Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients (ESPRIT)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00882518
First received: April 14, 2009
Last updated: April 16, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) Drug: Chlorpromazine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Chlorpromazine
Formic acid
Chlorpromazine hydrochloride
Quetiapine
Quetiapine fumarate
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 388 |
| Study Start Date: | April 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1-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)
|
Drug: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
200 mg or 300 mg, oral, single dose
Other Name: Seroquel_XR (Quetiapine Fumarate XR)
|
|
Active Comparator: 2-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)
|
Drug: Chlorpromazine
50 mg, oral, double dose
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882518
Locations
| China, Changsha | |
| Research Site | |
| Hunan, Changsha, China | |
| China, Guangdong | |
| Research Site | |
| Guangzhou, Guangdong, China | |
| China, Hebei | |
| Research Site | |
| Baoding, Hebei, China | |
| China, Heilongjiang | |
| Research Site | |
| Ha Er Bin, Heilongjiang, China | |
| China, Hubei | |
| Research Site | |
| Wuhan, Hubei, China | |
| China, Hunan | |
| Research Site | |
| Changsha, Hunan, China | |
| China, Jiangsu | |
| Research Site | |
| Nanjing, Jiangsu, China | |
| China, Shanxi | |
| Research Site | |
| Xi'an, Shanxi, China | |
| China, Yunnan | |
| Research Site | |
| Kunming, Yunnan, China | |
| China | |
| Research Site | |
| Beijing, China | |
| Research Site | |
| Shanghai, China | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Niufan Gu | Shanghai Mental Health Center |
| Study Director: | Michael Castiglione | AstraZeneca |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00882518 History of Changes |
| Other Study ID Numbers: | D1444C00008 |
| Study First Received: | April 14, 2009 |
| Results First Received: | March 7, 2011 |
| Last Updated: | April 16, 2012 |
| Health Authority: | United States: Institutional Review Board China: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) qualified PANSS assessment |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Chlorpromazine Quetiapine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Gastrointestinal Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013