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Phase 3 /Seroquel SR Acute Mania Monotherapy - US

NCT00422123 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 447

Last updated 2009-03-25

No results posted yet for this 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 Mania for 3 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

  • Affective Psychosis, Bipolar
  • Manic Disorder
  • Manic-Depressive Psychosis
  • Mania
  • Manic State
  • Psychoses, Manic-Depressive

Interventions

DRUG

Quetiapine fumarate (Seroquel) SR

Sponsors & Collaborators

Principal Investigators

  • Catherine Datto, MD · AstraZeneca

  • Larisa Acevedo, Ph.D · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Completion
2007-07-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00422123 on ClinicalTrials.gov