Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients (ESPRIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00882518
First received: April 14, 2009
Last updated: April 16, 2012
Last verified: April 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014