SchizophreniaNCT01634542
An Non-Interventional Study of Patients With Persistent Symptoms of Schizophrenia
An observational study of Schizophrenia, run by Hoffmann-La Roche at 148 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 1,433 participants
- Where
- 148 sitesin 8 countries
- Study dates
- Feb 2011to Dec 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
148 sites in 8 countries.
148 sites in 8 countries
Germany39 sites
Study site
Aachen, 52062
Study site
Aachen, 52074
Study site
Alzey, 55232
Study site
Augsburg, 86156
Study site
Bad Zwischenahn, 26160
Study site
Berlin, 10117
Study site
Berlin, 12526
Study site
Berlin, 13088
Study site
Berlin, 13187
Study site
Bochum, 44792
Study site
Cologne, 50996
Study site
Dortmund, 44287
Study site
Dresden, 01307
Study site
Düsseldorf, 40629
Study site
Ellwangen, 73479
Study site
Essen, 45136
Study site
Essen, 45276
Study site
Grünstadt, 67269
Study site
Halle, 06112
Study site
Hamburg, 20246
Study site
Hamburg, 22179
Study site
Hamburg, 22419
Study site
Hamburg, 22769
Study site
Homburg/Saar, 66421
Study site
Jena, 07743
Study site
Koeln-Pulheim, 50259
Study site
Leipzig, 04275
Study site
Leipzig, 04357
Study site
Magdeburg, 39120
Study site
Mainz, 55131
Study site
Mannheim, 68159
Study site
Marburg, 35033
Study site
Mittweida, 09648
Study site
Oranienburg, 16515
Study site
Regensburg, 93053
Study site
Rostock, 18147
Study site
Siegen, 57072
Study site
Weinsberg, 74189
Study site
Westerstede, 26655
France27 sites
Study site
Aix-en-Provence, 13100
Study site
Chaumont, 52904
Study site
Colmar, 68024
Study site
Corbeil-Essonnes, 91106
Study site
Issy-les-Moulineaux, 92133
Study site
Lille, 59000
Study site
Lyon, 69006
Study site
Marseille, 13005
Study site
Marseille, 13008
Study site
Marseille, 13274
Study site
Marseille, 13391
Study site
Montberon, 31140
Study site
Montebeliard, 25200
Study site
Montpellier, 34295
Study site
Nantes, 44093
Study site
Nice, 06000
Study site
Nice, 06100
Study site
Paris, 75014
Study site
Paris, 75015
Study site
Paris, 75571
Study site
Poitiers, 86021
Study site
Rennes, 35703
Study site
Rouffach, 68250
Study site
Saint-Cyr-au-Mont-d'Or, 69450
Study site
Tassin-la-Demi-Lune, 69160
Study site
Toulouse, 31200
Study site
Verdun, 55107
Italy26 sites
Study site
Bari, Apulia, 70124
Study site
Bologna, Emilia-Romagna, 40139
Study site
Bra, Piedmont, 12042
Study site
Cagliari, Sardinia, 09127
Study site
Campobasso, Molise, 86100
Study site
Cassina Nuova Di Bollate, Lombardy, 20021
Study site
Catania, Sicily, 95123
Study site
Catanzaro, Calabria, 88100
Study site
Conegliano, Veneto, 31015
Study site
Florence, Tuscany
Study site
Gardone V.T., Lombardy, 25063
Study site
Genoa, Liguria, 16147
Study site
Messina, Sicily, 98125
Study site
Milan, Lombardy, 20122
Study site
Milan, Lombardy, 20127
Study site
Milan, Lombardy, 21100
Study site
Novara, Piedmont, 28100
Study site
Padova, Veneto, 35128
Study site
Palermo, Sicily, 90129
Study site
Perugia, Umbria, 06158
Study site
Rome, Lazio, 00100
Study site
Rome, Lazio, 00133
Study site
Rome, Lazio, 00135
Study site
Sassari, Sardinia, 07100
Study site
Trieste, Friuli Venezia Giulia, 34127
Study site
Udine, Friuli Venezia Giulia, 33100
Spain25 sites
Study site
A Coruña, La Coruña, 15001
Study site
Alcoy, Alicante, 3802
Study site
Almería, Almeria, 4600
Study site
Barcelona, Barcelona, 08025
Study site
Barcelona, Barcelona, 08830
Study site
Bilbao, Vizcaya, 48300
Study site
Bilbao, Vizcaya, 48370
Study site
Burgos, Burgos, 9006
Study site
Granada, Granada, 18003
Study site
Langreo, Principality of Asturias, 33900
Study site
Málaga, Malaga, 29010
Study site
Manacor, Balearic Islands, 07500
Study site
Palencia, Palencia, 34004
Study site
Palma de Mallorca, Balearic Islands, 07014
Study site
Pamploma, Navarre, 31014
Study site
Pamplona, Navarre, 31008
Study site
Reus, Tarragona, 43206
Study site
Santander, Cantabria, 39008
Study site
Soria, Soria, 42005
Study site
Terrassa, Barcelona, 08221
Study site
Torrelavega, Cantabria, 39300
Study site
Valencia, Valencia, 46010
Study site
Valladolid, Valladolid, 47005
Study site
Vigo, Pontevedra, 36214
Study site
Vitoria-Gasteiz, Vizcaya, 01004
United Kingdom15 sites
Study site
Belfast, BT12 6B
Study site
Bristol, BS8 2BN
Study site
