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Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder

NCT00665366 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 493

Last updated 2013-12-02

Study results available
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Summary

The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.

Conditions

  • Bipolar Disorder Mania

Interventions

DRUG

Aripiprazole

5-, 10-, or 15-mg oral tablets in titrated doses for 12 weeks

DRUG

Placebo

Tablets, Oral, 0 mg, once daily, 12 weeks

DRUG

Lithium

Participant's ongoing dose

DRUG

Valproate

Participant's ongoing dose

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
2008-06-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Austria
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Poland
  • Romania
  • Russia
  • South Africa
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

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 NCT00665366 on ClinicalTrials.gov