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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00254787
First received: November 15, 2005
Last updated: June 9, 2009
Last verified: June 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
Study Completion Date: January 2006
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00254787     History of Changes
Other Study ID Numbers: D1441L00032, RACE, EudraCT-No. 2004-005122-45
Study First Received: November 15, 2005
Last Updated: June 9, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 29, 2014