting participants.

Verified by Otsuka Pharmaceutical Co., Ltd., January 2009

First Received: January 19, 2008 Last Updated: January 8, 2009 History of Changes

Sponsored by:	Otsuka Pharmaceutical Co., Ltd.
Information provided by:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00606177

Purpose

To investigate the safety and efficacy of long-term administration of aripiprazole by performing extended administration of the treatment administered in 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") in a double-blind manner to those patients who complete Study 003 and demonstrate drug efficacy.

Condition	Intervention	Phase
Bipolar I Disorder	Drug: Aripiprazole Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Placebo-Controlled, Double-Blind Investigative Extension Trial of the Safety and Efficacy of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Aripiprazole

U.S. FDA Resources

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

Primary Outcome Measures:

Young Mania Rating Scale (YMRS) [ Time Frame: Pre, Week2, Week4, Week8, Week12, Week16, Week20, Week22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Global Impression - Bipolar Version (CGI-BP) [ Time Frame: Week2, Week4, Week8, Week12, Week16, Week20, Week22 ] [ Designated as safety issue: No ]

Estimated Enrollment:	44
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Aripiprazole oral, 24mg(4 tablets)/day
2: Placebo Comparator	Drug: placebo oral, 0mg(4tablets)/day

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.
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 Study 003 and who meet the following criteria for demonstration of drug efficacy
Subjects demonstrating drug efficacy:
- Those subjects who completed Study 003 whose score for CGI-BP Change From Preceding Phase (mania) at the time of evaluation on Day 21 of Study 003 (completion) was between 1 (Very much improved) and 3 (Minimally improved)

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 or other quinolinone-skeleton compounds
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606177

Contacts

Contact: Drug Information Center OPCJ

opc_ctr@otsuka.jp

Locations

China
	Recruiting
HongKong, China
Japan
	Recruiting
Hokkaido region, Japan
	Recruiting
Tohoku region, Japan
	Recruiting
Hokuriku region, Japan
	Recruiting
Chubu region, Japan
	Recruiting
Kanto region, Japan
	Recruiting
Kinki region, Japan
	Recruiting
Chugoku region, Japan
	Recruiting
Shikoku region, Japan
	Recruiting
Kyushu region, Japan
Korea, Republic of
	Recruiting
Seoul, Korea, Republic of
Taiwan
	Recruiting
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:	OPC-J ( Katsuhisa Saito )
Study ID Numbers:	031-06-004
Study First Received:	January 19, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00606177 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Affective Disorders, Psychotic
Tranquilizing Agents
Mental Disorders
Bipolar Disorder
Psychotropic Drugs

Mood Disorders
Central Nervous System Depressants
Psychotic Disorders
Aripiprazole
Antipsychotic Agents

Additional relevant MeSH terms:

Disease
Tranquilizing Agents
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions

Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Aripiprazole
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 03, 2009