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OpenTrials
Completed

NCT Number: NCT00097266

Study of Aripiprazole in Patients With Acute Bipolar Mania

The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.

Completed

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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, Burgas, Bulgaria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.

Treatment and study plan

Placebo

Drug

Tablets/capsules, oral, 0 mg, once daily, 3 weeks (switched to arm B for an additional 9 weeks).

Aripiprazole

Drug

Tablets, oral, 15-30 mg, once daily, 12 weeks.

Other names: Abilify

Haloperidol

Drug

Capsule, oral, 5-15 mg, once daily, 12 weeks.

Primary outcomes

  1. Change in a mania 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 Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Nov 22, 2004
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.

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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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