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OpenTrials
Completed

NCT Number: NCT00080314

Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode

The purpose of this study is to evaluate flexible doses (5-30mg) of aripiprazole versus placebo in patients with bipolar depression.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Consciousness Disorders Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Tuscaloosa, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

  • ages 18-65
  • Men and women, who have experienced a prior manic episode that required hospitalization, and now meet criteria for a major depressive episode.

Treatment and study plan

Aripiprazole

Drug

Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.

Other names: Abilify

Placebo

Drug

Tablets, Oral, 0 mg, Once daily, 8 weeks.

Primary outcomes

  1. Change on a depression rating scale at endpoint

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Mar 30, 2004
Registry last updated
Nov 11, 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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