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Fast Titration in the Treatment of Schizophrenia, Taiwan

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00304473
First received: March 17, 2006
Last updated: March 24, 2009
Last verified: March 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00304473     History of Changes
Other Study ID Numbers: D1449C00001
Study First Received: March 17, 2006
Last Updated: March 24, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by AstraZeneca:
Schizophrenia

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013