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Fast Titration Of Quetiapine Versus Currently Approved Titration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00254813
First Posted: November 17, 2005
Last Update Posted: January 26, 2011
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.
Information provided by:
AstraZeneca
  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
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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00254813     History of Changes
Other Study ID Numbers: D1449L00003
First Submitted: November 15, 2005
First Posted: November 17, 2005
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