Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR) - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00779506

Purpose

This is an 8-week, multi-centre, Open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients. The eligible patient will be assigned to study treatment with Quetiapine XR on Day 1.

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 XR	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A 8-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR) With Daily Dose 400mg-800mg 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 in PANSS total score [ Time Frame: From baseline to Day 57 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in PANSS positive scale score [ Time Frame: From baseline to Day 57 ] [ Designated as safety issue: No ]
Change in PANSS negative scale score [ Time Frame: From baseline to Day 57 ] [ Designated as safety issue: No ]
Change in PANSS general psychopathology score [ Time Frame: From baseline to Day 57 ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2008
Study Completion Date:	July 2009

Arms	Assigned Interventions
Quetiapine Fumarate XR: Experimental Seroquel XR 400-800mg	Drug: Quetiapine Fumarate XR oral, once daily, flexible dose

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
PANSS total score of at least 70 at enrolment and at assignment Day 1
CGI Severity of Illness score of at least 4 (moderately ill) at enrolment and at assignment Day 1 and with worsening of the patient's condition during the 3 weeks

Exclusion Criteria:

Known intolerance or lack of response to quetiapine fumarate
Administration of a depot antipsychotic injection within one dosing interval (for the depot) before assignment
Substance or alcohol dependence at enrolment
Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779506

Locations

Korea, Republic of
Research site
Pusan, Korea, Republic of
Research site
Seoul, Korea, Republic of
Research site
Incheon, Korea, Republic of
Korea, Republic of, Gyeonggi-do
Research site
Ansan, Gyeonggi-do, Korea, Republic of
Research site
Gwangju, Gyeonggi-do, Korea, Republic of
Korea, Republic of, Gyeongsangnam-do
Research site
Bugok, Gyeongsangnam-do, Korea, Republic of
Research site
Masan, Gyeongsangnam-do, Korea, Republic of

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

YounHoon Kim

Inje University Pusan Paik Hospital

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Bahn, JoonWoo, MD )
Study ID Numbers:	D1443L00062
Study First Received:	October 22, 2008
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00779506 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by AstraZeneca:

Acute schizophrenia
PANSS

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