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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01959659