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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01959659




Registration number
NCT01959659
Ethics application status
Date submitted
26/09/2013
Date registered
10/10/2013
Date last updated
2/11/2016

Titles & IDs
Public title
A Non-Interventional Study of Patients With Persistent Symptoms of Schizophrenia to Describe Medical Resource Utilization and Burden of Illness
Scientific title
Secondary ID [1] 0 0
MN28222
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cohort -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Medical resource utilization (in-/out-patient hospital services, community-based day service, other health care contacts) of patients with persistent symptoms of schizophrenia
Timepoint [1] 0 0
in the 3 to 12 months prior to screening
Secondary outcome [1] 0 0
Level/severity of schizophrenia symptoms: Clinical rating scales scores (PANSS, CGI-S, PSP, WoRQ, NSA-4, HoNOS)
Timepoint [1] 0 0
Observational visit Day 1
Secondary outcome [2] 0 0
Patient health-related quality of life (HRQoL) questionnaires
Timepoint [2] 0 0
Observational visit Day 1
Secondary outcome [3] 0 0
Caregiver's burden as assessed by questionnaires
Timepoint [3] 0 0
Observational visit Day 1

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Acute exacerbation of schizophrenia within the last 3 months prior to enrolment

- Enrolment in an interventional study

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2014
Sample size
Target
Accrual to date
Final
1431
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
- Epping
Recruitment hospital [2] 0 0
- Everton Park
Recruitment postcode(s) [1] 0 0
3076 - Epping
Recruitment postcode(s) [2] 0 0
4053 - Everton Park
Recruitment outside Australia
Country [1] 0 0
Czech Republic
State/province [1] 0 0
Brno, Jihormoravsky Kraj
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Brno
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Hradec Kralove
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Olomouc
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Plzen
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Praha 10
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Praha 2
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Praha 8 - Bohnice
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Praha
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Prerov
Country [11] 0 0
France
State/province [11] 0 0
Bohars
Country [12] 0 0
France
State/province [12] 0 0
Bron
Country [13] 0 0
France
State/province [13] 0 0
Brumath
Country [14] 0 0
France
State/province [14] 0 0
Colombes
Country [15] 0 0
France
State/province [15] 0 0
Digne Les Bains
Country [16] 0 0
France
State/province [16] 0 0
Fitz James
Country [17] 0 0
France
State/province [17] 0 0
Henin Beaumont
Country [18] 0 0
France
State/province [18] 0 0
Leyme
Country [19] 0 0
France
State/province [19] 0 0
Lille
Country [20] 0 0
France
State/province [20] 0 0
Montauban
Country [21] 0 0
France
State/province [21] 0 0
Montpellier
Country [22] 0 0
France
State/province [22] 0 0
Neuilly Sur Marne
Country [23] 0 0
France
State/province [23] 0 0
Novillars
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
France
State/province [25] 0 0
Poitiers
Country [26] 0 0
France
State/province [26] 0 0
Pontarlier
Country [27] 0 0
France
State/province [27] 0 0
Provins
Country [28] 0 0
France
State/province [28] 0 0
Reims
Country [29] 0 0
France
State/province [29] 0 0
Rennes
Country [30] 0 0
France
State/province [30] 0 0
Saint Egreve
Country [31] 0 0
France
State/province [31] 0 0
Saint Nazaire
Country [32] 0 0
France
State/province [32] 0 0
Sens
Country [33] 0 0
France
State/province [33] 0 0
Verdun
Country [34] 0 0
Italy
State/province [34] 0 0
Abruzzo
Country [35] 0 0
Italy
State/province [35] 0 0
Calabria
Country [36] 0 0
Italy
State/province [36] 0 0
Campania
Country [37] 0 0
Italy
State/province [37] 0 0
Emilia-Romagna
Country [38] 0 0
Italy
State/province [38] 0 0
Lazio
Country [39] 0 0
Italy
State/province [39] 0 0
Liguria
Country [40] 0 0
Italy
State/province [40] 0 0
Lombardia
Country [41] 0 0
Italy
State/province [41] 0 0
Molise
Country [42] 0 0
Italy
State/province [42] 0 0
Piemonte
Country [43] 0 0
Italy
State/province [43] 0 0
Puglia
Country [44] 0 0
Italy
State/province [44] 0 0
Sicilia
Country [45] 0 0
Italy
State/province [45] 0 0
Toscana
Country [46] 0 0
Italy
State/province [46] 0 0
Valle D'Aosta
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Kemerovo
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Lipetsk
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Moscow Region
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Moscow
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Nizhny Novgorod
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Petrozavodsk
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Samara
Country [54] 0 0
Russian Federation
State/province [54] 0 0
St Petersburg
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Talagi
Country [56] 0 0
Spain
State/province [56] 0 0
Asturias
Country [57] 0 0
Spain
State/province [57] 0 0
Barcelona
Country [58] 0 0
Spain
State/province [58] 0 0
Cantabria
Country [59] 0 0
Spain
State/province [59] 0 0
Islas Baleares
Country [60] 0 0
Spain
State/province [60] 0 0
La Coruña
Country [61] 0 0
Spain
State/province [61] 0 0
Madrid
Country [62] 0 0
Spain
State/province [62] 0 0
Navarra
Country [63] 0 0
Spain
State/province [63] 0 0
Pontevedra
Country [64] 0 0
Spain
State/province [64] 0 0
Sevilla
Country [65] 0 0
Spain
State/province [65] 0 0
Tarragona
Country [66] 0 0
Spain
State/province [66] 0 0
Vizcaya
Country [67] 0 0
Spain
State/province [67] 0 0
Almeria
Country [68] 0 0
Spain
State/province [68] 0 0
Malaga
Country [69] 0 0
Spain
State/province [69] 0 0
Toledo
Country [70] 0 0
Spain
State/province [70] 0 0
Valencia
Country [71] 0 0
Spain
State/province [71] 0 0
Zaragoza
Country [72] 0 0
Turkey
State/province [72] 0 0
Ankara
Country [73] 0 0
Turkey
State/province [73] 0 0
Diyarbakir
Country [74] 0 0
Turkey
State/province [74] 0 0
Gaziantep
Country [75] 0 0
Turkey
State/province [75] 0 0
Istanbul
Country [76] 0 0
Turkey
State/province [76] 0 0
Kocaeli
Country [77] 0 0
Turkey
State/province [77] 0 0
Manisa
Country [78] 0 0
Turkey
State/province [78] 0 0
Mersin
Country [79] 0 0
Turkey
State/province [79] 0 0
Samsun

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01959659
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01959659