Clinical trial NCT01235559: A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)
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: 604
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: Costa Mesa
country: United States
state: California
city: Escondido
country: United States
state: California
city: Granada Hills
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Oceanside
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Lauderhill
country: United States
state: Florida
city: Orange City
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Flowood
country: United States
state: Mississippi
city: Las Vegas
country: United States
state: Nevada
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Scranton
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Bourgas
country: Bulgaria
city: Kazanlak
country: Bulgaria
city: Novi Iskar
country: Bulgaria
city: Pazardzhik
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Radnevo
country: Bulgaria
city: Rousse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Baoding
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Changsha
country: China
city: Chengdu
country: China
city: GuangzhouGuangdong
country: China
city: Hangzhou
country: China
city: Kunming
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Wuhan
country: China
city: Wuxi
country: China
city: Xi'an
country: China
city: Xi'an
country: China
city: Brno
country: Czech Republic
city: Liberec
country: Czech Republic
city: Melnik
country: Czech Republic
city: Plzen
country: Czech Republic
city: Praha 10
country: Czech Republic
city: Praha 6
country: Czech Republic
city: Praha 8 - Bohnice
country: Czech Republic
city: Sternberk
country: Czech Republic
city: Napoli
country: Italy
state: Campania
city: Brescia
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Torino
country: Italy
state: Piemonte
city: Bari
country: Italy
state: Puglia
city: Pisa
country: Italy
state: Toscana
city: Pisa
country: Italy
state: Toscana
city: Padova
country: Italy
state: Veneto
city: Chiba
country: Japan
city: Funabashi-shi
country: Japan
city: Gunma
country: Japan
city: Hiroshima-shi
country: Japan
city: Hokkaido
country: Japan
city: Kanzaki-gun
country: Japan
city: Kita-Ku
country: Japan
city: Kitakyushu-shi
country: Japan
city: Kochi-shi
country: Japan
city: Koshi-shi
country: Japan
city: Kumamoto-shi
country: Japan
city: Kurayoshi-shi
country: Japan
city: Nagoya-Shi
country: Japan
city: Omuta-shi
country: Japan
city: Sakai-shi
country: Japan
city: Sapporo-shi
country: Japan
city: Sapporo-shi
country: Japan
city: Sendai-shi
country: Japan
city: Shirakawa-shi
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Toyama-shi
country: Japan
city: Toyoake-shi
country: Japan
city: Yokohama-shi
country: Japan
city: Yokohama-shi
country: Japan
city: Yokohama-shi
country: Japan
city: St. Petersburg
country: Russian Federation
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.