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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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
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California
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Florida
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Georgia
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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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United States of America
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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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Argentina
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Mendoza
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Argentina
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Rosario
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Argentina
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Santiago del Estero
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Colombia
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Barranquilla
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Colombia
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Bello
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Colombia
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Bogota
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Finland
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Helsinki
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Finland
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Kuopio
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France
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Clermont-ferrand
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France
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Dole
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France
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Elancourt
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France
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Marseille
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Strasbourg
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France
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Toulon
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Hungary
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Balassagyarmat
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Hungary
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Budapest
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Gyor
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Gyula
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Ahmedabad
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India
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Bangalore
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India
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Jaipur
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India
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Kalyan
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Mangalore
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India
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Nashik
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India
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Pune
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India
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Vadodara
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Korea, Republic of
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Busan
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Gwangju
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Gyeonggi-do
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Incheon
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Korea, Republic of
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Jeollabuk-do
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Seoul
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Mexico
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Mexico
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Monterrey
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Mexico
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San Luis Potosi
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Romania
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Arad
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Romania
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Bucuresti
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Romania
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Cluj-Napoca
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Romania
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Lasi
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Romania
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Oradea
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Romania
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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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Russian Federation
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Moscow Region
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Russian Federation
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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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Russian Federation
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St Petersburg
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Russian Federation
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St. Petersburg
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Russian Federation
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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01235520