Cambridge, CB2 0ST
Study site
Cheshire, WA2 8WA
Study site
Cornwall, TR15 2SP
Study site
Coventry, CV1 4FH
Study site
Essex, CO15 1LH
Study site
Glasgow, G12 0XH
Study site
Hemel Hempstead, HP3 8EH
Study site
Lincolnshire, NG34 8GG
Study site
Norfolk, NR1 3RE
Study site
Nottingham, NG3 6AA
Study site
Stoke-on-Trent, ST4 6TH
Study site
Walsall, WS2 9SS
Study site
Wolverhampton, WV14 0DQ
Canada9 sites
Study site
Chatam, Ontario, N7L 1C1
Study site
Medicine Hat, Alberta, T1B 4E7
Study site
Mississauga, Ontario, L5M 4N4
Study site
Montreal, Quebec, H2L 4M1
Study site
Montreal, Quebec, H3A 1A1
Study site
Québec, Quebec, G1R 2W8
Study site
Vancouver, British Columbia, V5Z 1N1
Study site
Verdun, Quebec, H4H 1R3
Study site
Windsor, Ontario, N9C 3Z4
Brazil4 sites
Study site
Curitiba, Paraná, 80240-280
Study site
Goiânia, Goiás, 74093-040
Study site
São Paulo, São Paulo, 04044-000
Study site
São Paulo, São Paulo, 05403-000
Argentina3 sites
Study site
Buenos Aires, C1275AHG
Study site
Caba
Study site
La Plata, 1900
About this study
Official title: A Non-Interventional Prospective Cohort Study of Patients With Persistent Symptoms of Schizophrenia to Describe The Course and Burden of Illness
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
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of illness: Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores
Measured: from baseline to Month 24
Secondary outcomes (3)
Frequency/characteristics (PANSS) of patients with diagnosis of schizophrenia of >/= 12 months duration before baseline
Measured: 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
Measured: 24 months
Medical resource utilization/costs
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startFeb 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 1,433 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634542
- Sponsor's protocol ID
- MN28151
- Status last verified
- Nov 2016
- First submitted
- 3 Jul 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
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.
PubMed 31908462Franklin 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.
PubMed 30820841Domenech 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.
PubMed 30088146
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Prospective Cohort Study of Patients With Persistent Symptoms of Schizophrenia to Describe The Course and Burden of Illness
- ClinicalTrials.gov ID
- NCT01634542
- Acronym / sponsor ID
- MN28151
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,433 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with persistent symptoms of schizophrenia
Key inclusion criteria (6 listed)
- 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)
- Age >/= 18 years
- Family member or friend of the patient, who spends at least 4 hours a week with the patient
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Course of illness: Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores
Time frame: from baseline to Month 24
3 secondary outcomes
Frequency/characteristics (PANSS) of patients with diagnosis of schizophrenia of >/= 12 months duration before baseline
Time frame: 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
Time frame: 24 months
Medical resource utilization/costs
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 31908462Domenech 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.
- Derived from this study: PubMed 30820841Franklin 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.
- Derived from this study: PubMed 30088146Domenech 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
148 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Hoffmann-La Roche at 148 sites in 8 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 6 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 148 sites in Germany, France, Italy, Spain, United Kingdom and 3 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?
Course of illness: Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores (time frame: from baseline to Month 24). 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 NCT01634542, which also lists 3 linked publications.
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; AzTrials last refreshed its copy on 6 Nov 2026.