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Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Adolescent Patients With Schizophrenia (ANCHOR 112)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00090324
First received: August 25, 2004
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Schizophrenia
 Drug: quetiapine fumarate tablets
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 3b Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets Compared With Placebo in Adolescents With Schizophrenia (Abbreviated)

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Compare efficacy of Quetiapine with placebo in the treatment of schizophrenia as assessed by the PANSS total score, change from baseline to Day 42

Secondary Outcome Measures:
  • Compare the effect of Quetiapine with placebo in change from baseline to Day 42 level of functioning, evaluate aggression and hostility; evaluate safety and tolerability

Estimated Enrollment: 249
Study Start Date: September 2004
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00090324

  Show 42 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Seroquel Medical Science Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00090324     History of Changes
Other Study ID Numbers: D1441C00112
Study First Received: August 25, 2004
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013