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Clinical Trials/NCT00422214
NCT00422214CompletedPhase 3

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel SR®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Depression

AstraZeneca54 sites in 1 country400 target enrollmentStarted: December 1, 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
400
Locations
54
Primary Endpoint
Change from baseline in depression symptoms by final visit as measured by the MADRS total score
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression for 8 weeks.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Provision of written informed consent
  • •Documented diagnosis of Bipolar 1 disorder or Bipolar 11 disorder
  • •Outpatient status at enrollment

Exclusion Criteria

  • •Patients with >8 mood episodes during the past 12 years
  • •Use of prohibited medications
  • •Substance or alcohol abuse or dependence
  • •Current suicide risk or suicide attempt within last 6 months.

Outcomes

Primary Outcomes

Change from baseline in depression symptoms by final visit as measured by the MADRS total score

Secondary Outcomes

  • Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C

Investigators

Sponsor Class
Industry

Study Sites (54)

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