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Abilify in Bipolar Disorder for 6 Weeks Treatment Effectiveness (SMART-A)

Primary Purpose

Bipolar Disorder

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Abilify(Aripiprazole)

Depakote(Divalproate)

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Mania or mixed episode of Bipolar disorder Bipolar disorder, mania or mixed episode according to DSM-IV
The periods of mania or mixed episode should be within 3 months, and YMRS score at enrollment be more than 20.
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)
Patients who can consent to participate in this clinical trial
Patients who understand this trial and comply with all protocol requirements

Exclusion Criteria:

Patients with the following clinical symptoms diagnosed using DSM-IV:
- Delirium, dementia, amnestic or other cognitive disorders
- Schizophrenia or schizoaffective disorder
Patients who do not respond to clozapine
Patients who are expected to require the administration of prohibited concomitant drugs during the clinical trial period
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.
Patients known to have allergy or hypersensitivity reaction to Ablify(aripiprazole) or other quinolinones
Patients at high risk of suicide attempt or with the history of murder or mental status test
Patients with the history of neuroleptic malignant syndrome
Patients with the past history which may cause serious adverse events that can affect the safety or efficacy evaluation during the clinical trial period
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
Pregnant women or child-bearing women who do not or cannot use appropriate contraception
Patients given psychotropic medications (except benzodiazepines) one day before baseline visit
Patients treated with Fluoxetine for the last 4 weeks
Patients who participated in clinical trials with other investigational drugs for the last one month
Patients with the history of convulsive disorder
Patients with the history of more than 4 mood episodes each year (rapid cycling) during the last 2 years prior to screening.

Sites / Locations

St. Mary's hospital

Outcomes

Primary Outcome Measures

Changes in the YMRS total score from baseline to the end of 6-week study

Secondary Outcome Measures

Changes in YMRS total scores from baseline to the end of 6-week study

Full Information

NCT ID

NCT00545142

First Posted

October 16, 2007

Last Updated

June 24, 2010

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00545142

Brief Title

Abilify in Bipolar Disorder for 6 Weeks Treatment Effectiveness

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

Further study details as provided by Korea OIAA

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

280 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Abilify(Aripiprazole)

Intervention Description

co-administration of Abilify with Depakote in the 6-week treatment of acute mania in patients with bipolar disorder

Intervention Type

Drug

Intervention Name(s)

Depakote(Divalproate)

Intervention Description

co-administration of Abilify with Depakote in the 6-week treatment of acute mania in patients with bipolar disorder

Primary Outcome Measure Information:

Title

Changes in the YMRS total score from baseline to the end of 6-week study

Time Frame

Throughout the study

Secondary Outcome Measure Information:

Title

Changes in YMRS total scores from baseline to the end of 6-week study

Time Frame

Throughout the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Inclusion Criteria: Mania or mixed episode of Bipolar disorder Bipolar disorder, mania or mixed episode according to DSM-IV The periods of mania or mixed episode should be within 3 months, and YMRS score at enrollment be more than 20. 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) Patients who can consent to participate in this clinical trial Patients who understand this trial and comply with all protocol requirements Exclusion Criteria: Patients with the following clinical symptoms diagnosed using DSM-IV: Delirium, dementia, amnestic or other cognitive disorders Schizophrenia or schizoaffective disorder Patients who do not respond to clozapine Patients who are expected to require the administration of prohibited concomitant drugs during the clinical trial period 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. Patients known to have allergy or hypersensitivity reaction to Ablify(aripiprazole) or other quinolinones Patients at high risk of suicide attempt or with the history of murder or mental status test Patients with the history of neuroleptic malignant syndrome Patients with the past history which may cause serious adverse events that can affect the safety or efficacy evaluation during the clinical trial period 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 Pregnant women or child-bearing women who do not or cannot use appropriate contraception Patients given psychotropic medications (except benzodiazepines) one day before baseline visit Patients treated with Fluoxetine for the last 4 weeks Patients who participated in clinical trials with other investigational drugs for the last one month Patients with the history of convulsive disorder Patients with the history of more than 4 mood episodes each year (rapid cycling) during the last 2 years prior to screening.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Won-Myong Bahk, MD

Organizational Affiliation

St Mary's Hospital, London

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Mary's hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

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Abilify in Bipolar Disorder for 6 Weeks Treatment Effectiveness

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