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A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania

NCT00261443 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1270

Last updated 2023-04-18

Study results available
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Summary

The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate.

Conditions

Interventions

DRUG

Lithium or Valproate with placebo (PBO)

Tablets, Oral, once daily lithium 250-2100 mg/day valproate 250-2500mg/day Placebo once daily

DRUG

Lithium or Valproate with Aripiprazole

Tablets, Oral, once daily, 52 weeks post randomization (Pre-Randomization Phases 13-24 weeks) lithium 250-2100 mg/day valproate 250-2500mg/day aripiprazole 15-30 mg/day

Sponsors & Collaborators

  • 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
2005-09-30
Primary Completion
2009-06-30
Completion
2009-10-31

Countries

  • United States
  • Brazil
  • Bulgaria
  • Croatia
  • Czechia
  • France
  • India
  • Russia
  • South Africa

Study Locations

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Entities

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 NCT00261443 on ClinicalTrials.gov