Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in Acute Schizophrenic Patients - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00254787

Purpose

The purpose of the study is to compare the safety and tolerability of IR (Immediate-Release) quetiapine in a rapid escalation scheme with to the current approved label titration.

Condition	Intervention	Phase
Schizophrenia	Drug: IR (Immediate-Release) quetiapine fumarate (drug)	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, Dose Comparison, Parallel Assignment, Safety Study
Official Title:	Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in the Treatment of Patients With Acute Schizophrenia – a Multicentre, Double-Blind, Parallel Group, Randomized Study

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Proportion of patients who discontinue the study treatment due to adverse events (AEs) during the first week (day 1 to day 7) of treatment

Secondary Outcome Measures:

Safety and Tolerability
Number and type of adverse events
Changes in vital signs and weight
Clinically significant changes in ECG (reported as AE)
Change of Simpson-Angus Scale (SAS) score
Change of Barnes Akathisia Rating Scale (BARS) score

Estimated Enrollment:	30
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women age ≥18 to ≤65 years with acute schizophrenia
Provision of written informed consent prior to enrolment

Exclusion Criteria:

Meeting the criteria for any other (than schizophrenia) psychotic disorder not in full remission, concomitant organic mental disorder or mental retardation
Patients with substance dependence
Female patients who are pregnant, lactating or at risk of pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254787

Locations

Germany
Research Site
Essen, Germany
Research Site
Hamburg, Germany
Research Site
Jena, Germany
Research Site
Cologne, Germany
Research Site
Berlin, Germany
Research Site
Werneck, Germany

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Germany Medical Director

AstraZeneca

More Information

Study ID Numbers:	D1441L00032, RACE, EudraCT-No. 2004-005122-45
Study First Received:	November 15, 2005
Last Updated:	November 1, 2006
ClinicalTrials.gov Identifier:	NCT00254787
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

Schizophrenia

Study placed in the following topic categories:

Schizophrenia
Quetiapine
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009