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Fast Titration in the Treatment of Schizophrenia, Taiwan
This study has been completed.
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00304473
  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 III

MedlinePlus related topics: Schizophrenia
Drug Information available for: Quetiapine Quetiapine fumarate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title: Fast Titration of Quetiapine Versus Conventional Titration in the Treatment of Schizophrenia/Schizoaffective Disorder: a Randomised, Parallel Group Open Trial

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304473

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

Study ID Numbers: D1449C00001
Study First Received: March 17, 2006
Last Updated: December 19, 2008
ClinicalTrials.gov Identifier: NCT00304473  
Health Authority: Taiwan: Department of Health

Keywords provided by AstraZeneca:
Schizophrenia

Study placed in the following topic categories:
Schizophrenia
Quetiapine
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
 Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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