A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25306)

NCT01235585 | Completed Phase 3

• 2 other identifiers: WN253062010-020616-11
• Study Type: interventional
• Target: 597
• Locations: 14 countries
• Sites: 120

Brief Summary

This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally controlled 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)

• Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS)

  Change from baseline to Week 12

• Safety (incidence of adverse events)

  Week 12

Secondary Outcomes (4)

• Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS)

  Change from baseline to Week 12

• Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale

  Change from baseline to Week 12

• Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale

  Change from baseline to Week 12

• Safety (incidence of adverse events)

  60 weeks

Study Arms (3)

Bitopertin oral dose level 1

EXPERIMENTAL

Drug: bitopertin [RO4917838]

Bitopertin oral dose level 2

EXPERIMENTAL

Drug: bitopertin [RO4917838]

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Oral doses, once a day for 52 weeks

Placebo

bitopertin [RO4917838] DRUG

Oral dose level 1, once a day for 52 weeks

Bitopertin oral dose level 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, \>/= 18 years of age
• Diagnosis of schizophrenia
• Clinical stability for 16 weeks (4 months) prior to randomization
• Antipsychotic treatment stability for the past 12 weeks prior to randomization
• With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (treatment with a maximum of two antipsychotics)

You may not qualify if:

• Has treatment resistant schizophrenia as judged by the treating physician OR have failed two trials
• Evidence that patient has clinically significant uncontrolled or unstable medical disorder (e.g. cardiovascular, renal hepatic, gastrointestinal, hematologic, immunological, neurological, endocrine, metabolic or pulmonary disease)
• Patient has a body mass index (BMI) of \<17 or \>40 kg/m2, respectively)
• Diagnosis of mental retardation or severe organic brain syndromes
• In the investigator's judgment, a significant risk of suicide or violent behavior

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (120)

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Carson, California, 90746, United States

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Garden Grove, California, 92845, United States

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Long Beach, California, 90813, United States

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Long Beach, California, 90822, 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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St Louis, Missouri, 63128, United States

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St Louis, Missouri, 63141, 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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Bothell, Washington, 98011, 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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Itapira, São Paulo, 13970-905, 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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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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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, 8900000, 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, 20-045, Poland

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Lublin, 20-080, Poland

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Lublin, 20-582, 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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Trnava, 917 75, 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, 34000, Turkey (Türkiye)

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Istanbul, 34390, Turkey (Türkiye)

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Istanbul, 34736, Turkey (Türkiye)

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Kocaeli, 41380, Turkey (Türkiye)

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Manisa, 45030, Turkey (Türkiye)

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Mersin, 33169, 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, 65117, Ukraine

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Vinnytsia, 21005, Ukraine

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Related Publications (1)

• Bugarski-Kirola D, Iwata N, Sameljak S, Reid C, Blaettler T, Millar L, Marques TR, Garibaldi G, Kapur S. Efficacy and safety of adjunctive bitopertin versus placebo in patients with suboptimally controlled symptoms of schizophrenia treated with antipsychotics: results from three phase 3, randomised, double-blind, parallel-group, placebo-controlled, multicentre studies in the SearchLyte clinical trial programme. Lancet Psychiatry. 2016 Dec;3(12):1115-1128. doi: 10.1016/S2215-0366(16)30344-3. Epub 2016 Nov 2.

  PMID: 27816567 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: October 22, 2010
• First Posted: November 5, 2010
• Study Start: December 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

BR (10); CL (7); DE (8); CA (9); SL (6); TU (9); LI (7); UA (9); LA (3); PL (9); TW (7); US (25); NL (3); ES (8)