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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 146
Study Start Date: December 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Abilify(aripiprazole) + Depakote(divalproate)
Drug: Abilify(aripiprazole)
Abilify and Depakote in 24-week treatment of mania in patients with bipolar disorder
Placebo Comparator: 2
Divalproate + Placebo
Drug: Depakote (divalproate)
Placebo and Depakote in 24-week treatment of mania in patients with bipolar disorder

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545675

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, London
  More Information

No publications provided

Responsible Party: Yonghui Jeong, Clinical Research Manager, Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00545675     History of Changes
Other Study ID Numbers: 031-KOB-0702
Study First Received: October 16, 2007
Last Updated: August 10, 2010
Health Authority: Korea: IRB

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

ClinicalTrials.gov processed this record on August 27, 2014