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

Phase 3

Terminated

• Conditions: Psychotic Disorders; Schizophrenia; Bipolar Disorder

• Registration Number: NCT00486798
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-06-14
• Study First Submitted QC: 2007-06-14
• Study First Posted: 2007-06-15
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2009-04
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of Positive and Negative Syndrome Scale-Excitatory Subscale (PANSS-EC) at day 5 compared with baseline at day 1

Secondary Outcome Measures

Name	Time	Method
Assessment of PANSS-EC at Day 3 and 8. Clinical Global Impression (CGI) at baseline and at Day 5 and 8. FAST (For Acute Seroquel Therapy) rating scale at baseline and at Day 5 and 8. The sleeping pattern (8days). Withdrawals/treatment failures. AE

Trial Locations

Locations (1)

Research Site; 🇸🇪 Vaxjo, Sweden