A Study of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (NN25307)
NCT ID: NCT01235520
Last Updated: 2015-06-02
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
595 participants
INTERVENTIONAL
2011-01-31
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
RO4917838
Oral dose level 1, once a day for 52 weeks
2
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
RO4917838
Oral dose level 1, once a day for 52 weeks
RO4917838
Oral dose level 2, once a day for 52 weeks
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
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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Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
Buena Park, California, United States
Cerritos, California, United States
Downey, California, United States
La Palma, California, United States
Pasadena, California, United States
Pico Rivera, California, United States
Miami, Florida, United States
Miami, Florida, United States
Marietta, Georgia, United States
Oak Brook, Illinois, United States
Iowa City, Iowa, United States
Glen Burnie, Maryland, United States
Las Vegas, Nevada, United States
Toms River, New Jersey, United States
Willingboro, New Jersey, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
Fresh Meadows, New York, United States
New York, New York, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Scranton, Pennsylvania, United States
Bellaire, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
The Woodlands, Texas, United States
Kirkland, Washington, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Ciudad Autonoma Bs As, , Argentina
Ciudad Autonoma Bs As, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
La Plata, , Argentina
Mendoza, , Argentina
Rosario, , Argentina
Santiago del Estero, , Argentina
Westmead, New South Wales, Australia
Clayton, Victoria, Australia
Frankston, Victoria, Australia
Melbourne, Victoria, Australia
Barranquilla, , Colombia
Bello, , Colombia
Bogotá, , Colombia
Helsinki, , Finland
Kuopio, , Finland
Clermont-Ferrand, , France
Dole, , France
Élancourt, , France
Marseille, , France
Strasbourg, , France
Toulon, , France
Balassagyarmat, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Győr, , Hungary
Gyula, , Hungary
Ahmedabad, , India
Ahmedabad, , India
Ahmedabad, , India
Bangalore, , India
Jaipur, , India
Jaipur, , India
Kalyān, , India
Mangalore, , India
Mangalore, , India
Nashik, , India
Pune, , India
Vadodara, , India
México, , Mexico
Monterrey, , Mexico
Monterrey, , Mexico
Monterrey, , Mexico
San Luis Potosí City, , Mexico
Arad, , Romania
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Lasi, , Romania
Oradea, , Romania
Sibiu, , Romania
Targouiste, , Romania
Kemerovo, , Russia
Lipetsk, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow Region, , Russia
Nizhny Novgorod, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Sartatov, , Russia
Talagi, , Russia
Tomsk, , Russia
Busan, , South Korea
Gwangju, , South Korea
Gyeonggi-do, , South Korea
Incheon, , South Korea
Incheon, , South Korea
Jeollabuk-do, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Malmo, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
Edinburgh, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Oxford, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2010-020696-23
Identifier Type: -
Identifier Source: secondary_id
NN25307
Identifier Type: -
Identifier Source: org_study_id
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