Dose finding of Quetiapine fumarate 200mg vs 400mg in First Episode Psychosis
Study identifier:AU-SEA-0003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A naturalistic, prospective, single centre, double blinded, fixed dose, randomised, four week comparison study investigating efficacy, tolerability and safety of 200 mg per day versus 400 mg per day quetiapine fumarate in 200 drug naïve first episode psychosis patients aged 15 to 25 years.
Medical condition
Psychosis
Phase
Phase 3
Healthy volunteers
No
Study drug
Quetiapine Fumarate
Sex
All
Actual Enrollment
150
Study type
Interventional
Age
15 Years - 25 Years
Date
Study Start Date: 01 Jul 2003
Primary Completion Date: 01 Jan 2006
Study Completion Date: 01 Jan 2006
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2011 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
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Contacts
Investigators
Principal Investigator
Gregor Berger
ORYGEN Research Centre/ ORYGEN Youth Health
