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Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar Depression

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00060489
Enrollment
Unknown
Registered
2003-05-08
Start date
2002-09-30
Completion date
2003-09-30
Last updated
2011-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Depression, Bipolar

Keywords

Bipolar Depression

Brief summary

The purpose of this study is to evaluate the efficacy and safety of quetiapine in the treatment of a major depressive episode in patients with bipolar disorder.

Interventions

DRUGSEROQUEL (quetiapine fumarate) Tablets

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Written Informed Consent; * Bipolar disorder with most recent episode depressed; * Outpatient status

Exclusion criteria

* Patients with a current Axis I disorder other than bipolar disorder within 6 months of screening; * Patients whose current episode of depression exceeds 12 months or is less than 4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026