A Study of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (NN25307)

NCT01235520 | Completed Phase 3

• 2 other identifiers: NN253072010-020696-23
• Study Type: interventional
• Target: 595
• Locations: 14 countries
• Sites: 121

Brief Summary

This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 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)

1

EXPERIMENTAL

Drug: RO4917838

2

EXPERIMENTAL

Drug: RO4917838

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Oral doses, once a day for 52 weeks

3

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, \>/= 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 (121)

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Little Rock, Arkansas, 72201, United States

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Little Rock, Arkansas, 72211, United States

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Buena Park, California, 90620, United States

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Cerritos, California, 90703, United States

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Downey, California, 90241, United States

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La Palma, California, 90623, United States

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Pasadena, California, 91106, United States

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Pico Rivera, California, 90660, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33136, United States

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Marietta, Georgia, 30060, United States

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Oak Brook, Illinois, 60523, United States

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Iowa City, Iowa, 52242, United States

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Glen Burnie, Maryland, 21061, United States

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Las Vegas, Nevada, 89102, United States

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Toms River, New Jersey, 08775, United States

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Willingboro, New Jersey, 08046, United States

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Albuquerque, New Mexico, 87108, United States

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Brooklyn, New York, 11201, United States

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Fresh Meadows, New York, 11366, United States

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New York, New York, 10035, United States

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Raleigh, North Carolina, 27603, United States

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Cincinnati, Ohio, 45206, United States

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Philadelphia, Pennsylvania, 19131, United States

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Scranton, Pennsylvania, 18503, United States

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Bellaire, Texas, 77401, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75243, United States

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The Woodlands, Texas, 77381, United States

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Kirkland, Washington, 98033, United States

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Buenos Aires, 1425, Argentina

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Buenos Aires, C1425AHQ, Argentina

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Ciudad Autonoma Bs As, 1117, Argentina

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Ciudad Autonoma Bs As, 1405, Argentina

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Córdoba, 5003, Argentina

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Córdoba, X5009BIN, Argentina

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La Plata, 1900, Argentina

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Mendoza, 5500, Argentina

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Rosario, S2000QJI, Argentina

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Santiago del Estero, 4200, Argentina

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Westmead, New South Wales, 2145, Australia

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Clayton, Victoria, 3168, Australia

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Frankston, Victoria, 3199, Australia

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Melbourne, Victoria, 3004, Australia

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Barranquilla, Colombia

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Bello, Colombia

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Bogotá, Colombia

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Helsinki, 00250, Finland

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Kuopio, 70100, Finland

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Clermont-Ferrand, 63000, France

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Dole, 39100, France

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Élancourt, 78990, France

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Marseille, 13005, France

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Strasbourg, 67091, France

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Toulon, 83000, France

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Balassagyarmat, 2660, Hungary

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Budapest, 1032, Hungary

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Budapest, 1082, Hungary

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Budapest, 1135, Hungary

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Győr, 9024, Hungary

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Gyula, 5700, Hungary

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Ahmedabad, 380006, India

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Ahmedabad, 380008, India

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Ahmedabad, 380015, India

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Bangalore, 560054, India

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Jaipur, 302017, India

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Jaipur, 302021, India

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Kalyān, 421301, India

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Mangalore, 575001, India

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Mangalore, 575018, India

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Nashik, 422101, India

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Pune, 411030, India

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Vadodara, 390001, India

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México, 05300, Mexico

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Monterrey, 64000, Mexico

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Monterrey, 64060, Mexico

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Monterrey, 64710, Mexico

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San Luis Potosí City, 72818, Mexico

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Arad, 310022, Romania

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Bucharest, 010825, Romania

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Bucharest, 041914, Romania

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Cluj-Napoca, 400012, Romania

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Lasi, 700282, Romania

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Oradea, 410154, Romania

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Sibiu, 550082, Romania

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Targouiste, 130081, Romania

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Kemerovo, 650036, Russia

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Lipetsk, 399313, Russia

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Moscow, 107076, Russia

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Moscow, 115522, Russia

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Moscow, 117995, Russia

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Moscow, 127083, Russia

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Moscow Region, 142601, Russia

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Nizhny Novgorod, 603155, Russia

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Saint Petersburg, 190005, Russia

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Saint Petersburg, 190121, Russia

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Saint Petersburg, 192019, Russia

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Saint Petersburg, 193167, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 197341, Russia

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Samara, 443016, Russia

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Sartatov, 410028, Russia

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Talagi, 163530, Russia

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Tomsk, 634014, Russia

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Busan, 614-735, South Korea

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Gwangju, 501-757, South Korea

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Gyeonggi-do, 425-707, South Korea

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Incheon, 400-711, South Korea

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Incheon, 405-760, South Korea

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Jeollabuk-do, 561-712, South Korea

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Seoul, 110-774, South Korea

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Seoul, 136-705, South Korea

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Seoul, 150-713, South Korea

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Malmo, 21135, Sweden

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Stockholm, 14186, Sweden

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Stockholm, 18288, Sweden

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Uppsala, 75185, Sweden

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Edinburgh, EH10 5HF, United Kingdom

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London, SE5-8AF, United Kingdom

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London, W12 0HS, United Kingdom

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Oxford, OX3 7JX, United Kingdom

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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

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: January 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 2, 2015

Record last verified: 2015-06

Locations

SE (4); GB (4); US (30); AR (10); CO (3); ME (5); RO (8); IN (12); FR (6); AU (4); HU (6); FI (2); KR (9); RU (18)