FAST-A Study to Evaluate the Efficacy and Safety of Quetiapin IR in Patients With Acute Psychosis

AstraZeneca

Status and phase: Terminated; Phase 3

Conditions: Psychotic Disorders; Schizophrenia; Bipolar Disorder

Treatments: Procedure: Self Assessment Form; Procedure: Blood and urine samples; Procedure: Sleeping pattern; Procedure: Rating Scales; Drug: Quetiapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00486798

EUDRAC No. 2006-006426-26

D1443L00009

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of quetiapine IR, following rapid titration versus conventional titration in patients with acute psychosis

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• provision of written informed consent
• male or female, aged 18-65 years
• requirement of hospitalization and in need for antipsychotic treatment for an acute psychotic episode
• able to swallow tablets from Day 1

Exclusion criteria

• In-patients who are anticipated to be discharged before evaluation of the primary outcome variable at Day 5
• patients with known relevant clinical disease
• history of syncope, or orthostatic hypotension
• patients with known neutropenia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)