A Multicenter, Investigative Study of the Safety and Efficacy of Extended Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

NCT00606320 | Completed Phase 3 Results

• 1 other identifier: 031-06-005
• Study Type: interventional
• Target: 59
• Locations: 4 countries
• Sites: 12

Brief Summary

To assess the safety and efficacy of long-term administration of aripiprazole by performing extended administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner to those patients who completed the preceding multicenter, double-blind, placebo-controlled, parallel group-comparison trial of aripiprazole in patients with bipolar disorder experiencing a manic or mixed episode (Study 031-06-003, hereafter "Study 003") but whose condition worsened or remained unchanged or who discontinued Study 003 between Day 14 and Day 21 due to lack of drug efficacy.

Conditions

Bipolar I Disorder

Outcome Measures

Primary Outcomes (1)

• Young Mania Rating Scale (YMRS)

  YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) levated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior. YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome). Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated.

  baseline (Day 1 of preceding study), Day 154 or at discontinuation

Secondary Outcomes (1)

• Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)

  Baseline (Day 1 of preceding study) , Day 154 or at discontinuation

Study Arms (1)

Aripiprazole

EXPERIMENTAL

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

oral, 24mg(4 tablets)/day

Also known as: OPC-14597

Aripiprazole

Eligibility Criteria

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

You may qualify if:

• Trial subjects will be men and women of age 18 or above and below the age of 65 who will not be turning 65 during the trial.
• Subjects have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial.
• Subjects who meet DSM-IV-TR criteria for manic or mixed episodes and have been diagnosed as having "296.4x Bipolar I Disorder in which the most recent episode was manic" or "296.6x Bipolar I Disorder in which the most recent episode was mixed"
• Subjects who were enrolled in and have completed or withdrawn from Study 003 and who meet the following criteria
• Subjects who show exacerbation of condition or no change in condition: Those subjects who completed Study 003, and whose score for CGI-BP Change from preceding phase (mania) on Day 21 (completion of Study 003) was between 5 (Minimally worse) and 7 (Very much worse) (subjects showing exacerbation of condition), or whose score was 4 (No change) (subjects showing no change in condition)
• Subjects who discontinued due to lack of drug efficacy: Those subjects who discontinued Study 003 between Day 14 and Day 21, for whom the reason of withdrawal was lack of drug efficacy, and whose score for CGI-BP Change from preceding phase (mania) was between 5 (Minimally worse) and 7 (Very much worse)

You may not qualify if:

• Subjects presenting with a clinical picture and/or history that is consistent with a DSM-IV-TR diagnosis of:
• Delirium, dementia, amnestic disorder, or other cognitive disorders
• Schizophrenia or other psychotic disorder
• Personality disorder
• Subjects with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance
• Subjects who represent a significant risk of committing suicide
• Subjects known to have a complication of allergy to aripiprazole, other quinolinone-skeleton compounds, lithium, or valproate
• Subjects with a complication of neuroleptic malignant syndrome
• Subjects in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition
• Subjects with a complication of paralytic ileus
• Subjects with a complication of organic brain disorder or convulsive disorder, such as epilepsy
• Subjects with a complication of diabetes

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (12)

Unknown Facility

Hong Kong, China

Location

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Hokuriku Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Taipei, Taiwan

Location

MeSH Terms

Interventions

Aripiprazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Director of Clinical Research and Development
• Organization: Otsuka Pharmaceutical Co, Ltd.

+81-3-6361-7366

Study Officials

• Katsuhisa Saito

  Department of Clinical Research and Development, Division of New Product Evaluation and Development

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2008
• First Posted: February 1, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 12, 2014
• Results First Posted: February 12, 2014

Record last verified: 2014-01

Locations

JP (9); KR (1); TW (1); CN (1)