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Fast Titration in the Treatment of Schizophrenia, Taiwan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00304473
First Posted: March 20, 2006
Last Update Posted: March 25, 2009
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

Assess the efficacy of a fast titration of quetiapine to the current titration approved by the regulatory authorities.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Condition Intervention Phase
Schizophrenia Drug: Quetiapine fumarate 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 Conventional Titration in the Treatment of Schizophrenia/Schizoaffective Disorder: a Randomised, Parallel Group Open Trial

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Compare the safety and tolerability of a fast titration of quetiapine to the current titration approved by the regulatory authorities.

Secondary Outcome Measures:
  • Assess the efficacy of a fast titration of quetiapine to the current titration approved by the regulatory authorities.

Estimated Enrollment: 40
Study Start Date: August 2004
Study Completion Date: April 2006
  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 and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent, at least 18 years old, inpatients with relapse Schizophrenia all subtypes, and with a CGI (Clinical Global Impression) score >=4.

Exclusion Criteria:

  • Pregnancy or breast-feeding, patients treated with Clozapine within 28 days of randomization, patients with a known arrhythmia, any psychotic disorders not defined in the inclusion criteria.
  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): NCT00304473


Locations
Taiwan
Research Site
Taoyuan, Taiwan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Taiwan Medical Director, MD AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00304473     History of Changes
Other Study ID Numbers: D1449C00001
First Submitted: March 17, 2006
First Posted: March 20, 2006
Last Update Posted: March 25, 2009
Last Verified: March 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