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 - Full Text View

Sponsored by:	Otsuka Pharmaceutical Co., Ltd.
Information provided by:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00606229

Purpose

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

Condition	Intervention	Phase
Bipolar I Disorder	Drug: Aripiprazole	Phase III

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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

Primary Outcome Measures:

Young Mania Rating Scale (YMRS) [ Time Frame: Pre, Week2, Weeek4, Week8, Week12, Week16, Week20, Week24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Global Impression - Bipolar Version (CGI-BP) [ Time Frame: Week2, Weeek4, Week8, Week12, Week16, Week20, Week24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
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/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.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606229

Contacts

Contact: Drug Information Center OPCJ

opc_ctr@otsuka.jp

Locations

Japan
	Recruiting
Kanto region, Japan
	Recruiting
Hokuriku region, Japan
	Recruiting
Kinki region, Japan
	Recruiting
Chugoku region, Japan
	Recruiting
Shikoku region, Japan

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

Responsible Party:	OPC-J ( Katsuhisa Saito )
Study ID Numbers:	031-07-001
Study First Received:	January 19, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00606229
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder

Mood Disorders
Psychotic Disorders
Aripiprazole

Additional relevant MeSH terms:

Tranquilizing Agents
Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009