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

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

This study has been completed.

First Received: August 25, 2004 Last Updated: March 24, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00090324

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 III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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)

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:	July 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

Additional Information:

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	D1441C00112
Study First Received:	August 25, 2004
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00090324 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Schizophrenia

Study placed in the following topic categories:

Schizophrenia
Quetiapine
Tranquilizing Agents
Mental Disorders
Psychotropic Drugs

Central Nervous System Depressants
Psychotic Disorders
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Quetiapine
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 06, 2009