Fast Titration Of Quetiapine Versus Currently Approved Titration

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00254813
First received: November 15, 2005
Last updated: January 25, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to evaluate the safety and tolerability of a more rapid dose titration in acute schizophrenic patients compared to the conventional titration.


Condition Intervention Phase
Psychotic Disorders
Drug: Quetiapine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fast Titration Of Quetiapine Versus Currently Approved Titration: A Randomised, Multicentre, Parallel Group Open Trial In Schizophrenia And Schizoaffective Disorder

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Proportion of patients with moderate and severe adverse events

Secondary Outcome Measures:
  • Mean daily level of somnolence and orthostatic dizziness as rated on AE intensity scale

Estimated Enrollment: 150
Study Start Date: October 2004
Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent, male or female between 18 and 60 years old, having acute exacerbation of their schizophrenia or schizoaffective disorder requiring admission to hospital. Should stay in hospital for at least 7 days.

Exclusion Criteria:

  • Patients treated with Risperdal consta or Clozapine last 28 days, pregnancy or breast-feeding, patients known to be intolerant or unresponsive to quetiapine, known arrhythmia, other serious medical conditions.
  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: NCT00254813

Locations
Norway
Research Site
Arendal, Norway
Research Site
Klepp Stasjon, Norway
Research Site
Kristiansand, Norway
Research Site
Nesttun, Norway
Research Site
Oslo, Norway
Research Site
Ottestad, Norway
Research Site
Ålesund, Norway
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Norway Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00254813     History of Changes
Other Study ID Numbers: D1449L00003
Study First Received: November 15, 2005
Last Updated: January 25, 2011
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by AstraZeneca:
Schizophrenia
Schizoaffective disorder

Additional relevant MeSH terms:
Disease
Mental Disorders
Psychotic Disorders
Pathologic Processes
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 21, 2014