Status:

COMPLETED

Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Adolescent Patients With Schizophrenia

Lead Sponsor:

AstraZeneca

Conditions:

Schizophrenia

Eligibility:

All Genders

13-17 years

Phase:

PHASE3

Brief Summary

The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of adolescent patients with schizophrenia.

Eligibility Criteria

Inclusion

  • Patient is able to provide written assent and the parents or legal guardian of the patient is able to provide written informed consent before beginning and study related procedures
  • Patient has a documented clinical diagnosis of schizophrenia
  • Patient's parent or legal guardian will be able to accompany the patient at each scheduled study visit

Exclusion

  • Patients (female) must not be pregnant or lactating
  • Patients with a known intolerance or lack of response to previous treatment with quetiapine
  • Patients who have previously participated in this study

Key Trial Info

Start Date :

September 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2007

Estimated Enrollment :

249 Patients enrolled

Trial Details

Trial ID

NCT00090324

Start Date

September 1 2004

End Date

June 1 2007

Last Update

January 4 2013

Active Locations (42)

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Page 1 of 11 (42 locations)

1

Research Site

Dothan, Alabama, United States

2

Research Site

Cerritos, California, United States

3

Research Site

Riverside, California, United States

4

Research Site

Sacramento, California, United States