Abilify in Bipolar Disorder for 6 Weeks Treatment Effectiveness

NCT00545142 | Completed Phase 4

• 1 other identifier: 031-KOB-0701
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

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

  Throughout the study

Secondary Outcomes (1)

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

  Throughout the study

Interventions

Abilify(Aripiprazole) DRUG

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

Depakote(Divalproate) DRUG

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

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

St. Mary's hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Won-Myong Bahk, MD

  St Mary's Hospital, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 17, 2007
• Study Start: October 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 25, 2010

Record last verified: 2010-06

Locations

KR (1)