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OpenTrials
Completed

NCT Number: NCT00257972

Study of Aripiprazole in Patients With Bipolar I Disorder

The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Epping, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of bipolar I disorder, manic or mixed episode

Exclusion criteria

  • First manic or mixed episode
  • Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole
  • Participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole

Treatment and study plan

Aripiprazole

Drug

Primary outcomes

  1. Change from baseline to endpoint in a mania rating scale

Secondary outcomes

  1. Response rate and Clinical Global Impression Scale at endpoint

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Collaborators

  • Otsuka America Pharmaceutical

Registry information

Official study title

Efficacy of Aripiprazole in Combination With Valproate or Lithium in the Treatment of Mania in Patients With Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Nov 24, 2005
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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