An Non-Interventional Study of Patients With Persistent Symptoms of Schizophrenia

NCT01634542 | Completed

• 1 other identifier: MN28151
• Study Type: observational
• Target: 1,433
• Locations: 8 countries
• Sites: 148

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Course of illness: Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores

  from baseline to Month 24

Secondary Outcomes (3)

• Frequency/characteristics (PANSS) of patients with diagnosis of schizophrenia of >/= 12 months duration before baseline

  at screening (approximately 18 months)

• Duration/severity of symptoms of schizophrenia according to Personal Social Performance Scale (PSP) / Health Related Quality of Life (HRQoL) questionnaire

  24 months

• Medical resource utilization/costs

  24 months

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (148)

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Buenos Aires, C1275AHG, Argentina

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Caba, Argentina

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La Plata, 1900, Argentina

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Goiânia, Goiás, 74093-040, Brazil

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Curitiba, Paraná, 80240-280, Brazil

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São Paulo, São Paulo, 04044-000, Brazil

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São Paulo, São Paulo, 05403-000, Brazil

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Medicine Hat, Alberta, T1B 4E7, Canada

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Vancouver, British Columbia, V5Z 1N1, Canada

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Chatam, Ontario, N7L 1C1, Canada

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Mississauga, Ontario, L5M 4N4, Canada

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Windsor, Ontario, N9C 3Z4, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Québec, Quebec, G1R 2W8, Canada

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Verdun, Quebec, H4H 1R3, Canada

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Aix-en-Provence, 13100, France

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Chaumont, 52904, France

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Colmar, 68024, France

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Corbeil-Essonnes, 91106, France

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Issy-les-Moulineaux, 92133, France

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Lille, 59000, France

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Lyon, 69006, France

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Marseille, 13005, France

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Marseille, 13008, France

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Marseille, 13274, France

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Marseille, 13391, France

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Montberon, 31140, France

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Montebeliard, 25200, France

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Montpellier, 34295, France

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Nantes, 44093, France

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Nice, 06000, France

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Nice, 06100, France

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Paris, 75014, France

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Paris, 75015, France

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Paris, 75571, France

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Poitiers, 86021, France

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Rennes, 35703, France

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Rouffach, 68250, France

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Saint-Cyr-au-Mont-d'Or, 69450, France

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Tassin-la-Demi-Lune, 69160, France

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Toulouse, 31200, France

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Verdun, 55107, France

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Aachen, 52062, Germany

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Aachen, 52074, Germany

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Alzey, 55232, Germany

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Augsburg, 86156, Germany

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Bad Zwischenahn, 26160, Germany

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Berlin, 10117, Germany

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Berlin, 12526, Germany

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Berlin, 13088, Germany

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Berlin, 13187, Germany

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Bochum, 44792, Germany

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Cologne, 50996, Germany

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Dortmund, 44287, Germany

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Dresden, 01307, Germany

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Düsseldorf, 40629, Germany

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Ellwangen, 73479, Germany

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Essen, 45136, Germany

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Essen, 45276, Germany

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Grünstadt, 67269, Germany

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Halle, 06112, Germany

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Hamburg, 20246, Germany

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Hamburg, 22179, Germany

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Hamburg, 22419, Germany

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Hamburg, 22769, Germany

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Homburg/Saar, 66421, Germany

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Jena, 07743, Germany

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Koeln-Pulheim, 50259, Germany

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Leipzig, 04275, Germany

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Leipzig, 04357, Germany

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Magdeburg, 39120, Germany

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Mainz, 55131, Germany

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Mannheim, 68159, Germany

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Marburg, 35033, Germany

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Mittweida, 09648, Germany

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Oranienburg, 16515, Germany

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Regensburg, 93053, Germany

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Rostock, 18147, Germany

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Siegen, 57072, Germany

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Weinsberg, 74189, Germany

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Westerstede, 26655, Germany

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Bari, Apulia, 70124, Italy

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Catanzaro, Calabria, 88100, Italy

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Bologna, Emilia-Romagna, 40139, Italy

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Trieste, Friuli Venezia Giulia, 34127, Italy

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Udine, Friuli Venezia Giulia, 33100, Italy

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Rome, Lazio, 00100, Italy

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Rome, Lazio, 00133, Italy

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Rome, Lazio, 00135, Italy

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Genoa, Liguria, 16147, Italy

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Cassina Nuova Di Bollate, Lombardy, 20021, Italy

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Gardone V.T., Lombardy, 25063, Italy

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Milan, Lombardy, 20122, Italy

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Milan, Lombardy, 20127, Italy

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Milan, Lombardy, 21100, Italy

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Campobasso, Molise, 86100, Italy

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Bra, Piedmont, 12042, Italy

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Novara, Piedmont, 28100, Italy

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Cagliari, Sardinia, 09127, Italy

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Sassari, Sardinia, 07100, Italy

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Catania, Sicily, 95123, Italy

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Messina, Sicily, 98125, Italy

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Palermo, Sicily, 90129, Italy

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Florence, Tuscany, Italy

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Perugia, Umbria, 06158, Italy

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Conegliano, Veneto, 31015, Italy

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Padua, Veneto, 35128, Italy

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Alcoy, Alicante, 3802, Spain

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Almería, Almeria, 4600, Spain

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Manacor, Balearic Islands, 07500, Spain

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Palma de Mallorca, Balearic Islands, 07014, Spain

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Barcelona, Barcelona, 08025, Spain

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Barcelona, Barcelona, 08830, Spain

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Terrassa, Barcelona, 08221, Spain

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Burgos, Burgos, 9006, Spain

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Santander, Cantabria, 39008, Spain

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Torrelavega, Cantabria, 39300, Spain

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Granada, Granada, 18003, Spain

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A Coruña, La Coruña, 15001, Spain

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Málaga, Malaga, 29010, Spain

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Pamploma, Navarre, 31014, Spain

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Pamplona, Navarre, 31008, Spain

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Palencia, Palencia, 34004, Spain

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Vigo, Pontevedra, 36214, Spain

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Langreo, Principality of Asturias, 33900, Spain

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Soria, Soria, 42005, Spain

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Reus, Tarragona, 43206, Spain

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Valencia, Valencia, 46010, Spain

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Valladolid, Valladolid, 47005, Spain

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Bilbao, Vizcaya, 48300, Spain

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Bilbao, Vizcaya, 48370, Spain

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Vitoria-Gasteiz, Vizcaya, 01004, Spain

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Belfast, BT12 6B, United Kingdom

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Bristol, BS8 2BN, United Kingdom

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Cambridge, CB2 0ST, United Kingdom

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Cheshire, WA2 8WA, United Kingdom

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Cornwall, TR15 2SP, United Kingdom

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Coventry, CV1 4FH, United Kingdom

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Essex, CO15 1LH, United Kingdom

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Glasgow, G12 0XH, United Kingdom

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Hemel Hempstead, HP3 8EH, United Kingdom

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Lincolnshire, NG34 8GG, United Kingdom

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Norfolk, NR1 3RE, United Kingdom

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Nottingham, NG3 6AA, United Kingdom

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Stoke-on-Trent, ST4 6TH, United Kingdom

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Walsall, WS2 9SS, United Kingdom

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Wolverhampton, WV14 0DQ, United Kingdom

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Related Publications (3)

• 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.

  PMID: 31908462 DERIVED

• 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.

  PMID: 30820841 DERIVED

• 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.

  PMID: 30088146 DERIVED

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: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 6, 2012
• Study Start: February 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

IT (26); CA (9); GB (15); FR (27); DE (39); BR (4); ES (25); AR (3)