A Non-Interventional Study of Patients With Persistent Symptoms of Schizophrenia to Describe Medical Resource Utilization and Burden of Illness

NCT01959659 | Completed

• 1 other identifier: MN28222
• Study Type: observational
• Target: 1,431
• Locations: 7 countries
• Sites: 107

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Medical resource utilization (in-/out-patient hospital services, community-based day service, other health care contacts) of patients with persistent symptoms of schizophrenia

  in the 3 to 12 months prior to screening

Secondary Outcomes (3)

• Level/severity of schizophrenia symptoms: Clinical rating scales scores (PANSS, CGI-S, PSP, WoRQ, NSA-4, HoNOS)

  Observational visit Day 1

• Patient health-related quality of life (HRQoL) questionnaires

  Observational visit Day 1

• Caregiver's burden as assessed by questionnaires

  Observational visit Day 1

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (107)

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Epping, New South Wales, 3076, Australia

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Everton Park, Queensland, 4053, Australia

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Brno, 615 00, Czechia

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Brno, Jihormoravsky Kraj, 625 00, Czechia

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Hradec Králové, 50009, Czechia

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Olomouc, 77520, Czechia

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Pilsen, 312 00, Czechia

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Prague, 100 00, Czechia

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Prague, 102 00, Czechia

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Prague, 110 00, Czechia

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Prague, 128 08, Czechia

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Prague, 190 00, Czechia

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Praha 8 - Bohnice, 181 03, Czechia

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Přerov, 750 01, Czechia

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Bohars, 29820, France

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Bron, 69677, France

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Brumath, 67173, France

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Colombes, 92701, France

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Digne-les-Bains, 04003, France

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Fitz-James, 60600, France

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Hénin-Beaumont, 062251, France

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Leyme, 46120, France

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Lille, 59000, France

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Montauban, 82013, France

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Montpellier, 34295, France

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Neuilly-sur-Marne, 93332, France

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Novillars, 25220, France

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Paris, 75014, France

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Poitiers, 86021, France

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Pontarlier, 25304, France

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Provins, 77488, France

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Reims, 51092, France

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Rennes, 35703, France

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Saint-Égrève, 38521, France

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Saint-Nazaire, 44606, France

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Sens, 89100, France

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Verdun, 55107, France

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Chieti, Abruzzo, 66100, Italy

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L’Aquila, Abruzzo, 67100, Italy

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Aosta, Aosta Valley, 11010, Italy

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Foggia, Apulia, 71100, Italy

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Roggiano Gravina, Calabria, 87017, Italy

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Salerno, Campania, 84098, Italy

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Solofra, Campania, 83029, Italy

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Bologna, Emilia-Romagna, 40133, Italy

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Modena, Emilia-Romagna, 41100, Italy

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Rome, Lazio, 00135, Italy

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Rome, Lazio, 00185, Italy

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Rome, Lazio, 00189, Italy

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Genoa, Liguria, 16132, Italy

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Bergamo, Lombardy, 24123, Italy

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Brescia, Lombardy, 25125, Italy

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Legnago, Lombardy, 37045, Italy

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Monza, Lombardy, 20900, Italy

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Pieve di Coriano, Lombardy, 46020, Italy

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Varese, Lombardy, 21100, Italy

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Campobasso, Molise, 86100, Italy

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Novara, Piedmont, 28100, Italy

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Adrano, Sicily, 95031, Italy

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Lido di Camaiore, Tuscany, 55043, Italy

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Pisa, Tuscany, 56100, Italy

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Siena, Tuscany, 53100, Italy

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Kemerovo, 650036, Russia

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Lipetsk, 399313, Russia

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Moscow, 107076, Russia

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Moscow, 115522, Russia

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Moscow, 127083, Russia

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Moscow Region, 142601, Russia

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Nizhny Novgorod, 603155, Russia

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Petrozavodsk, 186131, Russia

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Saint Petersburg, 190121, Russia

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Saint Petersburg, 194044, Russia

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Samara, 443016, Russia

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Talagi, 163530, Russia

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Almería, Almeria, 4600, Spain

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Manacor, Balearic Islands, 07500, Spain

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Barcelona, Barcelona, 08025, Spain

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Barcelona, Barcelona, 08830, Spain

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Santander, Cantabria, 39008, Spain

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Torrelavega, Cantabria, 39300, Spain

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A Coruña, La Coruña, 15001, Spain

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Alcalá de Henares, Madrid, 28806, Spain

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Arganda, Madrid, 28500, Spain

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Madrid, Madrid, 28006, Spain

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Majadahonda, Madrid, 28222, Spain

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Málaga, Malaga, 29010, Spain

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Pamploma, Navarre, 31014, Spain

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Mos, Pontevedra, 36415, Spain

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Vigo, Pontevedra, 36214, Spain

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Langreo, Principality of Asturias, 33900, Spain

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Dos Hermanas, Sevilla, 41700, Spain

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Reus, Tarragona, 43206, Spain

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Toledo, Toledo, 45006, Spain

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Valencia, Valencia, 46010, Spain

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Valencia, Valencia, 46026, Spain

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Vitoria-Gasteiz, Vizcaya, 01004, Spain

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Zaragoza, Zaragoza, 50018, Spain

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Ankara, 06100, Turkey (Türkiye)

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Diyarbakır, 21280, Turkey (Türkiye)

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Gaziantep, 27310, Turkey (Türkiye)

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Istanbul, 34147, Turkey (Türkiye)

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Istanbul, 34390, Turkey (Türkiye)

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Kocaeli, 41380, Turkey (Türkiye)

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Manisa, 45030, Turkey (Türkiye)

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Mersin, 33169, Turkey (Türkiye)

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Samsun, 55139, Turkey (Türkiye)

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MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 10, 2013
• Study Start: May 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

AU (2); IT (25); FR (23); CZ (12); RU (12); ES (24); TU (9)