Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00428350

Purpose

The primary objective of the study is to evaluate the efficacy of quetiapine fumarate (Seroquel) with daily dose 600mg-750mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline in PANSS total score at Day 56 using the last observation carried forward (LOCF) method.

Condition	Intervention	Phase
Schizophrenia	Drug: Quetiapine Fumarate (Seroquel)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A 24-Week, Multi-Centre, Open-Label, Single-Arm, Phase IV Study of the Efficacy and Safety of Seroquel (Quetiapine Fumarate) With Daily Dose 600mg-750mg as Mono-Therapy in the Treatment of Acute Schizophrenic Patients

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:

Change from baseline in PANSS total score at Day 56 (LOCF)

Secondary Outcome Measures:

Change from baseline in PANSS positive scale score at Day 56 (LOCF)
Change from baseline in PANSS negative scale score at Day 56 (LOCF)
Change from baseline in PANSS EC score at day 56 ,
Change from baseline in MADRS total score at Day 56. etc

Estimated Enrollment:	120
Study Start Date:	December 2006
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provision of written informed consent for study participation before initiation of any study related procedures, signed by the patient's legal guardian
Female and/or male, aged between 18 and 60 years (inclusive)
Is hospitalised in a psychiatric unit with an acute episode of schizophrenia defined by CCMD-3 criteria as one of the following: [20.1] paranoid schizophrenia, [20.2] hebephrenic schizophrenia, [20.3] catatonic schizophrenia, [20.5] undifferentiated schizophrenia

Exclusion Criteria:

CCMD-3 diagnosis of mental retardation
Psychosis judged to be the direct physiological effect of an abused medication or substance

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428350

Locations

China
Research Site
Beijing, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Heilongjiang
Research Site
Harbin, Heilongjiang, China
China, Hubei
Research SIte
Wuhan, Hubei, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
China, Shandong
Research Site
Jinan, Shandong, China
China, Yunnan
Research Site
Kunming, Yunnan, China
China, Zhejiang
Research Site
Huzhou, Zhejiang, China
Research Site
Hangzhou, Zhejiang, China

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Jon Zhu, MD	AstraZeneca
Principal Investigator:	Gang Wang, MD	Beijing An Ding hospital

More Information

No publications provided

Study ID Numbers:	D1443L00004, SOLO
Study First Received:	January 29, 2007
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00428350 History of Changes
Health Authority:	China: State Food and Drug Administration

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 February 08, 2010