Effectiveness of Anti-Psychotic in GPs Setting

Schizophrenia Clinical Trial

— Serenity  

Official title:

SERENITY: Evaluating the Effectiveness of Atypical Antipsychotics in the Community - a Prospective, Multicentre, Observational Study to Evaluate the Impact on Quality of Life of GP-Bases Management of Antipsychotic Treatment in Belgium.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00543088
• Other study ID #: SRP-NB-SER-2006/1
• Status: Completed
• Phase: N/A
• First received: October 11, 2007
• Last updated: April 22, 2009
• Start date: January 2007
• Est. completion date: June 2008

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Not require for this study:
• Study type: Observational

Clinical Trial Summary

Evaluating the effectiveness of atypical antipsychotics in the community - a prospective, multicentre, observational study to evaluate the impact on Quality of Life of GP-based management of antipsychotic treatment in Belgium

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with Schizophrenia or Bipolar Disorder (currently in a manic episode)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder
• Schizophrenia

Locations

Country	Name	City	State
Belgium	Research Site	Baudour
Belgium	Research Site	Beyne-Heysay
Belgium	Research Site	Bomal-sur-Ourthe
Belgium	Research Site	Bredene
Belgium	Research Site	Bruxelles
Belgium	Research Site	Esen
Belgium	Research Site	Evere
Belgium	Research Site	Gingelom
Belgium	Research Site	Gouy-Lez-Pieton
Belgium	Research Site	Grace-Hollogne
Belgium	Research Site	Gullegem
Belgium	Research Site	Harelbeke
Belgium	Research Site	Harre
Belgium	Research Site	Hotton
Belgium	Research Site	Houtvenne
Belgium	Research Site	Incourt
Belgium	Research Site	Ixelles
Belgium	Research Site	Jalhay
Belgium	Research Site	Jette
Belgium	Research Site	Keumiee
Belgium	Research Site	Lembeke
Belgium	Research Site	Li?ege
Belgium	Research Site	Limbourg
Belgium	Research Site	Longueville
Belgium	Research Site	Lovendegem
Belgium	Research Site	Malmedy
Belgium	Research Site	Mechelen
Belgium	Research Site	Monceau sur Sambre
Belgium	Research Site	Montignies sur sambre
Belgium	Research Site	Moorsel
Belgium	Research Site	Moorseled
Belgium	Research Site	Mouscron
Belgium	Research Site	Namur
Belgium	Research Site	Oostrozebeke
Belgium	Research Site	Ostende
Belgium	Research Site	Oudenaarde
Belgium	Research Site	Poperinge
Belgium	Research Site	Ransart
Belgium	Research Site	Roux
Belgium	Research Site	Ruisbroek
Belgium	Research Site	Schaerbeek
Belgium	Research Site	Spa
Belgium	Research Site	Staden
Belgium	Research Site	Theux
Belgium	Research Site	Tilleur
Belgium	Research Site	Torhout
Belgium	Research Site	Tubize
Belgium	Research Site	Verviers
Belgium	Research Site	Veurne
Belgium	Research Site	Wachtebeke
Belgium	Research Site	Willebroek
Belgium	Research Site	Wilrijk
Belgium	Research Site	Woluwe-St-Lambert
Belgium	Research Site	Zeebrugge
Belgium	Research Site	Zichem
Belgium	Research Site	Zomergem
Belgium	Research Site	Zonnebeke

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate the patient's functioning, by measuring the Quality of Life. Quality of Life will be assessed by the Q-LES-Q-16 (PRO).
Secondary	The clinical efficacy & tolerability of atypical antipsychotics as assessed by the Clinical Global Impression(CGI) & Patient Global Impression of Change(PGIC)scores.
Secondary	The wellbeing of the patients taking atypical antipsychotics as assessed by the Sheehan Disability Scale(SDS)