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Completed

NCT Number: NCT00094432

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

The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.

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Key information

Conditions

Bipolar I Disorder Consciousness Disorders Mental 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, Mesa, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women, ages 18-65
  • Have experienced a prior manic episode that required treatment with a mood stabilizer or antipsychotic, 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. Mean change from baseline to endpoint on the MADRS total score.

Secondary outcomes

  1. Clinical Global Impression - Bipolar Version

  2. Severity of illness score depression

  3. Mean change from baseline to 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. CN138-146 LT is the 26-week Open Label Extension Phase of the Above Titled Protocol, CN138-146 ST.

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Oct 19, 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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