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NCT00422214 · ClinicalTrials.gov registry record · Phase 3

Phase III/Seroquel SR Bipolar Depression Monotherapy - US

A Phase 3 study of Depression, Bipolar and Affective Psychosis, Bipolar, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
400
Enrollment target
20
Study locations

NCT00422214 is a Phase 3 study of Depression, Bipolar and Affective Psychosis, Bipolar that has completed, run by AstraZeneca. The registered enrollment target is 400 participants, below the 648-participant average among 5 other Depression, Bipolar trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 6 states.

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The verdict

NCT00422214, a Phase 3 study of Depression, Bipolar and Affective Psychosis, Bipolar, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
400 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Depression, Bipolar Affective Psychosis, Bipolar Manic-Depressive Psychosis Psychoses, Manic-Depressive

Interventions

  • DRUG Quetiapine fumarate (Seroquel) SR

Study Locations (20)

California

  • Research Site - Cerritos
  • Research Site - La Mesa
  • Research Site - Los Angeles
  • Research Site - Newport Beach
  • Research Site - Northridge
  • Research Site - Oceanside
  • Research Site - Pico Rivera
  • Research Site - San Diego
  • Research Site - Wildomar

Florida

  • Research Site - Bradenton
  • Research Site - Fort Lauderdale
  • Research Site - Jacksonville
  • Research Site - Leesburg
  • Research Site - Maitland
  • Research Site - North Miami

Arizona

  • Research Site - Phoenix
  • Research Site - Scottsdale

Alabama

  • Research Site - Birmingham

Arkansas

  • Research Site - Little Rock

District of Columbia

  • Research Site - Washington D.C.

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2006-12
Est. Completion 2007-06
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00422214

The ClinicalTrials.gov registry entry for NCT00422214 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 648-participant average among 5 other Depression, Bipolar trials with a reported enrollment target (38% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Depression, Bipolar appearing as the primary indexed condition, and to 1 intervention - of which Quetiapine fumarate (Seroquel) SR is the first listed.

NCT00422214 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT00422214 about?

NCT00422214 is a clinical study titled "Phase III/Seroquel SR Bipolar Depression Monotherapy - US". 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...

What is the current status of trial NCT00422214?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2006-12. Estimated completion is 2007-06.

What conditions does trial NCT00422214 study?

This clinical trial studies the following conditions: Depression, Bipolar, Affective Psychosis, Bipolar, Manic-Depressive Psychosis, Psychoses, Manic-Depressive.

What interventions are being tested in trial NCT00422214?

The interventions under investigation include: Quetiapine fumarate (Seroquel) SR (DRUG).

Who is sponsoring clinical trial NCT00422214?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00422214 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.