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

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. According to ClinicalTrials.gov, the official US trial registry.

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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
AstraZeneca

1,285 total trials

What the finished NCT00422214 record still lists

NCT00422214 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 648-participant average among 5 other Depression, Bipolar trials with a reported enrollment target (38% lower).

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 names 20 study sites across 6 states, led by 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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Related registry views

Source: ClinicalTrials.gov NCT00422214, the US trial registry maintained by the National Library of Medicine. NCT00422214 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.