Back to resultsDose Finding of Quetiapine Fumarate 200mg vs 400mg in First Episode Psychosis
Primary Purpose
Psychosis
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Quetiapine Fumarate
Sponsored by
About this trial
This is an interventional treatment trial for Psychosis focused on measuring First Episode Psychosis
Eligibility Criteria
Inclusion Criteria:
- Patients experiencing their first psychotic episode
- Male or Female
- Aged 15-25
Exclusion Criteria:
- Previous treatment with antipsychotic medication (longer than 1 week)
- History of a clinically significant physical illness
- Organic disorder presenting with psychotic symptoms
Sites / Locations
- Research Sites
Outcomes
Primary Outcome Measures
Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale
Secondary Outcome Measures
SWN, UKU, illicit substance use, laboratory measures, altered drop-out rates
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00449397
Brief Title
Dose Finding of Quetiapine Fumarate 200mg vs 400mg in First Episode Psychosis
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is determine the minimal effective dose and the impact on:
treatment outcomes at 4, 12 and/or 48 weeks the treatment has required to treat patients experiencing the first psychotic episode
the final maintenance doses
the use of other medications
the amount of changes to other antipsychotic medication
the number of hospitalization days
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
First Episode Psychosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Quetiapine Fumarate
Primary Outcome Measure Information:
Title
Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale
Secondary Outcome Measure Information:
Title
SWN, UKU, illicit substance use, laboratory measures, altered drop-out rates
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients experiencing their first psychotic episode
Male or Female
Aged 15-25
Exclusion Criteria:
Previous treatment with antipsychotic medication (longer than 1 week)
History of a clinically significant physical illness
Organic disorder presenting with psychotic symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregor Berger, MD
Organizational Affiliation
ORYGEN Research Centre/ ORYGEN Youth Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Sites
City
Melbourne
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
19324499
Citation
Hides L, Cotton SM, Berger G, Gleeson J, O'Donnell C, Proffitt T, McGorry PD, Lubman DI. The reliability and validity of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in first-episode psychosis. Addict Behav. 2009 Oct;34(10):821-5. doi: 10.1016/j.addbeh.2009.03.001. Epub 2009 Mar 6.
Results Reference
derived
PubMed Identifier
19036233
Citation
Berger GE, Proffitt TM, McConchie M, Kerr M, Markulev C, Yuen HP, O'Donnell C, Lubman D, Polari A, Wood S, Amminger PG, McGorry PD. Dosing quetiapine in drug-naive first-episode psychosis: a controlled, double-blind, randomized, single-center study investigating efficacy, tolerability, and safety of 200 mg/day vs. 400 mg/day of quetiapine fumarate in 141 patients aged 15 to 25 years. J Clin Psychiatry. 2008 Nov;69(11):1702-14. Epub 2008 Nov 18.
Results Reference
derived
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Dose Finding of Quetiapine Fumarate 200mg vs 400mg in First Episode Psychosis
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