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SchizophreniaNCT01959659

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

An observational study of Schizophrenia, run by Hoffmann-La Roche at 107 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia
How many people
1,431 participants
Where
107 sitesin 7 countries
Study dates
May 2013to Apr 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

107 sites in 7 countries.

107 sites in 7 countries

Italy25 sites

  • Study site

    Adrano, Sicily, 95031

  • Study site

    Aosta, Aosta Valley, 11010

  • Study site

    Bergamo, Lombardy, 24123

  • Study site

    Bologna, Emilia-Romagna, 40133

  • Study site

    Brescia, Lombardy, 25125

  • Study site

    Campobasso, Molise, 86100

  • Study site

    Chieti, Abruzzo, 66100

  • Study site

    Foggia, Apulia, 71100

  • Study site

    Genoa, Liguria, 16132

  • Study site

    L’Aquila, Abruzzo, 67100

  • Study site

    Legnago, Lombardy, 37045

  • Study site

    Lido di Camaiore, Tuscany, 55043

  • Study site

    Modena, Emilia-Romagna, 41100

  • Study site

    Monza, Lombardy, 20900

  • Study site

    Novara, Piedmont, 28100

  • Study site

    Pieve di Coriano, Lombardy, 46020

  • Study site

    Pisa, Tuscany, 56100

  • Study site

    Roggiano Gravina, Calabria, 87017

  • Study site

    Rome, Lazio, 00135

  • Study site

    Rome, Lazio, 00185

  • Study site

    Rome, Lazio, 00189

  • Study site

    Salerno, Campania, 84098

  • Study site

    Siena, Tuscany, 53100

  • Study site

    Solofra, Campania, 83029

  • Study site

    Varese, Lombardy, 21100

Other trials in Italy

Spain24 sites

  • Study site

    A Coruña, La Coruña, 15001

  • Study site

    Alcalá de Henares, Madrid, 28806

  • Study site

    Almería, Almeria, 4600

  • Study site

    Arganda, Madrid, 28500

  • Study site

    Barcelona, Barcelona, 08025

  • Study site

    Barcelona, Barcelona, 08830

  • Study site

    Dos Hermanas, Sevilla, 41700

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Langreo, Principality of Asturias, 33900

  • Study site

    Madrid, Madrid, 28006

  • Study site

    Majadahonda, Madrid, 28222

  • Study site

    Málaga, Malaga, 29010

  • Study site

    Manacor, Balearic Islands, 07500

  • Study site

    Mos, Pontevedra, 36415

  • Study site

    Pamploma, Navarre, 31014

  • Study site

    Reus, Tarragona, 43206

  • Study site

    Santander, Cantabria, 39008

  • Study site

    Toledo, Toledo, 45006

  • Study site

    Torrelavega, Cantabria, 39300

  • Study site

    Valencia, Valencia, 46010

  • Study site

    Valencia, Valencia, 46026

  • Study site

    Vigo, Pontevedra, 36214

  • Study site

    Vitoria-Gasteiz, Vizcaya, 01004

  • Study site

    Zaragoza, Zaragoza, 50018

Other trials in Spain

France23 sites

  • Study site

    Bohars, 29820

  • Study site

    Bron, 69677

  • Study site

    Brumath, 67173

  • Study site

    Colombes, 92701

  • Study site

    Digne-les-Bains, 04003

  • Study site

    Fitz-James, 60600

  • Study site

    Hénin-Beaumont, 062251

  • Study site

    Leyme, 46120

  • Study site

    Lille, 59000

  • Study site

    Montauban, 82013

  • Study site

    Montpellier, 34295

  • Study site

    Neuilly-sur-Marne, 93332

  • Study site

    Novillars, 25220

  • Study site

    Paris, 75014

  • Study site

    Poitiers, 86021

  • Study site

    Pontarlier, 25304

  • Study site

    Provins, 77488

  • Study site

    Reims, 51092

  • Study site

    Rennes, 35703

  • Study site

    Saint-Égrève, 38521

  • Study site

    Saint-Nazaire, 44606

  • Study site

    Sens, 89100

  • Study site

    Verdun, 55107

Other trials in France

Czechia12 sites

  • Study site

    Brno, 615 00

  • Study site

    Brno, Jihormoravsky Kraj, 625 00

  • Study site

    Hradec Králové, 50009

  • Study site

    Olomouc, 77520

  • Study site

    Pilsen, 312 00

  • Study site

    Prague, 100 00

  • Study site

    Prague, 102 00

  • Study site

    Prague, 110 00

  • Study site

    Prague, 128 08

  • Study site

    Prague, 190 00

  • Study site

    Praha 8 - Bohnice, 181 03

  • Study site

    Přerov, 750 01

Other trials in Czechia

Russia12 sites

  • Study site

    Kemerovo, 650036

  • Study site

    Lipetsk, 399313

  • Study site

    Moscow, 107076

  • Study site

    Moscow, 115522

  • Study site

    Moscow, 127083

  • Study site

    Moscow Region, 142601

  • Study site

    Nizhny Novgorod, 603155

  • Study site

    Petrozavodsk, 186131

  • Study site

    Saint Petersburg, 190121

  • Study site

    Saint Petersburg, 194044

  • Study site

    Samara, 443016

  • Study site

    Talagi, 163530

Other trials in Russia

Turkey (Türkiye)9 sites

  • Study site

    Ankara, 06100

  • Study site

    Diyarbakır, 21280

  • Study site

    Gaziantep, 27310

  • Study site

    Istanbul, 34147

  • Study site

    Istanbul, 34390

  • Study site

    Kocaeli, 41380

  • Study site

    Manisa, 45030

  • Study site

    Mersin, 33169

  • Study site

    Samsun, 55139

Other trials in Turkey (Türkiye)

Australia2 sites

  • Study site

    Epping, New South Wales, 3076

  • Study site

    Everton Park, Queensland, 4053

Other trials in Australia

About this study

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
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01959659
Study groupRoleWhat they receive
CohortNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: in the 3 to 12 months prior to screening

Secondary outcomes (3)

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

    Measured: Observational visit Day 1

  2. Patient health-related quality of life (HRQoL) questionnaires

    Measured: Observational visit Day 1

  3. Caregiver's burden as assessed by questionnaires

    Measured: Observational visit Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionApr 2014
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,431 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01959659
Sponsor's protocol ID
MN28222
Status last verified
Nov 2016
First submitted
26 Sep 2013
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenia, run by Hoffmann-La Roche at 107 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in Italy, Spain, France, Czechia, Russia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01959659.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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