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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:
ClinicalTrials.gov Identifier:
NCT00090324
First Posted: August 30, 2004
Last Update Posted: January 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
August 25, 2004
August 30, 2004
January 4, 2013
September 2004
Not Provided
Compare efficacy of Quetiapine with placebo in the treatment of schizophrenia as assessed by the PANSS total score, change from baseline to Day 42
Not Provided
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Schizophrenia
Drug: quetiapine fumarate tablets
Not Provided
Findling RL, McKenna K, Earley WR, Stankowski J, Pathak S. Efficacy and safety of quetiapine in adolescents with schizophrenia investigated in a 6-week, double-blind, placebo-controlled trial. J Child Adolesc Psychopharmacol. 2012 Oct;22(5):327-42. doi: 10.1089/cap.2011.0092.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
249
June 2007
Not Provided

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
Sexes Eligible for Study: All
13 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   India,   Malaysia,   Philippines,   Poland,   Russian Federation,   Serbia,   South Africa,   Ukraine,   United States
Former Serbia and Montenegro
 
NCT00090324
D1441C00112
Not Provided
Not Provided
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AstraZeneca
Not Provided
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