Abilify in Bipolar Disorder for 24 Weeks Treatment Effectiveness

Bipolar Disorder Clinical Trial

— SMART-M  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545675
• Other study ID #: 031-KOB-0702
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2007
• Last updated: August 10, 2010
• Start date: December 2007
• Est. completion date: July 2010

Study information

• Verified date: December 2009
• Source: Korea Otsuka Pharmaceutical Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: IRB
• Study type: Interventional

Clinical Trial 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

Description:

Further study details as provided by Korea OIAA

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Abilify(aripiprazole)
Abilify and Depakote in 24-week treatment of mania in patients with bipolar disorder
• Depakote (divalproate)
Placebo and Depakote in 24-week treatment of mania in patients with bipolar disorder

Locations

Country	Name	City	State
Korea, Republic of	St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recurrence of bipolar disorder from randomization		Throughout the study	No