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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: IR (Immediate-Release) quetiapine fumarate (drug)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00254787

RACE

EudraCT-No. 2004-005122-45

D1441L00032

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind