Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in Acute Schizophrenic Patients

AstraZeneca30 enrolled

Overview

The purpose of the study is to compare the safety and tolerability of IR (Immediate-Release) quetiapine in a rapid escalation scheme with to the current approved label titration.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Schizophrenia

Interventions

IR (Immediate-Release) quetiapine fumarate (drug)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women age ≥18 to ≤65 years with acute schizophrenia * Provision of written informed consent prior to enrolment Exclusion Criteria: * Meeting the criteria for any other (than schizophrenia) psychotic disorder not in full remission, concomitant organic mental disorder or mental retardation * Patients with substance dependence * Female patients who are pregnant, lactating or at risk of pregnancy

Locations (6)

Research Site

Berlin, Germany

Research Site

Cologne, Germany

Research Site

Essen, Germany

Research Site

Hamburg, Germany

Research Site

Jena, Germany

Outcomes

Primary Outcomes

Proportion of patients who discontinue the study treatment due to adverse events (AEs) during the first week (day 1 to day 7) of treatment

Secondary Outcomes

Safety and Tolerability

Number and type of adverse events

Changes in vital signs and weight

Clinically significant changes in ECG (reported as AE)

Change of Simpson-Angus Scale (SAS) score

Change of Barnes Akathisia Rating Scale (BARS) score

Data from ClinicalTrials.gov

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