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Study Evaluating the Clinical Benefit of SEROQUEL XR in Subjects With Schizophrenia

NCT00640601 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 331

Last updated 2012-06-25

Study results available
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Summary

A Multicentre, Open-label, Prospective Long-term Study Evaluating the Clinical Benefit and Effectiveness of SEROQUEL XR® (Quetiapine Fumarate Extended-Release Tablets) in Subjects with Schizophrenia.

Conditions

Interventions

DRUG

Quetiapine Fumarate Extended- Release

Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.

Sponsors & Collaborators

Principal Investigators

  • Pierre Chue, MD · University of Alberta

  • Willie Early, MD · AstraZeneca

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Australia
  • Canada
  • Hong Kong
  • South Korea

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 NCT00640601 on ClinicalTrials.gov