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Quetiapine Fumarate Bipolar Maintenance Monotherapy

NCT00314184 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1255

Last updated 2008-12-22

No results posted yet for this study

Summary

This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Conditions

Interventions

DRUG

quetiapine fumarate

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca CNS Medical Science Director, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Completion
2007-07-31

Countries

  • United States
  • Argentina
  • Bulgaria
  • Colombia
  • India
  • Lithuania
  • Malaysia
  • Mexico
  • Peru
  • Philippines
  • Romania
  • Russia
  • Taiwan
  • Thailand
  • Ukraine

Study Locations

More Related Trials

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 NCT00314184 on ClinicalTrials.gov