A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

NCT00606281 | Completed Phase 3 Results

• 1 other identifier: 031-06-003
• Study Type: interventional
• Target: 258
• Locations: 4 countries
• Sites: 12

Brief Summary

The primary objective of this trial is to evaluate the clinical efficacy and safety of aripiprazole in comparison to placebo in patients with Bipolar I Disorder experiencing a manic or mixed episode.

Conditions

Bipolar I Disorder

Outcome Measures

Primary Outcomes (1)

• Young Mania Rating Scale (YMRS)

  Using LOCF datasets, change in YMRS total score from baseline (Day 1) to endpoint (Day 21) was evaluated through analysis of covariance(ANCOVA). 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) elevated 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).

  Day1, Day21

Secondary Outcomes (1)

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

  Day1, Day21

Study Arms (2)

1

EXPERIMENTAL

Drug: Aripiprazole

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

Aripiprazole DRUG

oral, 24mg/day

Also known as: OPC-14597

1

placebo DRUG

oral, 0mg(4tablets)/day

Also known as: OPC-14597

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:

• 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.
• Patients 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.
• Patients 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"
• Patients with a YMRS total score of 20 or more

You may not qualify if:

• Patients 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
• Patients experiencing their first manic or mixed episode
• Patients whose current manic episode has lasted for more than 4 weeks
• Patients with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance
• Patients who have met DSM-IV-TR criteria for a substance-related disorder within 3 months (90 days) prior to informed consent (excluding caffeine- and nicotine-related disorders, but including abuse of benzodiazepines)
• Patients who have received ECT treatment within 8 weeks prior to informed consent
• Patients who are expected to require administration of ultrashort-acting or short-acting benzodiazepine receptor agonist hypnotics and antianxiety drugs (See (1) of 4.2.2) at doses exceeding the equivalent of 15 mg/day of diazepam (Only for those patients using such drugs)
• Patients at significant risk of developing a severe adverse event. Patients who have a medical condition that would interfere with assessments of safety or efficacy during the course of the trial, or who have a history of such a condition.
• Patients who have received any of the following treatments during the screening period:
• Reserpine
• Levodopa, dopamine receptor stimulants
• Monoamine oxidase inhibitors

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• 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

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