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SchizophreniaPhase 3NCT01192906

A Study of RO4917838 (Bitopertin) in Patients With Persistent, Predominant Negative Symptoms of Schizophrenia (WN25309)

A Phase 3 study testing bitopertin [RO4917838] in people with Schizophrenia, run by Hoffmann-La Roche at 113 sites in 14 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 multi-center, randomized, double blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with persistent, predominant negative symptoms of schizophrenia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia
What is being tested?
bitopertin [RO4917838]
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
624 participants
Where
113 sitesin 14 countries
Study dates
Dec 2010to Jul 2014
Phase
Phase 3
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

Who may be able to join

  • Adult patients, aged 18 years and above
  • Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype
  • Predominant negative symptoms
  • With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics)

Who cannot join

  • Evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
  • Body Mass Index (BMI) of <17 or >40 kg/m2
  • Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS)
  • A severity score of 3 or greater on the Parkinsonism item of the ESRS-A (Clinical Global Impression, Parkinsonism)

Trial locations and contacts

113 sites in 14 countries.

113 sites in 14 countries

United States21 sites

  • Study site

    Allentown, Pennsylvania, 18104

  • Study site

    Atlanta, Georgia, 30328

  • Study site

    Carson, California, 90746

  • Study site

    Cedarhurst, New York, 11516

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Hartford, Connecticut, 06106

