A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)

NCT01235559 | Completed Phase 3

• 2 other identifiers: WN253052010-020718-26
• Study Type: interventional
• Target: 604
• Locations: 7 countries
• Sites: 90

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)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

bitopertin [RO4917838] 1

EXPERIMENTAL

Drug: bitopertin [RO4917838] level 1

bitopertin [RO4917838] 2

EXPERIMENTAL

Drug: bitopertin [RO4917838] level 2

Interventions

Placebo DRUG

Oral doses, once a day for 52 weeks

Placebo

bitopertin [RO4917838] level 1 DRUG

Oral dose level 1, once a day for 52 weeks

bitopertin [RO4917838] 1

bitopertin [RO4917838] level 2 DRUG

Oral dose level 2, once a day for 52 weeks

bitopertin [RO4917838] 2

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 (90)

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Costa Mesa, California, 92626, United States

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Escondido, California, 92025, United States

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Granada Hills, California, 91344, United States

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La Jolla, California, 92093, United States

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Oceanside, California, 92056, United States

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San Diego, California, 92103, United States

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Torrance, California, 90502, United States

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Lauderhill, Florida, 33319, United States

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Orange City, Florida, 3273, United States

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Plantation, Florida, 33317, United States

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Atlanta, Georgia, 30308, United States

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Indianapolis, Indiana, 46222, United States

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Flowood, Mississippi, 39232, United States

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Las Vegas, Nevada, 89102, United States

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Buffalo, New York, 14215, United States

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New York, New York, 10032, United States

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Rochester, New York, 14618, United States

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Durham, North Carolina, 27705, United States

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Scranton, Pennsylvania, 18503, United States

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Austin, Texas, 78754, United States

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Irving, Texas, 75062, United States

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Salt Lake City, Utah, 84106, United States

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Burgas, 8000, Bulgaria

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Kazanlak, 6100, Bulgaria

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Novi Iskar, 1282, Bulgaria

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Pazardzhik, 4400, Bulgaria

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Plovdiv, 4002, Bulgaria

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Radnevo, 6260, Bulgaria

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Rousse, 7003, Bulgaria

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Sofia, 1606, Bulgaria

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Baoding, 071000, China

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Beijing, 071000, China

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Beijing, 100083, China

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Beijing, 100088, China

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Changsha, 410011, China

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Chengdu, 610041, China

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GuangzhouGuangdong, 510370, China

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Hangzhou, 310003, China

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Kunming, 650032, China

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Nanjing, 210029, China

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Shanghai, 200030, China

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Shanghai, 200065, China

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Wuhan, 430060, China

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Wuxi, 214151, China

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Xi'an, 710032, China

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Xi'an, 710061, China

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Brno, 602 00, Czechia

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Liberec, 460 63, Czechia

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Mělník, 276 01, Czechia

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Pilsen, 312 00, Czechia

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Prague, 100 00, Czechia

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Prague, 160 00, Czechia

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Praha 8 - Bohnice, 181 03, Czechia

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Sternberk, 785 01, Czechia

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Bari, Apulia, 70124, Italy

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Napoli, Campania, 80131, Italy

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Brescia, Lombardy, 25123, Italy

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Milan, Lombardy, 20121, Italy

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Milan, Lombardy, 20122, Italy

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Turin, Piedmont, 10126, Italy

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Pisa, Tuscany, 56124, Italy

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Pisa, Tuscany, 56126, Italy

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Padua, Veneto, 35128, Italy

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Chiba, 272-8516, Japan

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Funabashi-shi, 273-8540, Japan

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Gunma, 370-2455, Japan

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Hiroshima, 733-0864, Japan

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Hokkaido, 060-8648, Japan

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Kanzaki-gun, 842-0192, Japan

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Kita-ku, 114-0024, Japan

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Kitakyushu-shi, 807-8556, Japan

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Kochi, 780-8535, Japan

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Koshi-shi, 861-1116, Japan

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Kumamoto, 861-8002, Japan

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Kurayoshi-shi, 682-0023, Japan

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Nagoya, 463-0802, Japan

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Omuta-shi, 836-0004, Japan

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Sakaishi, 590-0018, Japan

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Sapporo, 004-0841, Japan

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Sapporo, 006-0816, Japan

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Sendai, 983-0836, Japan

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Shirakawa-shi, 961-0021, Japan

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Tokyo, 162-8666, Japan

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Tokyo, 187-8551, Japan

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Toyama, 939-8073, Japan

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Toyoake-shi, 470-1192, Japan

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Yokohama, 223-0062, Japan

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Yokohama, 233-0006, Japan

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Yokohama, 246-0026, Japan

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Saint Petersburg, 190121, Russia

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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: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

RU (1); US (22); CN (16); CZ (8); BU (8); JP (26); IT (9)