Abilify in Bipolar Disorder for 24 Weeks Treatment Effectiveness (SMART-M)

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

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

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): 146
• 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: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Abilify(aripiprazole) + Depakote(divalproate)	Drug: Abilify(aripiprazole); Abilify and Depakote in 24-week treatment of mania in patients with bipolar disorder
Placebo Comparator: 2; Divalproate + Placebo	Drug: Depakote (divalproate); Placebo and Depakote in 24-week treatment of mania in patients with bipolar disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to recurrence of bipolar disorder from randomization	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: December 1, 2007
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 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): August 12, 2010
• Last Update Submitted That Met QC Criteria: August 10, 2010
• Last Verified: December 1, 2009

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-0702