  • Study site

    Hoffman Estates, Illinois, 60169

  • Study site

    Jamaica, New York, 11418

  • Study site

    Joliet, Illinois, 60435

  • Study site

    Lake Charles, Louisiana, 70601

  • Study site

    Norristown, Pennsylvania, 19403

  • Study site

    North Miami, Florida, 33161

  • Study site

    Norwalk, Connecticut, 06851

  • Study site

    Oceanside, California, 92056

  • Study site

    Omahac, Nebraska, 68131

  • Study site

    Philadelphia, Pennsylvania, 19139

  • Study site

    Rochester, New York, 14623

  • Study site

    San Diego, California, 92121

  • Study site

    San Diego, California, 92123

  • Study site

    Shreveport, Louisiana, 71104-2136

  • Study site

    St Louis, Missouri, 63128

Other trials in United States

Canada11 sites

  • Study site

    Burlington, Ontario, L7R 4E2

  • Study site

    Calgary, Alberta, T2N 4Z6

  • Study site

    Halifax, Nova Scotia, B3H 2E2

  • Study site

    Hamilton, Ontario, L8N 3K7

  • Study site

    Medicine Hat, Alberta, T1B 4E7

  • Study site

    Mississauga, Ontario, L5M 4N4

  • Study site

    Montreal, Quebec, H1N 3M5

  • Study site

    Montreal, Quebec, H3A 1A1

  • Study site

    Vancouver, British Columbia, V5Z 3P1

  • Study site

    Verdun, Quebec, H4H 1R3

  • Study site

    Victoria, British Columbia, V8R 4Z3

Other trials in Canada

Brazil9 sites

  • Study site

    Belo Horizonte, Minas Gerais, 30150-270

  • Study site

    Curitiba, Paraná, 80240-280

  • Study site

    Goiânia, Goiás, 74093-040

  • Study site

    Pelotas, Rio Grande do Sul, 96030-002

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Study site

    Rio de Janeiro, Rio de Janeiro, 22270-060

  • Study site

    Salvador, Estado de Bahia, 40301-500

  • Study site

    São Paulo, São Paulo, 04044-000

  • Study site

    São Paulo, São Paulo, 05403-010

Other trials in Brazil

Poland9 sites

  • Study site

    Choroszcz, 16-070

  • Study site

    Kielce, 25-103

  • Study site

    Lublin, 20-015

  • Study site

    Lublin, 20-045

  • Study site

    Lublin, 20-080

  • Study site

    Piekary Śląskie, 41-940

  • Study site

    Skorzewo, 60-185

  • Study site

    Tuszyn, 95-080

  • Study site

    Warsaw, 02-957

Other trials in Poland

Ukraine9 sites

  • Study site

    Dnipropetrovsk, 49005

  • Study site

    Donetsk, 83008

  • Study site

    Glevakha Kyviv Region, 08631

  • Study site

    Kharkiv, 61068

  • Study site

    Kyiv, 02660

  • Study site

    Kyiv, 04080

  • Study site

    Lviv, 79021

  • Study site

    Odesa, 65006

  • Study site

    Vinnytsia, 21005

Other trials in Ukraine

Germany8 sites

  • Study site

    Berlin, 10117

  • Study site

    Bochum, 44805

  • Study site

    Cologne, 50937

  • Study site

    Freiburg im Breisgau, 79104

  • Study site

    Hamburg, 20246

  • Study site

    München, 80336

  • Study site

    München, 81675

  • Study site

    Nuremberg, 90402

Other trials in Germany

Spain8 sites

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Barcelona, Barcelona, 08304

  • Study site

    Barcelona, Barcelona, 08830

  • Study site

    Madrid, Madrid, 28009

  • Study site

    Madrid, Madrid, 28040

  • Study site

    Oviedo, Principality of Asturias, 33011

  • Study site

    Salamanca, Salamanca, 37007

  • Study site

    Zamora, Zamora, 49021

Other trials in Spain

Chile7 sites

  • Study site

    San Miguel, 8900000

  • Study site

    Santiago, 7500710

  • Study site

    Santiago, 7501126

  • Study site

    Santiago, 8050000

  • Study site

    Santiago, 8320000

  • Study site

    Santiago

  • Study site

    Valdivia, 5090000

Other trials in Chile

Lithuania7 sites

  • Study site

    Kaunas, 44279

  • Study site

    Kaunas, 48259

  • Study site

    Kaunas, 50009

  • Study site

    Kaunas, 53136

  • Study site

    Šilutė, 99142

  • Study site

    Vilnius, 07156

  • Study site

    Vilnius, 10204

Other trials in Lithuania

Taiwan7 sites

  • Study site

    Hualian Town, 970

  • Study site

    Kaohsiung City, 80276

  • Study site

    Taichung, 407

  • Study site

    Tainan, 704

  • Study site

    Tainan County, 717

  • Study site

    Taipei, 00112

  • Study site

    Taipei, 110

Other trials in Taiwan

Turkey (Türkiye)6 sites

  • Study site

    Ankara, 06100

  • Study site

    Diyarbakır, 21280

  • Study site

    Gaziantep, 27310

  • Study site

    Istanbul, 34390

  • Study site

    Istanbul, 34736

  • Study site

    Manisa, 45010

Other trials in Turkey (Türkiye)

Slovakia5 sites

  • Study site

    Bojnice, 972 01

  • Study site

    Bratislava, 820 07

  • Study site

    Bratislava, 851 01

  • Study site

    Rimavská Sobota, 97912

  • Study site

    Svidník, 089 01

Other trials in Slovakia

Latvia3 sites

  • Study site

    Daugovpils, LV-5417

  • Study site

    Jelgava, LV-3008

  • Study site

    Liepāja, LV 3401

Other trials in Latvia

Netherlands3 sites

  • Study site

    Assen, 9400 RA

  • Study site

    Groningen, 9700 AB

  • Study site

    Groningen, 9713 GZ

Other trials in Netherlands

About this study

Official title: A Phase III, Multi-center, Randomized, 24 Week, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate Efficacy and Safety of RO4917838 in Stable Patients With Persistent, Predominant Negative Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 28 Week, Double-blind Treatment Period.

This multi-center, randomized, double blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with persistent, predominant negative symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.

Conditions
Schizophrenia
Being tested
Placebo, bitopertin [RO4917838]
Medical subject headings
Schizophrenia

What participants receive

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

  • PlaceboDrug

    Oral doses, once a day for 52 weeks

  • bitopertin [RO4917838]Drug

    Oral dose level 1, once a day for 52 weeks

  • bitopertin [RO4917838]Drug

    Oral dose level 2, once a day for 52 weeks

Study groups in NCT01192906
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: bitopertin [RO4917838]
2ExperimentalNot described
Receives: Drug: bitopertin [RO4917838]
3Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Efficacy (PANSS negative symptoms factor score)

    Measured: Week 24

  2. Safety (incidence of adverse events)

    Measured: Week 24

Timeline

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

  1. First posted1 Sep 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
624 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01192906
Sponsor's protocol ID
WN25309
Other IDs
2010-020467-21
Status last verified
Nov 2016
First submitted
30 Aug 2010
Last updated
2 Nov 2016
Results posted
No

Publications

  • Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.

    PubMed 28433500

  • Bugarski-Kirola D, Blaettler T, Arango C, Fleischhacker WW, Garibaldi G, Wang A, Dixon M, Bressan RA, Nasrallah H, Lawrie S, Napieralski J, Ochi-Lohmann T, Reid C, Marder SR. Bitopertin in Negative Symptoms of Schizophrenia-Results From the Phase III FlashLyte and DayLyte Studies. Biol Psychiatry. 2017 Jul 1;82(1):8-16. doi: 10.1016/j.biopsych.2016.11.014. Epub 2016 Dec 15.

    PubMed 28117049

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bitopertin [RO4917838] in people with Schizophrenia, run by Hoffmann-La Roche at 113 sites in 14 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 4 inclusion and 4 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 113 sites in United States, Canada, Brazil, Poland, Ukraine and 9 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Efficacy (PANSS negative symptoms factor score) (time frame: Week 24). The study lists 2 primary outcomes in all. 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 NCT01192906, which also lists 2 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.

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