Abilify in Bipolar Disorder for 24 Weeks Treatment Effectiveness

NCT ID: NCT00545675

Last Updated: 2010-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2010-07-31

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

Detailed Description

Further study details as provided by Korea OIAA

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Abilify(aripiprazole) + Depakote(divalproate)

Group Type: EXPERIMENTAL

Abilify(aripiprazole)

Intervention Type: DRUG

Abilify and Depakote in 24-week treatment of mania in patients with bipolar disorder

2

Divalproate + Placebo

Group Type: PLACEBO_COMPARATOR

Depakote (divalproate)

Intervention Type: DRUG

Placebo and Depakote in 24-week treatment of mania in patients with bipolar disorder

Interventions

Abilify(aripiprazole)

Abilify and Depakote in 24-week treatment of mania in patients with bipolar disorder

Intervention Type: DRUG

Depakote (divalproate)

Placebo and Depakote in 24-week treatment of mania in patients with bipolar disorder

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Korea Otsuka Pharmaceutical Co.,Ltd.

Principal Investigators

Won-Myong Bahk, MD

Role: PRINCIPAL_INVESTIGATOR

St Mary's Hospital, London

Locations

St. Mary's Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

031-KOB-0702

Identifier Type: -

Identifier Source: org_study_id