Fast Titration Of Quetiapine Versus Currently Approved Titration

Phase 3

Completed

• Conditions: Psychotic Disorders

• Registration Number: NCT00254813
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of a more rapid dose titration in acute schizophrenic patients compared to the conventional titration.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study Completion: 2005-09
• Study First Submitted: 2005-11-15
• Study First Submitted QC: 2005-11-15
• Study First Posted: 2005-11-17
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-25
• Last Update Posted: 2011-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Signed informed consent, male or female between 18 and 60 years old, having acute exacerbation of their schizophrenia or schizoaffective disorder requiring admission to hospital. Should stay in hospital for at least 7 days.

Exclusion Criteria

• Patients treated with Risperdal consta or Clozapine last 28 days, pregnancy or breast-feeding, patients known to be intolerant or unresponsive to quetiapine, known arrhythmia, other serious medical conditions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients with moderate and severe adverse events

Secondary Outcome Measures

Name	Time	Method
Mean daily level of somnolence and orthostatic dizziness as rated on AE intensity scale

Trial Locations

Locations (1)

Research Site; 🇳🇴 Ålesund, Norway