Clinical trial NCT01235520: A Study of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (NN25307)
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: 595
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 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: Little Rock
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Buena Park
country: United States
state: California
city: Cerritos
country: United States
state: California
city: Downey
country: United States
state: California
city: La Palma
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Pico Rivera
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Oak Brook
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Glen Burnie
country: United States
state: Maryland
city: Las Vegas
country: United States
state: Nevada
city: Toms River
country: United States
state: New Jersey
city: Willingboro
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Brooklyn
country: United States
state: New York
city: Fresh Meadows
country: United States
state: New York
city: New York
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Scranton
country: United States
state: Pennsylvania
city: Bellaire
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: The Woodlands
country: United States
state: Texas
city: Kirkland
country: United States
state: Washington
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Ciudad Autonoma Bs As
country: Argentina
city: Ciudad Autonoma Bs As
country: Argentina
city: Ciudad de Mendoza
country: Argentina
city: Cordoba
country: Argentina
city: Cordoba
country: Argentina
city: La Plata
country: Argentina
city: Mendoza
country: Argentina
city: Rosario
country: Argentina
city: Santiago del Estero
country: Argentina
city: Westmead
country: Australia
state: New South Wales
city: Clayton
country: Australia
state: Victoria
city: Frankston
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Barranquilla
country: Colombia
city: Bello
country: Colombia
city: Bogota
country: Colombia
city: Helsinki
country: Finland
city: Kuopio
country: Finland
city: Clermont-ferrand
country: France
city: Dole
country: France
city: Elancourt
country: France
city: Marseille
country: France
city: Strasbourg
country: France
city: Toulon
country: France
city: Balassagyarmat
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Ahmedabad
country: India
city: Ahmedabad
country: India
city: Ahmedabad
country: India
city: Bangalore
country: India
city: Jaipur
country: India
city: Jaipur
country: India
city: Kalyan
country: India
city: Mangalore
country: India
city: Mangalore
country: India
city: Nashik
country: India
city: Pune
country: India
city: Vadodara
country: India
city: Busan
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Jeollabuk-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Mexico
country: Mexico
city: Monterrey
country: Mexico
city: Monterrey
country: Mexico
city: Monterrey
country: Mexico
city: San Luis Potosi
country: Mexico
city: Arad
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Cluj-Napoca
country: Romania
city: Lasi
country: Romania
city: Oradea
country: Romania
city: Sibiu
country: Romania
city: Targouiste
country: Romania
city: Kemerovo
country: Russian Federation
city: Lipetsk
country: Russian Federation
city: Moscow Region
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Samara
country: Russian Federation
city: Sartatov
country: Russian Federation
city: St Petersbourg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Talagi
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Malmö
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
city: Edinburgh
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Oxford
country: United Kingdom
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.