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

NCT ID: NCT01959659

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

1431 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-04-30

Brief Summary

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

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.

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

RETROSPECTIVE

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

* 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

Exclusion Criteria

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

Epping, New South Wales, Australia

Site Status

Everton Park, Queensland, Australia

Site Status

Brno, , Czechia

Site Status

Brno, Jihormoravsky Kraj, , Czechia

Site Status

Hradec Králové, , Czechia

Site Status

Olomouc, , Czechia

Site Status

Pilsen, , Czechia

Site Status

Prague, , Czechia

Site Status

Prague, , Czechia

Site Status

Prague, , Czechia

Site Status

Prague, , Czechia

Site Status

Prague, , Czechia

Site Status

Praha 8 - Bohnice, , Czechia

Site Status

Přerov, , Czechia

Site Status

Bohars, , France

Site Status

Bron, , France

Site Status

Brumath, , France

Site Status

Colombes, , France

Site Status

Digne-les-Bains, , France

Site Status

Fitz-James, , France

Site Status

Hénin-Beaumont, , France

Site Status

Leyme, , France

Site Status

Lille, , France

Site Status

Montauban, , France

Site Status

Montpellier, , France

Site Status

Neuilly-sur-Marne, , France

Site Status

Novillars, , France

Site Status

Paris, , France

Site Status

Poitiers, , France

Site Status

Pontarlier, , France

Site Status

Provins, , France

Site Status

Reims, , France

Site Status

Rennes, , France

Site Status

Saint-Égrève, , France

Site Status

Saint-Nazaire, , France

Site Status

Sens, , France

Site Status

Verdun, , France

Site Status

Chieti, Abruzzo, Italy

Site Status

L’Aquila, Abruzzo, Italy

Site Status

Aosta, Aosta Valley, Italy

Site Status

Foggia, Apulia, Italy

Site Status

Roggiano Gravina, Calabria, Italy

Site Status

Salerno, Campania, Italy

Site Status

Solofra, Campania, Italy

Site Status

Bologna, Emilia-Romagna, Italy

Site Status

Modena, Emilia-Romagna, Italy

Site Status

Rome, Lazio, Italy

Site Status

Rome, Lazio, Italy

Site Status

Rome, Lazio, Italy

Site Status

Genoa, Liguria, Italy

Site Status

Bergamo, Lombardy, Italy

Site Status

Brescia, Lombardy, Italy

Site Status

Legnago, Lombardy, Italy

Site Status

Monza, Lombardy, Italy

Site Status

Pieve di Coriano, Lombardy, Italy

Site Status

Varese, Lombardy, Italy

Site Status

Campobasso, Molise, Italy

Site Status

Novara, Piedmont, Italy

Site Status

Adrano, Sicily, Italy

Site Status

Lido di Camaiore, Tuscany, Italy

Site Status

Pisa, Tuscany, Italy

Site Status

Siena, Tuscany, Italy

Site Status

Kemerovo, , Russia

Site Status

Lipetsk, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow Region, , Russia

Site Status

Nizhny Novgorod, , Russia

Site Status

Petrozavodsk, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Samara, , Russia

Site Status

Talagi, , Russia

Site Status

Almería, Almeria, Spain

Site Status

Manacor, Balearic Islands, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Santander, Cantabria, Spain

Site Status

Torrelavega, Cantabria, Spain

Site Status

A Coruña, La Coruña, Spain

Site Status

Alcalá de Henares, Madrid, Spain

Site Status

Arganda, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Majadahonda, Madrid, Spain

Site Status

Málaga, Malaga, Spain

Site Status

Pamploma, Navarre, Spain

Site Status

Mos, Pontevedra, Spain

Site Status

Vigo, Pontevedra, Spain

Site Status

Langreo, Principality of Asturias, Spain

Site Status

Dos Hermanas, Sevilla, Spain

Site Status

Reus, Tarragona, Spain

Site Status

Toledo, Toledo, Spain

Site Status

Valencia, Valencia, Spain

Site Status

Valencia, Valencia, Spain

Site Status

Vitoria-Gasteiz, Vizcaya, Spain

Site Status

Zaragoza, Zaragoza, Spain

Site Status

Ankara, , Turkey (Türkiye)

Site Status

Diyarbakır, , Turkey (Türkiye)

Site Status

Gaziantep, , Turkey (Türkiye)

Site Status

Istanbul, , Turkey (Türkiye)

Site Status

Istanbul, , Turkey (Türkiye)

Site Status

Kocaeli, , Turkey (Türkiye)

Site Status

Manisa, , Turkey (Türkiye)

Site Status

Mersin, , Turkey (Türkiye)

Site Status

Samsun, , Turkey (Türkiye)

Site Status

Countries

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

Australia Czechia France Italy Russia Spain Turkey (Türkiye)

Other Identifiers

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

MN28222

Identifier Type: -

Identifier Source: org_study_id