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Abilify in Bipolar Disorder for 6 Weeks Treatment Effectiveness (SMART-A)

This study has been completed.
Sponsor:
Information provided by:
Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00545142
First received: October 16, 2007
Last updated: June 24, 2010
Last verified: June 2010

October 16, 2007
June 24, 2010
October 2007
June 2010   (final data collection date for primary outcome measure)
Changes in the YMRS total score from baseline to the end of 6-week study [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Changes in the YMRS total score from baseline to the end of 6-week study [ Time Frame: Throughout the study ]
Complete list of historical versions of study NCT00545142 on ClinicalTrials.gov Archive Site
Changes in YMRS total scores from baseline to the end of 6-week study [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Changes in YMRS total scores from baseline to the end of 6-week study [ Time Frame: Throughout the study ]
Not Provided
Not Provided
 
Abilify in Bipolar Disorder for 6 Weeks Treatment Effectiveness
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

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.

Further study details as provided by Korea OIAA

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: Abilify(Aripiprazole)
    co-administration of Abilify with Depakote in the 6-week treatment of acute mania in patients with bipolar disorder
  • Drug: Depakote(Divalproate)
    co-administration of Abilify with Depakote in the 6-week treatment of acute mania in patients with bipolar disorder
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

Inclusion Criteria:

  1. Mania or mixed episode of Bipolar disorder Bipolar disorder, mania or mixed episode according to DSM-IV
  2. The periods of mania or mixed episode should be within 3 months, and YMRS score at enrollment be more than 20.
  3. 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)
  4. Patients who can consent to participate in this clinical trial
  5. Patients who understand this trial and comply with all protocol requirements

Exclusion Criteria:

  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 Ablify(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 vital sign or ECG results in the clinically significant abnormal laboratory test 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 given psychotropic medications (except benzodiazepines) one day before baseline visit
  12. Patients treated with Fluoxetine for the last 4 weeks
  13. Patients who participated in clinical trials with other investigational drugs for the last one month
  14. Patients with the history of convulsive disorder
  15. Patients with the history of more than 4 mood episodes each year (rapid cycling) during the last 2 years prior to screening.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00545142
031-KOB-0701
No
Jeong, Yonghui, Korea Otsuka Pharmaceutical Co.,Ltd.
Korea Otsuka Pharmaceutical Co.,Ltd.
Not Provided
Principal Investigator: Won-Myong Bahk, MD St Mary's Hospital, London
Korea Otsuka Pharmaceutical Co.,Ltd.
June 2010

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