Abilify in Bipolar Disorder for 6 Weeks Treatment Effectiveness

Bipolar Disorder Clinical Trial

— SMART-A  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545142
• Other study ID #: 031-KOB-0701
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2007
• Last updated: June 24, 2010
• Start date: October 2007
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• 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 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.

Description:

Further study details as provided by Korea OIAA

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Abilify(Aripiprazole)
co-administration of Abilify with Depakote in the 6-week treatment of acute mania in patients with bipolar disorder
• Depakote(Divalproate)
co-administration of Abilify with Depakote in the 6-week treatment of acute 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	Changes in the YMRS total score from baseline to the end of 6-week study		Throughout the study	No
Secondary	Changes in YMRS total scores from baseline to the end of 6-week study		Throughout the study	No