Rapid Versus Conventional Titration of Quetiapine in Schizophrenia/Schizoaffective Disorder

Phase 3TerminatedNCT00457899

AstraZeneca234 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

234

Conditions

Schizophrenia Schizoaffective Disorders Psychotic Disorders

Interventions

Quetiapine IR (Immediate Release)DRUG

oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 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.

Locations (12)

Research Site

Brentwood, Essex, United Kingdom

Research Site

Harrow, Middlesex, United Kingdom

Research Site

Surbiton, Surrey, United Kingdom

Research Site

Outcomes

Primary Outcomes

The primary outcome variable of this study is change from baseline in total PANSS score

Time frame: at Day 7

Secondary Outcomes

Change from baseline in total PANSS scores

Time frame: on day 5 and 14

change from baseline in CGI-S and absolute CGI-I

Time frame: on days 5, 7 and 14

frequency and severity of adverse events; change in vital signs.

Time frame: assessed at each visit

change from baseline in subscale PANSS and PANSS-EC scores

Time frame: on days 5, 7 and 14

Data from ClinicalTrials.gov

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