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

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

Sponsors

Lead Sponsor: AstraZeneca

Source 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.

Overall Status Completed
Start Date 2009-04-01
Completion Date 2010-07-01
Primary Completion Date 2010-07-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Secondary Outcome
Measure Time Frame
Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42 Baseline and 6 weeks
Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42 Baseline and 6 weeks
Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42 Baseline and 6 weeks
Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42 Baseline and 6 weeks
Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42 Baseline and 6 weeks
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
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
Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42 Baseline and 6 weeks
Enrollment 388
Condition
Intervention

Intervention Type: Drug

Intervention Name: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)

Description: 200 mg or 300 mg, oral, single dose

Arm Group Label: 1-Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)

Other Name: Seroquel_XR (Quetiapine Fumarate XR)

Intervention Type: Drug

Intervention Name: Chlorpromazine

Description: 50 mg, oral, double dose

Arm Group Label: 2-Chlorpromazine

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Location
Facility:
Research Site | Hunan, Changsha, China
Research Site | Guangzhou, Guangdong, China
Research Site | Baoding, Hebei, China
Research Site | Ha Er Bin, Heilongjiang, China
Research Site | Wuhan, Hubei, China
Research Site | Changsha, Hunan, China
Research Site | Nanjing, Jiangsu, China
Research Site | Xi'an, Shanxi, China
Research Site | Kunming, Yunnan, China
Research Site | Beijing, China
Research Site | Shanghai, China
Location Countries

China

Verification Date

2012-04-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1-Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)

Type: Experimental

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)

Label: 2-Chlorpromazine

Type: Active Comparator

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)

Acronym ESPRIT
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

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