Abilify in Bipolar Disorder for 24 Weeks Treatment Effectiveness

NCT00545675 | Completed Phase 4

• 1 other identifier: 031-KOB-0702
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Time to recurrence of bipolar disorder from randomization

  Throughout the study

Study Arms (2)

1

EXPERIMENTAL

Abilify(aripiprazole) + Depakote(divalproate)

Drug: Abilify(aripiprazole)

2

PLACEBO COMPARATOR

Divalproate + Placebo

Drug: Depakote (divalproate)

Interventions

Abilify(aripiprazole) DRUG

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

1

Depakote (divalproate) DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mania or mixed episode of bipolar disorder according to DSM-IV
• 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
• 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)

You may not qualify if:

• 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
• 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 Abilify(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 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 with the history of convulsive disorder
• Patients judged to have decreased compliance to the investigational drugs during a 6-week trial period by an investigator
• Patients who commit serious protocol violation during a 6-week trial

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Won-Myong Bahk, MD

  St Mary's Hospital, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 17, 2007
• Study Start: December 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 12, 2010

Record last verified: 2009-12

Locations

KR (1)