Abilify in Bipolar Disorder for 6 Weeks Treatment Effectiveness - Full Text View

Sponsored by:	Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by:	Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:	NCT00545142

Purpose

To demonstrate the efficacy and safety of co-administration of Abilify(aripiprazole) with Depakote(divalproate) in the acute phase of 6-week treatment of acute mania in patients with bipolar disorder.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Abilify(Aripiprazole) Drug: Depakote(Divalproate)	Phase IV

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Divalproex sodium Valproate Sodium Valproic acid Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Multi-Center, Single Arm, Open Phase IV Clinical Trial to Evaluate the Efficacy and Safety of co-Administration of Abilify With Depakote in the 6-Week Treatment of Acute Mania in Patients With Bipolar Disorder

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

Primary Outcome Measures:

Changes in the YMRS total score from baseline to the end of 6-week study [ Time Frame: Throughout the study ]

Secondary Outcome Measures:

Changes in YMRS total scores from baseline to the end of 6-week study [ Time Frame: Throughout the study ]

Estimated Enrollment:	280
Study Start Date:	October 2007

Detailed Description:

Further study details as provided by Korea OIAA

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Mania or mixed episode of Bipolar disorder Bipolar disorder, mania or mixed episode according to DSM-IV
The periods of mania or mixed episode should be within 3 months, and YMRS score at enrollment be more than 20.
Male and female between the age of 18 and 65 (In case of child-bearing women, negative pregnancy test results should be confirmed before the administration of the investigational drug and appropriate contraception be used. Pregnant and breast-feeding women cannot be included)
Patients who can consent to participate in this clinical trial
Patients who understand this trial and comply with all protocol requirements

Exclusion Criteria:

Patients with the following clinical symptoms diagnosed using DSM-IV:
- Delirium, dementia, amnestic or other cognitive disorders
- Schizophrenia or schizoaffective disorder
Patients who do not respond to clozapine
Patients who are expected to require the administration of prohibited concomitant drugs during the clinical trial period
Patients diagnosed with substance-related disorder according to DSM-IV within the past 3 months (abuse, intoxication, dependency and/or withdrawal symptoms). The abuse of benzodiazepines is included with the exception of caffeine or nicotine.
Patients known to have allergy or hypersensitivity reaction to Ablify(aripiprazole) or other quinolinones
Patients at high risk of suicide attempt or with the history of murder or mental status test
Patients with the history of neuroleptic malignant syndrome
Patients with the past history which may cause serious adverse events that can affect the safety or efficacy evaluation during the clinical trial period
Patients with vital sign or ECG results in the clinically significant abnormal laboratory test Patients with clinically significantly abnormal laboratory results, vital sign or ECG results
Pregnant women or child-bearing women who do not or cannot use appropriate contraception
Patients given psychotropic medications (except benzodiazepines) one day before baseline visit
Patients treated with Fluoxetine for the last 4 weeks
Patients who participated in clinical trials with other investigational drugs for the last one month
Patients with the history of convulsive disorder
Patients with the history of more than 4 mood episodes each year (rapid cycling) during the last 2 years prior to screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545142

Contacts

Contact: Yonghui Jeong	82-(0)2-3465-3954	jeongyh@otsuka.co.kr
Contact: Heather Yoo	82-(0)2-3451-6522	heatheryoo@otsukaoiaa.com

Locations

Korea, Republic of
St. Mary's hospital
Seoul, Korea, Republic of

Sponsors and Collaborators

Korea Otsuka Pharmaceutical Co.,Ltd.

Investigators

Principal Investigator:

Won-Myong Bahk, MD

St. Mary's hospital

More Information

Study ID Numbers:	031-KOB-0701
Study First Received:	October 16, 2007
Last Updated:	October 16, 2007
ClinicalTrials.gov Identifier:	NCT00545142
Health Authority:	Korea: IRB

Study placed in the following topic categories:

Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders

Psychotic Disorders
Aripiprazole
Valproic Acid

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors

Antipsychotic Agents
Antimanic Agents
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009