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Study of Aripiprazole in Patients With Acute Bipolar Mania

NCT00097266 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 615

Last updated 2013-11-08

No results posted yet for this study

Summary

The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.

Conditions

Interventions

DRUG

Placebo

Tablets/capsules, oral, 0 mg, once daily, 3 weeks (switched to arm B for an additional 9 weeks).

DRUG

Aripiprazole

Tablets, oral, 15-30 mg, once daily, 12 weeks.

DRUG

Haloperidol

Capsule, oral, 5-15 mg, once daily, 12 weeks.

Sponsors & Collaborators

  • Otsuka America Pharmaceutical

    collaborator INDUSTRY

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2007-01-31
Completion
2007-01-31

Countries

  • United States
  • Bulgaria
  • Croatia
  • Mexico
  • Peru
  • Russia
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00097266 on ClinicalTrials.gov