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OpenTrials
Completed

NCT Number: NCT00226317

Aripiprazole in the Treatment of Bipolar Depression

A systematic open-label prospective pilot study to assess aripirazole for acute bipolar depression, with a secondary assessment of longer-term mood stabilization.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

About this study

Study is 6 weeks long with 7 clinical visits.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • DSM-IV diagnosis of bipolar disorder, any subtype; MADRS >16; MRS < 10; not currently taking other mood stabilizers; women of reproductive potential must use an acceptable method of birth control

Exclusion criteria

  • Current substance abuse within past month; serious unstable medical condition; active suicidal ideation; pregnant, trying to become pregnant, or nursing; intent to continue or initiate herbal preparations

Treatment and study plan

Aripiprazole

Drug

Primary outcomes

  1. Depression state

    Time frame: 6 week study

Sponsors and collaborators

Lead sponsor

Cambridge Health Alliance

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

Phase 4 Study: An Open Prospective Study of the Safety and Effectiveness of Aripiprazole in the Treatment of Bipolar Depression

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Sep 27, 2005
Registry last updated
Apr 18, 2017

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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