Clinical trial NCT00543088: Effectiveness of Anti-Psychotic in GPs Setting
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Bipolar Disorder
Keywords: Schizophrenia
Bipolar Disorder
manic episode
atypical antipsychotic
Schizophrenia or Bipolar Disorder (currently in a manic episode)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-10-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief 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


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: 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 outcomes:
measure: The clinical efficacy & tolerability of atypical antipsychotics as assessed by the Clinical Global Impression(CGI) & Patient Global Impression of Change(PGIC)scores.
measure: The wellbeing of the patients taking atypical antipsychotics as assessed by the Sheehan Disability Scale(SDS)
Other outcomes:
Locations:
city: Baudour
country: Belgium
facility: Research Site
city: Beyne-Heysay
country: Belgium
facility: Research Site
city: Bomal-sur-Ourthe
country: Belgium
facility: Research Site
city: Bredene
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Esen
country: Belgium
facility: Research Site
city: Evere
country: Belgium
facility: Research Site
city: Gingelom
country: Belgium
facility: Research Site
city: Gouy-Lez-Pieton
country: Belgium
facility: Research Site
city: Grace-Hollogne
country: Belgium
facility: Research Site
city: Gullegem
country: Belgium
facility: Research Site
city: Harelbeke
country: Belgium
facility: Research Site
city: Harre
country: Belgium
facility: Research Site
city: Hotton
country: Belgium
facility: Research Site
city: Houtvenne
country: Belgium
facility: Research Site
city: Incourt
country: Belgium
facility: Research Site
city: Ixelles
country: Belgium
facility: Research Site
city: Jalhay
country: Belgium
facility: Research Site
city: Jette
country: Belgium
facility: Research Site
city: Keumiee
country: Belgium
facility: Research Site
city: Lembeke
country: Belgium
facility: Research Site
city: Limbourg
country: Belgium
facility: Research Site
city: Li�ege
country: Belgium
facility: Research Site
city: Longueville
country: Belgium
facility: Research Site
city: Lovendegem
country: Belgium
facility: Research Site
city: Malmedy
country: Belgium
facility: Research Site
city: Mechelen
country: Belgium
facility: Research Site
city: Monceau sur Sambre
country: Belgium
facility: Research Site
city: Montignies sur sambre
country: Belgium
facility: Research Site
city: Moorseled
country: Belgium
facility: Research Site
city: Moorsel
country: Belgium
facility: Research Site
city: Mouscron
country: Belgium
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Oostrozebeke
country: Belgium
facility: Research Site
city: Ostende
country: Belgium
facility: Research Site
city: Oudenaarde
country: Belgium
facility: Research Site
city: Poperinge
country: Belgium
facility: Research Site
city: Ransart
country: Belgium
facility: Research Site
city: Roux
country: Belgium
facility: Research Site
city: Ruisbroek
country: Belgium
facility: Research Site
city: Schaerbeek
country: Belgium
facility: Research Site
city: Spa
country: Belgium
facility: Research Site
city: Staden
country: Belgium
facility: Research Site
city: Theux
country: Belgium
facility: Research Site
city: Tilleur
country: Belgium
facility: Research Site
city: Torhout
country: Belgium
facility: Research Site
city: Tubize
country: Belgium
facility: Research Site
city: Verviers
country: Belgium
facility: Research Site
city: Veurne
country: Belgium
facility: Research Site
city: Wachtebeke
country: Belgium
facility: Research Site
city: Willebroek
country: Belgium
facility: Research Site
city: Wilrijk
country: Belgium
facility: Research Site
city: Woluwe-St-Lambert
country: Belgium
facility: Research Site
city: Zeebrugge
country: Belgium
facility: Research Site
city: Zichem
country: Belgium
facility: Research Site
city: Zomergem
country: Belgium
facility: Research Site
city: Zonnebeke
country: Belgium
facility: Research Site
Study officials:
affiliation: ULg
name: Pitchot W Pr
role: PRINCIPAL_INVESTIGATOR
References: