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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01235520




Registration number
NCT01235520
Ethics application status
Date submitted
22/10/2010
Date registered
5/11/2010
Date last updated
2/06/2015

Titles & IDs
Public title
A Study of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (NN25307)
Scientific 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.
Secondary ID [1] 0 0
2010-020696-23
Secondary ID [2] 0 0
NN25307
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - RO4917838
Treatment: Drugs - RO4917838

Experimental: 1 -

Experimental: 2 -

Placebo comparator: 3 -


Treatment: Drugs: Placebo
Oral doses, once a day for 52 weeks

Treatment: Drugs: RO4917838
Oral dose level 1, once a day for 52 weeks

Treatment: Drugs: RO4917838
Oral dose level 2, once a day for 52 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS)
Timepoint [1] 0 0
Change from baseline to Week 12
Primary outcome [2] 0 0
Safety (incidence of adverse events)
Timepoint [2] 0 0
Week 12
Secondary outcome [1] 0 0
Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS)
Timepoint [1] 0 0
Change from baseline to Week 12
Secondary outcome [2] 0 0
Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale
Timepoint [2] 0 0
Change from baseline to Week 12
Secondary outcome [3] 0 0
Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale
Timepoint [3] 0 0
Change from baseline to Week 12
Secondary outcome [4] 0 0
Safety (incidence of adverse events)
Timepoint [4] 0 0
60 weeks

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
595
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Westmead
Recruitment hospital [2] 0 0
- Clayton
Recruitment hospital [3] 0 0
- Frankston
Recruitment hospital [4] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
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United States of America
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Arkansas
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California
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Illinois
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Iowa
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Maryland
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Pennsylvania
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Texas
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Washington
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma Bs As
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Argentina
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Ciudad de Mendoza
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Argentina
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Cordoba
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Argentina
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La Plata
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Mendoza
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Argentina
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Rosario
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Santiago del Estero
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Colombia
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Barranquilla
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Bello
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Bogota
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Budapest
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Gyor
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Gyula
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Jaipur
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Nashik
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Incheon
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Arad
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Bucuresti
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Cluj-Napoca
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Lasi
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Oradea
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Sibiu
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Romania
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Targouiste
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Russian Federation
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Kemerovo
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Lipetsk
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Moscow Region
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Moscow
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Russian Federation
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Nizhny Novgorod
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Saint Petersburg
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Samara
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Sartatov
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St Petersbourg
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St Petersburg
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St. Petersburg
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Talagi
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Russian Federation
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Tomsk
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Sweden
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Malmö
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Sweden
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Stockholm
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Sweden
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Uppsala
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United Kingdom
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Edinburgh
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London
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United Kingdom
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01235520
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01235520