Clinical trial NCT01235585: A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25306)
Official title: Phase III, Multi-center, Randomized, 12-week, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 40-week Double-blind, Parallel-group, Placebo-controlled Treatment Period.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-11-05
Enrollment: 597
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS)
timeFrame: Change from baseline to Week 12
measure: Safety (incidence of adverse events)
timeFrame: Week 12
Secondary outcomes:
measure: Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS)
timeFrame: Change from baseline to Week 12
measure: Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale
timeFrame: Change from baseline to Week 12
measure: Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale
timeFrame: Change from baseline to Week 12
measure: Safety (incidence of adverse events)
timeFrame: 60 weeks
Other outcomes:
Locations:
city: Carson
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Oceanside
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Hartford
country: United States
state: Connecticut
city: Norwalk
country: United States
state: Connecticut
city: North Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Hoffman Estates
country: United States
state: Illinois
city: Joliet
country: United States
state: Illinois
city: Lake Charles
country: United States
state: Louisiana
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Omahac
country: United States
state: Nebraska
city: Cedarhurst
country: United States
state: New York
city: Jamaica
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Allentown
country: United States
state: Pennsylvania
city: Norristown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Bothell
country: United States
state: Washington
city: Salvador
country: Brazil
state: BA
city: Goiania
country: Brazil
state: GO
city: Belo Horizonte
country: Brazil
state: MG
city: Curitiba
country: Brazil
state: PR
city: Rio de Janeiro
country: Brazil
state: RJ
city: Pelotas
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Itapira
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Calgary
country: Canada
state: Alberta
city: Medicine Hat
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Halifax
country: Canada
state: Nova Scotia
city: Burlington
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Valdivia
country: Chile
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Freiburg
country: Germany
city: Hamburg
country: Germany
city: Koeln
country: Germany
city: Muenchen
country: Germany
city: Muenchen
country: Germany
city: Nürnberg
country: Germany
city: Daugovpils
country: Latvia
city: Jelgava
country: Latvia
city: Liepaja
country: Latvia
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Silute
country: Lithuania
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
city: Assen
country: Netherlands
city: Groningen
country: Netherlands
city: Groningen
country: Netherlands
city: Choroszcz
country: Poland
city: Kielce
country: Poland
city: Lublin
country: Poland
city: Lublin
country: Poland
city: Lublin
country: Poland
city: Piekary Slaskie
country: Poland
city: Skorzewo
country: Poland
city: Tuszyn
country: Poland
city: Warszawa
country: Poland
city: Bojnice
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Rimavska Sobota
country: Slovakia
city: Svidnik
country: Slovakia
city: Trnava
country: Slovakia
city: Oviedo
country: Spain
state: Asturias
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Salamanca
country: Spain
city: Zamora
country: Spain
city: Hualian Town
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan County
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Ankara
country: Turkey
city: Diyarbakir
country: Turkey
city: Gaziantep
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Kocaeli
country: Turkey
city: Manisa
country: Turkey
city: Mersin
country: Turkey
city: Dnipropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Glevakha Kyviv region
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Odesa
country: Ukraine
city: Vinnytsya
country: Ukraine
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.