Back to resultsEfficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients (ESPRIT)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
Chlorpromazine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Quetiapine Fumarate (SEROQUEL) Extended-Release (XR), qualified PANSS assessment
Eligibility Criteria
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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1-Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
2-Chlorpromazine
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42
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
Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42
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
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
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
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00882518
Brief Title
Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients
Acronym
ESPRIT
Official Title
A 6-Week, Multi-centre, Double-blind, Double-dummy, Chlorpromazine-Controlled Randomised Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate Extended-Release in the Treatment of Schizophrenic Patients With Acute Episode
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR), qualified PANSS assessment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
388 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1-Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
Arm Type
Experimental
Arm Description
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)
Arm Title
2-Chlorpromazine
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
Other Intervention Name(s)
Seroquel_XR (Quetiapine Fumarate XR)
Intervention Description
200 mg or 300 mg, oral, single dose
Intervention Type
Drug
Intervention Name(s)
Chlorpromazine
Intervention Description
50 mg, oral, double dose
Primary Outcome Measure Information:
Title
Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42
Description
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.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42
Description
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
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42
Description
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
Time Frame
Baseline and 6 weeks
Title
Number of Patients Achieving a Reduction of at Least 30% From Baseline PANSS Total Score at the End of Treatment at Day 42
Description
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.
Time Frame
Baseline and 6 weeks
Title
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
Description
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".)
Time Frame
Baseline and 6 weeks
Title
Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42
Description
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.
Time Frame
Baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niufan Gu
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Castiglione
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Hunan
State/Province
Changsha
Country
China
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Research Site
City
Baoding
State/Province
Hebei
Country
China
Facility Name
Research Site
City
Ha Er Bin
State/Province
Heilongjiang
Country
China
Facility Name
Research Site
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Research Site
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Research Site
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Research Site
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
Research Site
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
Research Site
City
Beijing
Country
China
Facility Name
Research Site
City
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients
We'll reach out to this number within 24 hrs