Clinical trial NCT01634542: An Non-Interventional Study of Patients With Persistent Symptoms of Schizophrenia
Official title: A Non-Interventional Prospective Cohort Study of Patients With Persistent Symptoms of Schizophrenia to Describe The Course and Burden of Illness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-07-06
Enrollment: 1433
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with persistent symptoms of schizophrenia

Brief summary: This multicenter, prospective, non-interventional study will evaluate the prevalence and characteristics of patients with persistent symptoms of schizophrenia and the course of their illness over 24 months.


Eligibility criteria: Inclusion Criteria:

Patients:

* Adult patients, \>/= 18 years of age
* Diagnosis of schizophrenia according to Diagnostic and Statistical Manual for Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) or International Classification of Diseases, 10th revision (ICD-10)

Caregivers:

* Age \>/= 18 years
* Family member or friend of the patient, who spends at least 4 hours a week with the patient

Exclusion Criteria:

* Acute psychotic exacerbation in the 3 months prior to the baseline observation (e.g. hospitalization or increased psychiatric care in order to prevent hospitalization)
* Enrolled in an interventional study at the baseline observation

Primary outcomes:
measure: Course of illness: Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores
timeFrame: from baseline to Month 24
Secondary outcomes:
measure: Frequency/characteristics (PANSS) of patients with diagnosis of schizophrenia of >/= 12 months duration before baseline
timeFrame: at screening (approximately 18 months)
measure: Duration/severity of symptoms of schizophrenia according to Personal Social Performance Scale (PSP) / Health Related Quality of Life (HRQoL) questionnaire
timeFrame: 24 months
measure: Medical resource utilization/costs
timeFrame: 24 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Caba
country: Argentina
city: La Plata
country: Argentina
city: Goiania
country: Brazil
state: GO
city: Curitiba
country: Brazil
state: PR
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Medicine Hat
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Chatam
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Québec
country: Canada
state: Quebec
city: Verdun
country: Canada
state: Quebec
city: Aix En Provence
country: France
city: Chaumont
country: France
city: Colmar
country: France
city: Corbeil Essonnes
country: France
city: Issy Les Moulineaux
country: France
city: Lille
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Montberon
country: France
city: Montebeliard
country: France
city: Montpellier
country: France
city: Nantes
country: France
city: Nice
country: France
city: Nice
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Poitiers
country: France
city: Rennes
country: France
city: Rouffach
country: France
city: St Cyr Au Mont D Or
country: France
city: Tassin La Demi Lune
country: France
city: Toulouse
country: France
city: Verdun
country: France
city: Aachen
country: Germany
city: Aachen
country: Germany
city: Alzey
country: Germany
city: Augsburg
country: Germany
city: Bad Zwischenahn
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Dortmund
country: Germany
city: Dresden
country: Germany
city: Düsseldorf
country: Germany
city: Ellwangen
country: Germany
city: Essen
country: Germany
city: Essen
country: Germany
city: Gruenstadt
country: Germany
city: Halle/Saale
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Homburg/Saar
country: Germany
city: Jena
country: Germany
city: Koeln-Pulheim
country: Germany
city: Köln
country: Germany
city: Leipzig
country: Germany
city: Leipzig
country: Germany
city: Magdeburg
country: Germany
city: Mainz
country: Germany
city: Mannheim
country: Germany
city: Marburg
country: Germany
city: Mittweida
country: Germany
city: Oranienburg
country: Germany
city: Regensburg
country: Germany
city: Rostock
country: Germany
city: Siegen
country: Germany
city: Weinsberg
country: Germany
city: Westerstede
country: Germany
city: Catanzaro
country: Italy
state: Calabria
city: Bologna
country: Italy
state: Emilia-Romagna
city: Trieste
country: Italy
state: Friuli-Venezia Giulia
city: Udine
country: Italy
state: Friuli-Venezia Giulia
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Genova
country: Italy
state: Liguria
city: Cassina Nuova di Bollate
country: Italy
state: Lombardia
city: Gardone V.T.
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Campobasso
country: Italy
state: Molise
city: Bra
country: Italy
state: Piemonte
city: Novara
country: Italy
state: Piemonte
city: Bari
country: Italy
state: Puglia
city: Cagliari
country: Italy
state: Sardegna
city: Sassari
country: Italy
state: Sardegna
city: Catania
country: Italy
state: Sicilia
city: Messina
country: Italy
state: Sicilia
city: Palermo
country: Italy
state: Sicilia
city: Firenze
country: Italy
state: Toscana
city: Perugia
country: Italy
state: Umbria
city: Conegliano
country: Italy
state: Veneto
city: Padova
country: Italy
state: Veneto
city: Alcoy
country: Spain
state: Alicante
city: Langreo
country: Spain
state: Asturias
city: Terrassa
country: Spain
state: Barcelona
city: Santander
country: Spain
state: Cantabria
city: Torrelavega
country: Spain
state: Cantabria
city: Manacor
country: Spain
state: Islas Baleares
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Coruña
country: Spain
state: La Coruña
city: Pamploma
country: Spain
state: Navarra
city: Pamplona
country: Spain
state: Navarra
city: Vigo
country: Spain
state: Pontevedra
city: Reus
country: Spain
state: Tarragona
city: Bilbao
country: Spain
state: Vizcaya
city: Bilbao
country: Spain
state: Vizcaya
city: Vitoria
country: Spain
state: Vizcaya
city: Almeria
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Burgos
country: Spain
city: Granada
country: Spain
city: Malaga
country: Spain
city: Palencia
country: Spain
city: Soria
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Belfast
country: United Kingdom
city: Bristol
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Cheshire
country: United Kingdom
city: Cornwall
country: United Kingdom
city: Coventry
country: United Kingdom
city: Essex
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Hemel Hempstead
country: United Kingdom
city: Lincolnshire
country: United Kingdom
city: Norfolk
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Stoke-on-Trent
country: United Kingdom
city: Walsall
country: United Kingdom
city: Wolverhampton
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Domenech C, Pastore A, Altamura AC, Bernasconi C, Corral R, Elkis H, Evans J, Malla A, Margari F, Krebs MO, Nordstroem AL, Zink M, Haro JM. Correlation of Health-Related Quality of Life in Clinically Stable Outpatients with Schizophrenia. Neuropsychiatr Dis Treat. 2019 Dec 20;15:3475-3486. doi: 10.2147/NDT.S218578. eCollection 2019.
citation: Franklin M, Mukuria C, Mulhern B, Tran I, Brazier J, Watson S. Measuring the Burden of Schizophrenia Using Clinician and Patient-Reported Measures: An Exploratory Analysis of Construct Validity. Patient. 2019 Aug;12(4):405-417. doi: 10.1007/s40271-019-00358-x.
citation: Domenech C, Bernasconi C, Moneta MV, Nordstroem AL, Cristobal-Narvaez P, Vorstenbosch E, Cobo J, Ochoa S, Haro JM. Health-related quality of life associated with different symptoms in women and in men who suffer from schizophrenia. Arch Womens Ment Health. 2019 Jun;22(3):357-365. doi: 10.1007/s00737-018-0896-0. Epub 2018 Aug 7.