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

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 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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: Formic acid Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The Change in Positive and Negative Syndrome Scale(PANSS)Total Score [ Time Frame: From baseline to Day 57 ] [ Designated as safety issue: No ]
PANSS, a 30-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme), total score is 30 - 210.

Description of the reporting Groups: Evaluate the efficacy of Quetiapine XR with daily dose 400 mg - 800 mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline to Day 57 in total score of PANSS using the last observation carried forward (LOCF) method

Secondary Outcome Measures:

Positive and Negative Syndrome Scale (PANSS) Positive Score [ Time Frame: From baseline to Day 57 ] [ Designated as safety issue: No ]
To evaluate the change of positive symptoms from baseline to Day 57 in PANSS positive score, a 7-item scale where eash symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)
Positive and Negative Syndrome Scale (PANSS) Negative Score [ Time Frame: From baseline to Day 57 ] [ Designated as safety issue: No ]
To evaluate the change of negative symptoms from baseline to Day 57 in PANSS negative score, a 7-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)
Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score [ Time Frame: From baseline to Day 57 ] [ Designated as safety issue: No ]
To evaluate the change of general psychopathology symptoms from baseline to Day 57 in PANSS general score, a 16-item scale where each symptom is rated on a severity scale ranging from 1 (absent) to - 7 (extreme)
Clinical Global Impression (CGI) Score [ Time Frame: From baseline to Day 57 ] [ Designated as safety issue: No ]
The Clinical Global Impression - Severity (CGI-S) and - illness (CGI-I) is used in this study. The CGI-S is scored to rate the patient's current clinical state. The CGI-I is scored to rate the patient's change from baseline CGI. Each CGI item is scored on a scale from 1 to 7 (CGI-S: 1 = Normal, not ill, 7= Among the most extremely ill patients/ CGI-I: 1= very much improved, 7= very much worse). CGI-I scores greater than 4 indicate worsening, while scores less than 4 indicate improvement
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: From baseline to Day 57 ] [ Designated as safety issue: No ]
To treat depressive symptoms in acute schizophrenic patients by evaluation of the change from baseline to day 67 in MADRS total score, a 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0-6 scale, higher MADRS scores indicate higher levels of depressive symptoms.
Global Assessment of Functioning (GAF) Score [ Time Frame: From baseline to Day 57 ] [ Designated as safety issue: No ]
To improve functional capability in acute schizophrenic patients by evaluation of the change from baseline to Day 57 in GAF scale score, a single-item rating scale for evaluating the overall functioning on a continuum from psychologic or psychiatric sickness to health.

Enrollment:	96
Study Start Date:	November 2008
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

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

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

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

YounHoon Kim

Inje University

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00779506 History of Changes
Other Study ID Numbers:	D1443L00062
Study First Received:	October 22, 2008
Results First Received:	May 20, 2010
Last Updated:	October 19, 2011
Health Authority:	Korea: Food and Drug Administration

Keywords provided by AstraZeneca:

Acute schizophrenia
PANSS

Additional relevant MeSH terms:

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 22, 2013

Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR) (QUENCH)