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

NCT ID: NCT01634542

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1433 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Buenos Aires, , Argentina

Site Status

Caba, , Argentina

Site Status

La Plata, , Argentina

Site Status

Goiânia, Goiás, Brazil

Site Status

Curitiba, Paraná, Brazil

Site Status

São Paulo, São Paulo, Brazil

Site Status

São Paulo, São Paulo, Brazil

Site Status

Medicine Hat, Alberta, Canada

Site Status

Vancouver, British Columbia, Canada

Site Status

Chatam, Ontario, Canada

Site Status

Mississauga, Ontario, Canada

Site Status

Windsor, Ontario, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Québec, Quebec, Canada

Site Status

Verdun, Quebec, Canada

Site Status

Aix-en-Provence, , France

Site Status

Chaumont, , France

Site Status

Colmar, , France

Site Status

Corbeil-Essonnes, , France

Site Status

Issy-les-Moulineaux, , France

Site Status

Lille, , France

Site Status

Lyon, , France

Site Status

Marseille, , France

Site Status

Marseille, , France

Site Status

Marseille, , France

Site Status

Marseille, , France

Site Status

Montberon, , France

Site Status

Montebeliard, , France

Site Status

Montpellier, , France

Site Status

Nantes, , France

Site Status

Nice, , France

Site Status

Nice, , France

Site Status

Paris, , France

Site Status

Paris, , France

Site Status

Paris, , France

Site Status

Poitiers, , France

Site Status

Rennes, , France

Site Status

Rouffach, , France

Site Status

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

Site Status

Tassin-la-Demi-Lune, , France

Site Status

Toulouse, , France

Site Status

Verdun, , France

Site Status

Aachen, , Germany

Site Status

Aachen, , Germany

Site Status

Alzey, , Germany

Site Status

Augsburg, , Germany

Site Status

Bad Zwischenahn, , Germany

Site Status

Berlin, , Germany

Site Status

Berlin, , Germany

Site Status

Berlin, , Germany

Site Status

Berlin, , Germany

Site Status

Bochum, , Germany

Site Status

Cologne, , Germany

Site Status

Dortmund, , Germany

Site Status

Dresden, , Germany

Site Status

Düsseldorf, , Germany

Site Status

Ellwangen, , Germany

Site Status

Essen, , Germany

Site Status

Essen, , Germany

Site Status

Grünstadt, , Germany

Site Status

Halle, , Germany

Site Status

Hamburg, , Germany

Site Status

Hamburg, , Germany

Site Status

Hamburg, , Germany

Site Status

Hamburg, , Germany

Site Status

Homburg/Saar, , Germany

Site Status

Jena, , Germany

Site Status

Koeln-Pulheim, , Germany

Site Status

Leipzig, , Germany

Site Status

Leipzig, , Germany

Site Status

Magdeburg, , Germany

Site Status

Mainz, , Germany

Site Status

Mannheim, , Germany

Site Status

Marburg, , Germany

Site Status

Mittweida, , Germany

Site Status

Oranienburg, , Germany

Site Status

Regensburg, , Germany

Site Status

Rostock, , Germany

Site Status

Siegen, , Germany

Site Status

Weinsberg, , Germany

Site Status

Westerstede, , Germany

Site Status

Bari, Apulia, Italy

Site Status

Catanzaro, Calabria, Italy

Site Status

Bologna, Emilia-Romagna, Italy

Site Status

Trieste, Friuli Venezia Giulia, Italy

Site Status

Udine, Friuli Venezia Giulia, Italy

Site Status

Rome, Lazio, Italy

Site Status

Rome, Lazio, Italy

Site Status

Rome, Lazio, Italy

Site Status

Genoa, Liguria, Italy

Site Status

Cassina Nuova Di Bollate, Lombardy, Italy

Site Status

Gardone V.T., Lombardy, Italy

Site Status

Milan, Lombardy, Italy

Site Status

Milan, Lombardy, Italy

Site Status

Milan, Lombardy, Italy

Site Status

Campobasso, Molise, Italy

Site Status

Bra, Piedmont, Italy

Site Status

Novara, Piedmont, Italy

Site Status

Cagliari, Sardinia, Italy

Site Status

Sassari, Sardinia, Italy

Site Status

Catania, Sicily, Italy

Site Status

Messina, Sicily, Italy

Site Status

Palermo, Sicily, Italy

Site Status

Florence, Tuscany, Italy

Site Status

Perugia, Umbria, Italy

Site Status

Conegliano, Veneto, Italy

Site Status

Padua, Veneto, Italy

Site Status

Alcoy, Alicante, Spain

Site Status

Almería, Almeria, Spain

Site Status

Manacor, Balearic Islands, Spain

Site Status

Palma de Mallorca, Balearic Islands, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

Terrassa, Barcelona, Spain

Site Status

Burgos, Burgos, Spain

Site Status

Santander, Cantabria, Spain

Site Status

Torrelavega, Cantabria, Spain

Site Status

Granada, Granada, Spain

Site Status

A Coruña, La Coruña, Spain

Site Status

Málaga, Malaga, Spain

Site Status

Pamploma, Navarre, Spain

Site Status

Pamplona, Navarre, Spain

Site Status

Palencia, Palencia, Spain

Site Status

Vigo, Pontevedra, Spain

Site Status

Langreo, Principality of Asturias, Spain

Site Status

Soria, Soria, Spain

Site Status

Reus, Tarragona, Spain

Site Status

Valencia, Valencia, Spain

Site Status

Valladolid, Valladolid, Spain

Site Status

Bilbao, Vizcaya, Spain

Site Status

Bilbao, Vizcaya, Spain

Site Status

Vitoria-Gasteiz, Vizcaya, Spain

Site Status

Belfast, , United Kingdom

Site Status

Bristol, , United Kingdom

Site Status

Cambridge, , United Kingdom

Site Status

Cheshire, , United Kingdom

Site Status

Cornwall, , United Kingdom

Site Status

Coventry, , United Kingdom

Site Status

Essex, , United Kingdom

Site Status

Glasgow, , United Kingdom

Site Status

Hemel Hempstead, , United Kingdom

Site Status

Lincolnshire, , United Kingdom

Site Status

Norfolk, , United Kingdom

Site Status

Nottingham, , United Kingdom

Site Status

Stoke-on-Trent, , United Kingdom

Site Status

Walsall, , United Kingdom

Site Status

Wolverhampton, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea Argentina Brazil Canada France Germany Italy Spain United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31908462 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30820841 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30088146 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MN28151

Identifier Type: -

Identifier Source: org_study_id