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NCT00254813 Clinical Trial

Fast Titration Of Quetiapine Versus Currently Approved Titration

Psychotic Disorders Clinical Trial

Official title:
Fast Titration Of Quetiapine Versus Currently Approved Titration: A Randomised, Multicentre, Parallel Group Open Trial In Schizophrenia And Schizoaffective Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00254813
Other study ID # D1449L00003
Secondary ID
Status Completed
Phase Phase 3
First received November 15, 2005
Last updated January 25, 2011
Start date October 2004
Est. completion date September 2005

Study information
Verified date January 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Quetiapine

Locations
Country Name City State
Norway Research Site Ålesund
Norway Research Site Arendal
Norway Research Site Klepp Stasjon
Norway Research Site Kristiansand
Norway Research Site Nesttun
Norway Research Site Oslo
Norway Research Site Ottestad

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients with moderate and severe adverse events
Secondary Mean daily level of somnolence and orthostatic dizziness as rated on AE intensity scale
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