Clinical trial NCT01959659: A Non-Interventional Study of Patients With Persistent Symptoms of Schizophrenia to Describe Medical Resource Utilization and Burden of Illness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 1431
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with persistent symptoms of schizophrenia despite receiving adequately dosed antipsychotic treatment and who have not had an acute exacerbation in the last 3 months

Brief summary: This non-interventional, cross-sectional survey and retrospective review will evaluate the medical resource utilization and burden of illness in patients who have persistent symptoms of schizophrenia despite receiving adequately dosed antipsychotic treatment and who have not had an acute exacerbation in the 3 months prior to enrolment. Medical records will be reviewed for a minimum of 3 months and up to 12 months prior to screening. Data collection at a single visit will include rating scales and questionnaires that reflect the clinical status and the quality of life of the patients and the economic impact of schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Patients who have a clinical diagnosis of schizophrenia as documented in their medical records
* Patients who, in the opinion of the investigator, have had on-going, persistent symptoms of schizophrenia for at least the last 3 months prior to enrolment
* Patients who, in the opinion of the investigator, have been prescribed adequate doses of antipsychotic treatment for at least the last 3 months
* Patient has adequate spoken local language

Exclusion Criteria:

* Acute exacerbation of schizophrenia within the last 3 months prior to enrolment
* Enrolment in an interventional study

Primary outcomes:
measure: Medical resource utilization (in-/out-patient hospital services, community-based day service, other health care contacts) of patients with persistent symptoms of schizophrenia
timeFrame: in the 3 to 12 months prior to screening
Secondary outcomes:
measure: Level/severity of schizophrenia symptoms: Clinical rating scales scores (PANSS, CGI-S, PSP, WoRQ, NSA-4, HoNOS)
timeFrame: Observational visit Day 1
measure: Patient health-related quality of life (HRQoL) questionnaires
timeFrame: Observational visit Day 1
measure: Caregiver's burden as assessed by questionnaires
timeFrame: Observational visit Day 1
Other outcomes:
Locations:
city: Epping
country: Australia
state: New South Wales
city: Everton Park
country: Australia
state: Queensland
city: Brno, Jihormoravsky Kraj
country: Czech Republic
city: Brno
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Plzen
country: Czech Republic
city: Praha 10
country: Czech Republic
city: Praha 10
country: Czech Republic
city: Praha 2
country: Czech Republic
city: Praha 8 - Bohnice
country: Czech Republic
city: Praha
country: Czech Republic
city: Praha
country: Czech Republic
city: Prerov
country: Czech Republic
city: Bohars
country: France
city: Bron
country: France
city: Brumath
country: France
city: Colombes
country: France
city: Digne Les Bains
country: France
city: Fitz James
country: France
city: Henin Beaumont
country: France
city: Leyme
country: France
city: Lille
country: France
city: Montauban
country: France
city: Montpellier
country: France
city: Neuilly Sur Marne
country: France
city: Novillars
country: France
city: Paris
country: France
city: Poitiers
country: France
city: Pontarlier
country: France
city: Provins
country: France
city: Reims
country: France
city: Rennes
country: France
city: Saint Egreve
country: France
city: Saint Nazaire
country: France
city: Sens
country: France
city: Verdun
country: France
city: Chieti
country: Italy
state: Abruzzo
city: L'Aquila
country: Italy
state: Abruzzo
city: Roggiano Gravina
country: Italy
state: Calabria
city: Salerno
country: Italy
state: Campania
city: Solofra
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Modena
country: Italy
state: Emilia-Romagna
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: Bergamo
country: Italy
state: Lombardia
city: Brescia
country: Italy
state: Lombardia
city: Legnago
country: Italy
state: Lombardia
city: Monza
country: Italy
state: Lombardia
city: Pieve Di Coriano
country: Italy
state: Lombardia
city: Varese
country: Italy
state: Lombardia
city: Campobasso
country: Italy
state: Molise
city: Novara
country: Italy
state: Piemonte
city: Foggia
country: Italy
state: Puglia
city: Adrano
country: Italy
state: Sicilia
city: Lido Di Camaiore
country: Italy
state: Toscana
city: Pisa
country: Italy
state: Toscana
city: Siena
country: Italy
state: Toscana
city: Aosta
country: Italy
state: Valle D'Aosta
city: Kemerovo
country: Russian Federation
city: Lipetsk
country: Russian Federation
city: Moscow Region
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Petrozavodsk
country: Russian Federation
city: Samara
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Talagi
country: Russian Federation
city: Langreo
country: Spain
state: Asturias
city: Hospitalet de Llobregat
country: Spain
state: Barcelona
city: Santander
country: Spain
state: Cantabria
city: Torrelavega
country: Spain
state: Cantabria
city: Manacor
country: Spain
state: Islas Baleares
city: Coruña
country: Spain
state: La Coruña
city: Alcalá de Henares
country: Spain
state: Madrid
city: Arganda del Rey
country: Spain
state: Madrid
city: Majadahonda
country: Spain
state: Madrid
city: Pamploma
country: Spain
state: Navarra
city: Mos
country: Spain
state: Pontevedra
city: Vigo
country: Spain
state: Pontevedra
city: Dos Hermanas
country: Spain
state: Sevilla
city: Reus
country: Spain
state: Tarragona
city: Vitoria
country: Spain
state: Vizcaya
city: Almeria
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Toledo
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
city: Ankara
country: Turkey
city: Diyarbakir
country: Turkey
city: Gaziantep
country: Turkey
city: İstanbul
country: Turkey
city: Istanbul
country: Turkey
city: Kocaeli
country: Turkey
city: Manisa
country: Turkey
city: Mersin
country: Turkey
city: Samsun
country: Turkey
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: