Rapid Versus Conventional Titration of Quetiapine in Schizophrenia/Schizoaffective Disorder

Phase 3

Terminated

• Conditions: Psychotic Disorders; Schizophrenia; Schizoaffective Disorders

• Registration Number: NCT00457899
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to determine whether increasing the amount (dose) of quetiapine IR (immediate release formulation) more rapidly than conventional dose increases, improves the control of symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) - a psychiatric assessment scale that measures both positive and negative symptoms - in patients with acute schizophrenia or schizoaffective disorder.

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 First Submitted: 2007-04-05
• Study First Submitted QC: 2007-04-05
• Study First Posted: 2007-04-09
• Study Start: 2007-07
• Study Completion: 2007-09
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-26
• Last Update Posted: 2007-11-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

• Men and women, aged 18 to 65 years, who require treatment for an acute episode of schizophrenia/schizoaffective disorder as judged by their doctor

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Exclusion Criteria

• Significant and unstable conditions of hear, circulation, blood, liver, kidney; malignancies (cancer); diabetes (mellitus); history of fits or fainting. Resistance to antipsychotic medication. Current alcohol/drug abuse. Pregnant/breast feeding women.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome variable of this study is change from baseline in total PANSS score	at Day 7

Secondary Outcome Measures

Name	Time	Method
frequency and severity of adverse events; change in vital signs.	assessed at each visit
Change from baseline in total PANSS scores	on day 5 and 14
change from baseline in subscale PANSS and PANSS-EC scores	on days 5, 7 and 14
change from baseline in CGI-S and absolute CGI-I	on days 5, 7 and 14

Trial Locations

Locations (1)

Research Site; 🇬🇧 Warrington, United Kingdom