Dose Finding of Quetiapine Fumarate 200mg vs 400mg in First Episode Psychosis
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.
1 other identifier
interventional
150
1 country
1
Brief Summary
The purpose of this study is determine the minimal effective dose and the impact on:
- 1.treatment outcomes at 4, 12 and/or 48 weeks the treatment has required to treat patients experiencing the first psychotic episode
- 2.the final maintenance doses
- 3.the use of other medications
- 4.the amount of changes to other antipsychotic medication
- 5.the number of hospitalization days
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2003
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 19, 2007
CompletedFirst Posted
Study publicly available on registry
March 20, 2007
CompletedJanuary 27, 2011
January 1, 2011
2.5 years
March 19, 2007
January 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale
Secondary Outcomes (1)
SWN, UKU, illicit substance use, laboratory measures, altered drop-out rates
Interventions
Eligibility Criteria
You may qualify if:
- Patients experiencing their first psychotic episode
- Male or Female
- Aged 15-25
You may not qualify if:
- Previous treatment with antipsychotic medication (longer than 1 week)
- History of a clinically significant physical illness
- Organic disorder presenting with psychotic symptoms
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Sites
Melbourne, Australia
Related Publications (2)
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.
PMID: 19324499DERIVEDBerger 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.
PMID: 19036233DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregor Berger, MD
ORYGEN Research Centre/ ORYGEN Youth Health
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 19, 2007
First Posted
March 20, 2007
Study Start
July 1, 2003
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
January 27, 2011
Record last verified: 2011-01