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

August 25, 2004
January 3, 2013
September 2004
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Compare efficacy of Quetiapine with placebo in the treatment of schizophrenia as assessed by the PANSS total score, change from baseline to Day 42
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Complete list of historical versions of study NCT00090324 on ClinicalTrials.gov Archive Site
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
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Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Adolescent Patients With Schizophrenia
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)

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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Schizophrenia
Drug: quetiapine fumarate tablets
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
249
June 2007
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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
Both
13 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Ukraine,   Germany,   India,   Malaysia,   Philippines,   Poland,   Russian Federation,   Serbia,   South Africa
 
NCT00090324
D1441C00112
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AstraZeneca
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Study Director: Seroquel Medical Science Director, MD AstraZeneca
AstraZeneca
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP