Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR); Drug: Chlorpromazine

• Registration Number: NCT00882518
• Lead Sponsor: AstraZeneca

Brief Summary

The primary objective of this study is to evaluate the efficacy of quetiapine fumarate extended-release (XR) used as mono-therapy, administered once daily, in the treatment of schizophrenic patient with acute episode.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-14
• Study First Submitted QC: 2009-04-15
• Study First Posted: 2009-04-16
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-03-07
• Status Verified: 2012-04
• Results First Submitted QC: 2012-04-16
• Last Update Submitted: 2012-04-16
• Results First Posted: 2012-05-15
• Last Update Posted: 2012-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 388

Inclusion Criteria

• Schizophrenia diagnosis
• Provision of written informed consent before initiation of any study

Exclusion Criteria

• AIDS and hepatitis B
• History of seizure disorder
• Hospitalisation for schizophrenic more than 1 month immediately before enter into study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1-Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)	Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)	Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) extended-release (300 mg/1st day, 600 mg/2nd day, 400 or 600 or 800 mg/3-42 day)
2-Chlorpromazine	Chlorpromazine	Chlorpromazine (50 or 100 mg/1st day; 100-200 mg/2nd day; 150-300 mg/3rd day; 200-400 mg/4th day; 300 or 400 or 500 or 600 mg/5-42 days)

Primary Outcome Measures

Name	Time	Method
Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42	Baseline and 6 weeks	6 weeks minus baseline.PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. Total scores range 30-210 from better to worse.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42	Baseline and 6 weeks	6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme The PANSS positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42	Baseline and 6 weeks	6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme The PANSS negative subscale score is the sum of the 7 item scores (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking), ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42	Baseline and 6 weeks	The PANSS psychopathological subscale score is the sum of 16 item scores(somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, active social avoidance), ranges from 16 to 112. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42	Baseline and 6 weeks	6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).; 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme
Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42	Baseline and 6 weeks	6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).; 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme
Number of Patients Achieving a Reduction of at Least 30% From Baseline PANSS Total Score at the End of Treatment at Day 42	Baseline and 6 weeks	6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).Total scores range 30-210 from better to worse.; 1 =Absent,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme.
Percentage of Patients With Clinical Global Impression (CGI) Global Improvement Rating Less Than or Equal to 3 at the End of Treatment at Day 42	Baseline and 6 weeks	6 weeks minus baseline. The number of patients with CGI Global Improvement (CGI-I) rating at least "minimally improved" at the end of treatment at Day 42 was counted, and then got the proportion among all the patients.CGI-I is scored to rate the patient's change from baseline CGI on a seven-point scale (1="Very much improved", 7="Very much worse".)
Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42	Baseline and 6 weeks	6 weeks minus baseline The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale rating the severity of the patient's illness. The patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.

Trial Locations

Locations (1)

Research Site; 🇨🇳 Shanghai, China