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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Korea OIAA

Intervention(s) in this Clinical Trial

• Drug: Abilify(aripiprazole)
• Drug: Depakote (divalproate)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Abilify(aripiprazole) + Depakote(divalproate)
• Placebo Comparator: 2
  • Divalproate + Placebo

Primary Measures

• Time to recurrence of bipolar disorder from randomization
  • Time Frame: Throughout the study
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Korea Otsuka Pharmaceutical Co.,Ltd.

Overall Clinical Trial Officials and Contacts

Won-Myong Bahk, MD Principal Investigator St. Mary's hospital  

Overall Contact: Yonghui Jeong 82-(0)2-3465-3954 jeongyh@otsuka.co.kr

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00545675

Study ID Number: 031-KOB-0702

ClinicalTrials.gov Identifier: NCT00545675

Health Authority: Korea: IRB