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Abilify in Bipolar Disorder for 24 Weeks Treatment Effectiveness (SMART-M)
This study is not yet open for participant recruitment.
Verified by Korea Otsuka Pharmaceutical Co.,Ltd., October 2007
First Received: October 16, 2007   No Changes Posted
Sponsored by: Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by: Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00545675
  Purpose

To demonstrate the difference between Abilify with Depakote vs. Placebo with Depakote in 24-week treatment in patients with remission status after Abilify with Depakote in the 6-week study 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 Valproic acid Aripiprazole Valproate Sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Multi-Center, Double-Blind, Randomized, Comparative Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of co-Administration of Abilify and Depakote in 24-Week Treatment of Mania in Patients With Bipolar Disorder Remitted After 6-Week Treatment With Abilify and Depakote

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

Primary Outcome Measures:
  • Time to recurrence of bipolar disorder from randomization [ Time Frame: Throughout the study ]

Estimated Enrollment: 146
Study Start Date: November 2007
Arms Assigned Interventions
1: Experimental
Abilify(aripiprazole) + Depakote(divalproate)
Drug: Abilify(aripiprazole) Drug: Depakote (divalproate)
2: Placebo Comparator
Divalproate + Placebo
Drug: Depakote (divalproate)

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:

  1. Mania or mixed episode of bipolar disorder according to DSM-IV
  2. 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)
  3. Patients who can consent to participate in this clinical trial
  4. Patients who understand this trial and comply with all protocol requirements
  5. Patients who fulfill the following remission criteria for bipolar disorder in the two consecutive evaluation performed every week at Week 6 of 6-week study and thereafter: (Definition of remission: a score less than 12 on the YMRS total score and simultaneously a score less than 13 on the MADRS total score)

Exclusion Criteria:

  1. Patients with the following clinical symptoms diagnosed using DSM-1. Patients with the following clinical symptoms diagnosed using DSM-IV:

    • Delirium, dementia, amnestic or other cognitive disorders
    • Schizophrenia or schizoaffective disorder
  2. Patients who do not respond to clozapine
  3. Patients who are expected to require the administration of prohibited concomitant drugs during the clinical trial period
  4. 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.
  5. Patients known to have allergy or hypersensitivity reaction to Abilify(aripiprazole) or other quinolinones
  6. Patients at high risk of suicide attempt or with the history of murder or mental status test
  7. Patients with the history of neuroleptic malignant syndrome
  8. Patients with the past history which may cause serious adverse events that can affect the safety or efficacy evaluation during the clinical trial period
  9. Patients with clinically significantly abnormal laboratory results, vital sign or ECG results
  10. Pregnant women or child-bearing women who do not or cannot use appropriate contraception
  11. Patients with the history of convulsive disorder
  12. Patients judged to have decreased compliance to the investigational drugs during a 6-week trial period by an investigator
  13. Patients who commit serious protocol violation during a 6-week trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545675

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

No publications provided

Study ID Numbers: 031-KOB-0702
Study First Received: October 16, 2007
Last Updated: October 16, 2007
ClinicalTrials.gov Identifier: NCT00545675     History of Changes
Health Authority: Korea: IRB

Study placed in the following topic categories:
Neurotransmitter Agents
Tranquilizing Agents
Bipolar Disorder
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Antimanic Agents
Valproic Acid
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Psychotic Disorders
Aripiprazole
Anticonvulsants

Additional relevant MeSH terms:
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Antipsychotic Agents
Antimanic Agents
Valproic Acid
Pharmacologic Actions
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
GABA Agents
Aripiprazole
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 06, 2009