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Fast Titration Of Quetiapine Versus Currently Approved Titration

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ClinicalTrials.gov Identifier: NCT00254813
Recruitment Status : Completed
First Posted : November 17, 2005
Last Update Posted : January 26, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Psychotic Disorders Drug: Quetiapine Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2004
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

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): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00254813     History of Changes
Other Study ID Numbers: D1449L00003
First Posted: November 17, 2005    Key Record Dates
Last Update Posted: January 26, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Schizophrenia
Schizoaffective disorder

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