Dose Finding of Quetiapine Fumarate 200mg vs 400mg in First Episode Psychosis

Phase 3

Completed

• Conditions: Psychosis

• Registration Number: NCT00449397
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Study First Submitted: 2007-03-19
• Study First Submitted QC: 2007-03-19
• Study First Posted: 2007-03-20
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-25
• Last Update Posted: 2011-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients experiencing their first psychotic episode
• Male or Female
• Aged 15-25

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Exclusion Criteria

• Previous treatment with antipsychotic medication (longer than 1 week)
• History of a clinically significant physical illness
• Organic disorder presenting with psychotic symptoms

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale

Secondary Outcome Measures

Name	Time	Method
SWN, UKU, illicit substance use, laboratory measures, altered drop-out rates

Trial Locations

Locations (1)

Research Sites; 🇦🇺 Melbourne, Australia