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

November 1, 2016 updated by: Hoffmann-La Roche
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1431

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Epping, New South Wales, Australia, 3076
    • Queensland
      • Everton Park, Queensland, Australia, 4053
  • Czech Republic
      • Brno, Czech Republic, 615 00
      • Brno, Jihormoravsky Kraj, Czech Republic, 625 00
      • Hradec Kralove, Czech Republic, 50009
      • Olomouc, Czech Republic, 77520
      • Plzen, Czech Republic, 312 00
      • Praha, Czech Republic, 110 00
      • Praha, Czech Republic, 190 00
      • Praha 10, Czech Republic, 100 00
      • Praha 10, Czech Republic, 102 00
      • Praha 2, Czech Republic, 128 08
      • Praha 8 - Bohnice, Czech Republic, 181 03
      • Prerov, Czech Republic, 750 01
  • France
      • Bohars, France, 29820
      • Bron, France, 69677
      • Brumath, France, 67173
      • Colombes, France, 92701
      • Digne Les Bains, France, 04003
      • Fitz James, France, 60600
      • Henin Beaumont, France, 062251
      • Leyme, France, 46120
      • Lille, France, 59000
      • Montauban, France, 82013
      • Montpellier, France, 34295
      • Neuilly Sur Marne, France, 93332
      • Novillars, France, 25220
      • Paris, France, 75014
      • Poitiers, France, 86021
      • Pontarlier, France, 25304
      • Provins, France, 77488
      • Reims, France, 51092
      • Rennes, France, 35703
      • Saint Egreve, France, 38521
      • Saint Nazaire, France, 44606
      • Sens, France, 89100
      • Verdun, France, 55107
  • Italy
    • Abruzzo
      • Chieti, Abruzzo, Italy, 66100
      • L'Aquila, Abruzzo, Italy, 67100
    • Calabria
      • Roggiano Gravina, Calabria, Italy, 87017
    • Campania
      • Salerno, Campania, Italy, 84098
      • Solofra, Campania, Italy, 83029
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40133
      • Modena, Emilia-Romagna, Italy, 41100
    • Lazio
      • Roma, Lazio, Italy, 00189
      • Roma, Lazio, Italy, 00135
      • Roma, Lazio, Italy, 00185
    • Liguria
      • Genova, Liguria, Italy, 16132
    • Lombardia
      • Bergamo, Lombardia, Italy, 24123
      • Brescia, Lombardia, Italy, 25125
      • Legnago, Lombardia, Italy, 37045
      • Monza, Lombardia, Italy, 20900
      • Pieve Di Coriano, Lombardia, Italy, 46020
      • Varese, Lombardia, Italy, 21100
    • Molise
      • Campobasso, Molise, Italy, 86100
    • Piemonte
      • Novara, Piemonte, Italy, 28100
    • Puglia
      • Foggia, Puglia, Italy, 71100
    • Sicilia
      • Adrano, Sicilia, Italy, 95031
    • Toscana
      • Lido Di Camaiore, Toscana, Italy, 55043
      • Pisa, Toscana, Italy, 56100
      • Siena, Toscana, Italy, 53100
    • Valle D'Aosta
      • Aosta, Valle D'Aosta, Italy, 11010
  • Russian Federation
      • Kemerovo, Russian Federation, 650036
      • Lipetsk, Russian Federation, 399313
      • Moscow, Russian Federation, 115522
      • Moscow, Russian Federation, 107076
      • Moscow, Russian Federation, 127083
      • Moscow Region, Russian Federation, 142601
      • Nizhny Novgorod, Russian Federation, 603155
      • Petrozavodsk, Russian Federation, 186131
      • Samara, Russian Federation, 443016
      • St Petersburg, Russian Federation, 194044
      • St Petersburg, Russian Federation, 190121
      • Talagi, Russian Federation, 163530
  • Spain
      • Almeria, Spain, 4600
      • Barcelona, Spain, 08025
      • Barcelona, Spain, 08830
      • Madrid, Spain, 28006
      • Malaga, Spain, 29010
      • Toledo, Spain, 45006
      • Valencia, Spain, 46026
      • Valencia, Spain, 46010
      • Zaragoza, Spain, 50018
    • Asturias
      • Langreo, Asturias, Spain, 33900
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
    • Cantabria
      • Santander, Cantabria, Spain, 39008
      • Torrelavega, Cantabria, Spain, 39300
    • Islas Baleares
      • Manacor, Islas Baleares, Spain, 07500
    • La Coruña
      • Coruña, La Coruña, Spain, 15001
    • Madrid
      • Alcalá de Henares, Madrid, Spain, 28806
      • Arganda del Rey, Madrid, Spain, 28500
      • Majadahonda, Madrid, Spain, 28222
    • Navarra
      • Pamploma, Navarra, Spain, 31014
    • Pontevedra
      • Mos, Pontevedra, Spain, 36415
      • Vigo, Pontevedra, Spain, 36214
    • Sevilla
      • Dos Hermanas, Sevilla, Spain, 41700
    • Tarragona
      • Reus, Tarragona, Spain, 43206
    • Vizcaya
      • Vitoria, Vizcaya, Spain, 01004
  • Turkey
      • Ankara, Turkey, 06100
      • Diyarbakir, Turkey, 21280
      • Gaziantep, Turkey, 27310
      • Istanbul, Turkey, 34390
      • Kocaeli, Turkey, 41380
      • Manisa, Turkey, 45030
      • Mersin, Turkey, 33169
      • Samsun, Turkey, 55139
      • İstanbul, Turkey, 34147

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Medical resource utilization (in-/out-patient hospital services, community-based day service, other health care contacts) of patients with persistent symptoms of schizophrenia
Time Frame: in the 3 to 12 months prior to screening
in the 3 to 12 months prior to screening

Secondary Outcome Measures

Outcome Measure
Time Frame
Level/severity of schizophrenia symptoms: Clinical rating scales scores (PANSS, CGI-S, PSP, WoRQ, NSA-4, HoNOS)
Time Frame: Observational visit Day 1
Observational visit Day 1
Patient health-related quality of life (HRQoL) questionnaires
Time Frame: Observational visit Day 1
Observational visit Day 1
Caregiver's burden as assessed by questionnaires
Time Frame: Observational visit Day 1
Observational visit Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

September 26, 2013

First Submitted That Met QC Criteria

October 8, 2013

First Posted (Estimate)

October 10, 2013

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MN28222

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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