COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00545675
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : August 12, 2010
Information provided by:
Korea Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Bipolar Disorder Drug: Abilify(aripiprazole) Drug: Depakote (divalproate) Phase 4

Detailed Description:
Further study details as provided by Korea OIAA

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Time to recurrence of bipolar disorder from randomization [ Time Frame: Throughout the study ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00545675

Layout table for location information
Korea, Republic of
St. Mary's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
Layout table for investigator information
Principal Investigator: Won-Myong Bahk, MD St Mary's Hospital, London
Layout table for additonal information
Responsible Party: Yonghui Jeong, Clinical Research Manager, Korea Otsuka Pharmaceutical Co.,Ltd. Identifier: NCT00545675    
Other Study ID Numbers: 031-KOB-0702
First Posted: October 17, 2007    Key Record Dates
Last Update Posted: August 12, 2010
Last Verified: December 2009
Additional relevant MeSH terms:
Layout table for MeSH terms
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Enzyme Inhibitors
GABA Agents
Antimanic Agents