CClinicalTrials.gg
CompletedNCT00083954Updated Jan 4, 2013

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

A Phase 3 interventional study of Quetiapine Fumarate in Bipolar Disorder, sponsored by AstraZeneca. Completed at 36 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-01-04.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
530
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Bipolar Disorder

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Keywords

  • Bipolar I Disorder
03

In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's enrollment of 530 is above the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
530 participants

Interventions

  • DrugQuetiapine Fumarate
06

What researchers measure

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

07

Study locations

36 sites
  • Research Site
    Birmingham, Alabama, United States
  • Research Site
    Scottsdale, Arizona, United States
  • Research Site
    Cerritos, California, United States
  • Research Site
    Garden Grove, California, United States
  • Research Site
    San Diego, California, United States
  • Research Site
    Torrance, California, United States
  • Research Site
    Jacksonville, Florida, United States
  • Research Site
    Maitland, Florida, United States
  • Research Site
    Orlando, Florida, United States
  • Research Site
    Winter Park, Florida, United States
  • Research Site
    Boise, Idaho, United States
  • Research Site
    Oak Brook, Illinois, United States
  • Research Site
    Overbrook Terrace, Illinois, United States
  • Research Site
    Shreveport, Louisiana, United States
  • Research Site
    Baltimore, Maryland, United States
  • Research Site
    Clementon, New Jersey, United States
  • Research Site
    Moorestown, New Jersey, United States
  • Research Site
    Albuquerque, New Mexico, United States
  • Research Site
    Brooklyn, New York, United States
  • Research Site
    New York, New York, United States
  • Research Site
    Staten Island, New York, United States
  • Research Site
    Raleigh, North Carolina, United States
  • Research Site
    Cincinnati, Ohio, United States
  • Research Site
    Dayton, Ohio, United States
  • Research Site
    Oklahoma City, Oklahoma, United States
  • Research Site
    Portland, Oregon, United States
  • Research Site
    Philadelphia, Pennsylvania, United States
  • Research Site
    Pittsburgh, Pennsylvania, United States
  • Research Site
    Charleston, South Carolina, United States
  • Research Site
    Memphis, Tennessee, United States
  • Research Site
    Austin, Texas, United States
  • Research Site
    Houston, Texas, United States
  • Research Site
    Salt Lake City, Utah, United States
  • Research Site
    Bellevue, Washington, United States
  • Research Site
    Kirkland, Washington, United States
  • Research Site
    Seattle, Washington, United States
08

References and documents

Publications

  • Lydiard RB, Culpepper L, Schioler H, Gustafsson U, Paulsson B. Quetiapine monotherapy as treatment for anxiety symptoms in patients with bipolar depression: a pooled analysis of results from 2 double-blind, randomized, placebo-controlled studies. Prim Care Companion J Clin Psychiatry. 2009;11(5):215-25. doi: 10.4088/PCC.08m00659. PubMed 19956459 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00083954
Lead sponsor
AstraZeneca
First posted
Jun 7, 2004
Start date
Jun 2004
Completion
Aug 2005
Last update
Jan 4, 2013

Study contacts

AstraZeneca Seroquel Medical Science Director, MD
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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