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

NCT01192906 | Completed Phase 3

• 2 other identifiers: WN253092010-020467-21
• Study Type: interventional
• Target: 624
• Locations: 14 countries
• Sites: 113

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• Efficacy (PANSS negative symptoms factor score)

  Week 24

• Safety (incidence of adverse events)

  Week 24

Study Arms (3)

1

EXPERIMENTAL

Drug: bitopertin [RO4917838]

2

EXPERIMENTAL

Drug: bitopertin [RO4917838]

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Oral doses, once a day for 52 weeks

3

bitopertin [RO4917838] DRUG

Oral dose level 1, once a day for 52 weeks

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (113)

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Carson, California, 90746, United States

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Oceanside, California, 92056, United States

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San Diego, California, 92121, United States

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San Diego, California, 92123, United States

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Hartford, Connecticut, 06106, United States

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Norwalk, Connecticut, 06851, United States

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North Miami, Florida, 33161, United States

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Atlanta, Georgia, 30328, United States

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Chicago, Illinois, 60612, United States

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Hoffman Estates, Illinois, 60169, United States

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Joliet, Illinois, 60435, United States

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Lake Charles, Louisiana, 70601, United States

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Shreveport, Louisiana, 71104-2136, United States

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St Louis, Missouri, 63128, United States

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Omahac, Nebraska, 68131, United States

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Cedarhurst, New York, 11516, United States

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Jamaica, New York, 11418, United States

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Rochester, New York, 14623, United States

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Allentown, Pennsylvania, 18104, United States

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Norristown, Pennsylvania, 19403, United States

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Philadelphia, Pennsylvania, 19139, United States

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Salvador, Estado de Bahia, 40301-500, Brazil

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Goiânia, Goiás, 74093-040, Brazil

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Belo Horizonte, Minas Gerais, 30150-270, Brazil

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Curitiba, Paraná, 80240-280, Brazil

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Rio de Janeiro, Rio de Janeiro, 22270-060, Brazil

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Pelotas, Rio Grande do Sul, 96030-002, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

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São Paulo, São Paulo, 04044-000, Brazil

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São Paulo, São Paulo, 05403-010, Brazil

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Calgary, Alberta, T2N 4Z6, Canada

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Medicine Hat, Alberta, T1B 4E7, Canada

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Vancouver, British Columbia, V5Z 3P1, Canada

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Victoria, British Columbia, V8R 4Z3, Canada

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Halifax, Nova Scotia, B3H 2E2, Canada

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Burlington, Ontario, L7R 4E2, Canada

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Hamilton, Ontario, L8N 3K7, Canada

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Mississauga, Ontario, L5M 4N4, Canada

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Montreal, Quebec, H1N 3M5, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Verdun, Quebec, H4H 1R3, Canada

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San Miguel, 8900000, Chile

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Santiago, 7500710, Chile

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Santiago, 7501126, Chile

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Santiago, 8050000, Chile

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Santiago, 8320000, Chile

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Santiago, Chile

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Valdivia, 5090000, Chile

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Berlin, 10117, Germany

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Bochum, 44805, Germany

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Cologne, 50937, Germany

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Freiburg im Breisgau, 79104, Germany

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Hamburg, 20246, Germany

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München, 80336, Germany

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München, 81675, Germany

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Nuremberg, 90402, Germany

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Daugovpils, LV-5417, Latvia

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Jelgava, LV-3008, Latvia

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Liepāja, LV 3401, Latvia

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Kaunas, 44279, Lithuania

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Kaunas, 48259, Lithuania

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Kaunas, 50009, Lithuania

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Kaunas, 53136, Lithuania

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Šilutė, 99142, Lithuania

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Vilnius, 07156, Lithuania

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Vilnius, 10204, Lithuania

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Assen, 9400 RA, Netherlands

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Groningen, 9700 AB, Netherlands

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Groningen, 9713 GZ, Netherlands

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Choroszcz, 16-070, Poland

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Kielce, 25-103, Poland

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Lublin, 20-015, Poland

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Lublin, 20-045, Poland

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Lublin, 20-080, Poland

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Piekary Śląskie, 41-940, Poland

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Skorzewo, 60-185, Poland

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Tuszyn, 95-080, Poland

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Warsaw, 02-957, Poland

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Bojnice, 972 01, Slovakia

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Bratislava, 820 07, Slovakia

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Bratislava, 851 01, Slovakia

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Rimavská Sobota, 97912, Slovakia

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Svidník, 089 01, Slovakia

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Barcelona, Barcelona, 08036, Spain

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Barcelona, Barcelona, 08304, Spain

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Barcelona, Barcelona, 08830, Spain

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Madrid, Madrid, 28009, Spain

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Madrid, Madrid, 28040, Spain

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Oviedo, Principality of Asturias, 33011, Spain

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Salamanca, Salamanca, 37007, Spain

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Zamora, Zamora, 49021, Spain

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Hualian Town, 970, Taiwan

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Kaohsiung City, 80276, Taiwan

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Taichung, 407, Taiwan

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Tainan, 704, Taiwan

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Tainan County, 717, Taiwan

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Taipei, 00112, Taiwan

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Taipei, 110, Taiwan

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Ankara, 06100, Turkey (Türkiye)

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Diyarbakır, 21280, Turkey (Türkiye)

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Gaziantep, 27310, Turkey (Türkiye)

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Istanbul, 34390, Turkey (Türkiye)

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Istanbul, 34736, Turkey (Türkiye)

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Manisa, 45010, Turkey (Türkiye)

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Dnipropetrovsk, 49005, Ukraine

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Donetsk, 83008, Ukraine

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Glevakha Kyviv Region, 08631, Ukraine

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Kharkiv, 61068, Ukraine

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Kyiv, 02660, Ukraine

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Kyiv, 04080, Ukraine

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Lviv, 79021, Ukraine

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Odesa, 65006, Ukraine

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Vinnytsia, 21005, Ukraine

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Related Publications (2)

• 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.

  PMID: 28433500 DERIVED

• 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.

  PMID: 28117049 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

(4-(3-fluoro-5-trifluoromethylpyridin-2-yl)piperazin-1-yl)(5-methanesulfonyl-2-(2,2,2-trifluoro-1-methylethoxy)phenyl)methanone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: September 1, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

LI (7); ES (8); TU (6); DE (8); LA (3); CL (7); SL (5); CA (11); UA (9); BR (9); US (21); NL (3); TW (7); PL (9)