A Study of RO4917838 (Bitopertin) in Patients With Persistent, Predominant Negative Symptoms of Schizophrenia (WN25309)
NCT ID: NCT01192906
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
624 participants
INTERVENTIONAL
2010-12-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
bitopertin [RO4917838]
Oral dose level 1, once a day for 52 weeks
2
bitopertin [RO4917838]
Oral dose level 2, once a day for 52 weeks
3
Placebo
Oral doses, once a day for 52 weeks
Interventions
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Placebo
Oral doses, once a day for 52 weeks
bitopertin [RO4917838]
Oral dose level 1, once a day for 52 weeks
bitopertin [RO4917838]
Oral dose level 2, once a day for 52 weeks
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Carson, California, United States
Oceanside, California, United States
San Diego, California, United States
San Diego, California, United States
Hartford, Connecticut, United States
Norwalk, Connecticut, United States
North Miami, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Hoffman Estates, Illinois, United States
Joliet, Illinois, United States
Lake Charles, Louisiana, United States
Shreveport, Louisiana, United States
St Louis, Missouri, United States
Omahac, Nebraska, United States
Cedarhurst, New York, United States
Jamaica, New York, United States
Rochester, New York, United States
Allentown, Pennsylvania, United States
Norristown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Salvador, Estado de Bahia, Brazil
Goiânia, Goiás, Brazil
Belo Horizonte, Minas Gerais, Brazil
Curitiba, Paraná, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
Pelotas, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Calgary, Alberta, Canada
Medicine Hat, Alberta, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Halifax, Nova Scotia, Canada
Burlington, Ontario, Canada
Hamilton, Ontario, Canada
Mississauga, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Verdun, Quebec, Canada
San Miguel, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Valdivia, , Chile
Berlin, , Germany
Bochum, , Germany
Cologne, , Germany
Freiburg im Breisgau, , Germany
Hamburg, , Germany
München, , Germany
München, , Germany
Nuremberg, , Germany
Daugovpils, , Latvia
Jelgava, , Latvia
Liepāja, , Latvia
Kaunas, , Lithuania
Kaunas, , Lithuania
Kaunas, , Lithuania
Kaunas, , Lithuania
Šilutė, , Lithuania
Vilnius, , Lithuania
Vilnius, , Lithuania
Assen, , Netherlands
Groningen, , Netherlands
Groningen, , Netherlands
Choroszcz, , Poland
Kielce, , Poland
Lublin, , Poland
Lublin, , Poland
Lublin, , Poland
Piekary Śląskie, , Poland
Skorzewo, , Poland
Tuszyn, , Poland
Warsaw, , Poland
Bojnice, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Rimavská Sobota, , Slovakia
Svidník, , Slovakia
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Oviedo, Principality of Asturias, Spain
Salamanca, Salamanca, Spain
Zamora, Zamora, Spain
Hualian Town, , Taiwan
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Tainan City, , Taiwan
Tainan County, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Ankara, , Turkey (Türkiye)
Diyarbakır, , Turkey (Türkiye)
Gaziantep, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Manisa, , Turkey (Türkiye)
Dnipropetrovsk, , Ukraine
Donetsk, , Ukraine
Glevakha Kyviv Region, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Vinnytsia, , Ukraine
Countries
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References
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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.
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.
Other Identifiers
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2010-020467-21
Identifier Type: -
Identifier Source: secondary_id
WN25309
Identifier Type: -
Identifier Source: org_study_id