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

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

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.

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder
• Intervention / Treatment: Drug: Abilify(Aripiprazole); Drug: Depakote(Divalproate)

Detailed Description

Further study details as provided by Korea OIAA

• Study Type: Interventional
• Enrollment (Anticipated): 280
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in the YMRS total score from baseline to the end of 6-week study	Throughout the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in YMRS total scores from baseline to the end of 6-week study	Throughout the study

Collaborators and Investigators

• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Won-Myong Bahk, MD, St Mary's Hospital, London

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: October 16, 2007
• First Submitted That Met QC Criteria: October 16, 2007
• First Posted (Estimate): October 17, 2007

Study Record Updates

• Last Update Posted (Estimate): June 25, 2010
• Last Update Submitted That Met QC Criteria: June 24, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Bipolar and Related Disorders; Bipolar Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; GABA Agents; Anticonvulsants; Antimanic Agents; Aripiprazole; Valproic Acid
• Other Study ID Numbers: 031-KOB-0701