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Completed

NCT Number: NCT00083954

Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression

The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of informed consent before enrollment and any study-specific procedures. Patients deemed incapable of providing written consent will not be enrolled in this study; outpatient status

Exclusion criteria

  • More than 8 mood episodes in the past year from screen (visit 1);
  • A current Axis I disorder other than bipolar disorder within 6 months of screening;
  • patients with clinically significant abnormal laboratory findings in the investigator's judgment

Treatment and study plan

Quetiapine fumarate

Drug

Primary outcomes

  1. Change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score

Secondary outcomes

  1. Evaluate the incidence of treatment-emergent mania compared to placebo

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Confirmatory Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Use of Quetiapine Fumarate (SEROQUEL) in the Treatment of Patients With Bipolar Depression

Important dates

Study start
2004
Study completion
2005
First posted
Jun 7, 2004
Registry last updated
Jan 4, 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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