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
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Drug: Abilify(Aripiprazole)
Drug: Depakote(Divalproate)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Changes in YMRS total scores from baseline to the end of 6-week study [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: October 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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:

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.
  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: NCT00545142

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: Jeong, Yonghui, Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00545142     History of Changes
Other Study ID Numbers: 031-KOB-0701
Study First Received: October 16, 2007
Last Updated: June 24, 2010
Health Authority: Korea: IRB

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

ClinicalTrials.gov processed this record on October 21, 2014