Fast Titration in the Treatment of Schizophrenia, Taiwan

This study has been completed.

First Received: March 17, 2006 Last Updated: March 24, 2009 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Quetiapine Quetiapine fumarate

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

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

Keywords provided by AstraZeneca:

Schizophrenia

Study placed in the following topic categories:

Schizophrenia
Quetiapine
Tranquilizing Agents
Mental Disorders
Psychotropic Drugs

Central Nervous System Depressants
Psychotic Disorders
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Quetiapine
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 24, 2009