Abilify in Bipolar Disorder for 24 Weeks Treatment Effectiveness (SMART-M)

This study has been completed.
Sponsor:
Information provided by:
Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00545675
First received: October 16, 2007
Last updated: August 10, 2010
Last verified: December 2009

October 16, 2007
August 10, 2010
December 2007
July 2010   (final data collection date for primary outcome measure)
Time to recurrence of bipolar disorder from randomization [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Time to recurrence of bipolar disorder from randomization [ Time Frame: Throughout the study ]
Complete list of historical versions of study NCT00545675 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Abilify in Bipolar Disorder for 24 Weeks Treatment Effectiveness
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

Further study details as provided by Korea OIAA

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: Abilify(aripiprazole)
    Abilify and Depakote in 24-week treatment of mania in patients with bipolar disorder
  • Drug: Depakote (divalproate)
    Placebo and Depakote in 24-week treatment of mania in patients with bipolar disorder
  • Experimental: 1
    Abilify(aripiprazole) + Depakote(divalproate)
    Intervention: Drug: Abilify(aripiprazole)
  • Placebo Comparator: 2
    Divalproate + Placebo
    Intervention: Drug: Depakote (divalproate)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00545675
031-KOB-0702
No
Yonghui Jeong, Clinical Research Manager, Korea Otsuka Pharmaceutical Co.,Ltd.
Korea Otsuka Pharmaceutical Co.,Ltd.
Not Provided
Principal Investigator: Won-Myong Bahk, MD St. Mary's Hospital
Korea Otsuka Pharmaceutical Co.,Ltd.
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP