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Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in Acute Schizophrenic Patients

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.
ClinicalTrials.gov Identifier: NCT00254787
Recruitment Status : Completed
First Posted : November 17, 2005
Last Update Posted : June 11, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Drug: IR (Immediate-Release) quetiapine fumarate (drug) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : June 2005
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. Safety and Tolerability
  2. Number and type of adverse events
  3. Changes in vital signs and weight
  4. Clinically significant changes in ECG (reported as AE)
  5. Change of Simpson-Angus Scale (SAS) score
  6. Change of Barnes Akathisia Rating Scale (BARS) score


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254787


Locations
Germany
Research Site
Berlin, Germany
Research Site
Cologne, Germany
Research Site
Essen, Germany
Research Site
Hamburg, Germany
Research Site
Jena, Germany
Research Site
Werneck, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Germany Medical Director AstraZeneca

ClinicalTrials.gov Identifier: NCT00254787     History of Changes
Other Study ID Numbers: D1441L00032
RACE
EudraCT-No. 2004-005122-45
First Posted: November 17, 2005    Key Record Dates
Last Update Posted: June 11, 2009
Last Verified: June 2009

Keywords provided by AstraZeneca:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs