Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01192867




Registration number
NCT01192867
Ethics application status
Date submitted
30/08/2010
Date registered
1/09/2010
Date last updated
26/06/2017

Titles & IDs
Public title
A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)
Scientific title
A Phase III, Multi-Center, Randomized, 24 Week, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate Efficacy and Safety of RO4917838 in Stable Patients With Persistent, Predominant Negative Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 28 Week, Double-Blind Treatment Period
Secondary ID [1] 0 0
2010-020370-42
Secondary ID [2] 0 0
NN25310
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 - Antipshychotics (Standard of Care)

Experimental: RO4917838 20 milligrams (mg) - Participants, on stable antipsychotics, will receive RO4917838 orally at 20 mg once daily (QD) up to 56 weeks followed by an optional treatment extension for up to 3 years.

Experimental: RO4917838 10 mg - Participants, on stable antipsychotics, will receive RO4917838 orally at 10 mg QD up to 56 weeks followed by an optional treatment extension for up to 3 years.

Placebo comparator: Placebo - Participants, on stable antipsychotics, will receive RO4917838 matching placebo orally QD up to 56 weeks.


Treatment: Drugs: Placebo
Placebo will be administered orally QD for 56 weeks

Treatment: Drugs: RO4917838
RO4917838 will be administered orally at 20 or 10 mg QD for 56 weeks.

Treatment: Drugs: Antipshychotics (Standard of Care)
Participants will continue to receive their stable antipshychotic as standard of care based on their prescription up to Week 56.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in the Positive and Negative Symptoms Scales (PANSS) Negative Symptoms Factor Score at Week 24 (All-Participant Population)
Timepoint [1] 0 0
Baseline, Week 24
Primary outcome [2] 0 0
Percentage of Participants With Adverse Events (All-Participant Population)
Timepoint [2] 0 0
Week 24
Secondary outcome [1] 0 0
Change From Baseline in the PANSS Negative Symptoms Factor Score at Week 24 (Complement Factor H Related Protein 1 High [CFHR1-High] Subgroup Population)
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [2] 0 0
Change From Baseline in the Personal and Social Performance (PSP) Total Score at Week 24 (All-Participant Population)
Timepoint [2] 0 0
Baseline, Week 24
Secondary outcome [3] 0 0
Change From Baseline in the PSP Total Score at Week 24 (CFHR1-High Subgroup Population)
Timepoint [3] 0 0
Baseline, Week 24
Secondary outcome [4] 0 0
Change From Baseline in the PANSS Total Score at Week 24 (All-Participant Population)
Timepoint [4] 0 0
Baseline, Week 24
Secondary outcome [5] 0 0
Change From Baseline in the PANSS Total Score at Week 24 (CFHR1-High Subgroup Population)
Timepoint [5] 0 0
Baseline, Week 24
Secondary outcome [6] 0 0
Change From Baseline in the PANSS Factor Score at Week 24 (All-Participant Population)
Timepoint [6] 0 0
Baseline, Week 24
Secondary outcome [7] 0 0
Change From Baseline in the PANSS Factor Score at Week 24 (CFHR1-High Subgroup Population)
Timepoint [7] 0 0
Baseline, Week 24
Secondary outcome [8] 0 0
Change From Baseline in the PANSS Subscale Scores at Week 24 (All-Participant Population)
Timepoint [8] 0 0
Baseline, Week 24
Secondary outcome [9] 0 0
Change From Baseline in the PANSS Subscale Scores at Week 24 (CFHR1-High Subgroup Population)
Timepoint [9] 0 0
Baseline, Week 24
Secondary outcome [10] 0 0
Percentage of Participants Who Have at least 20 Percent (%) Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 (All-Participant Population)
Timepoint [10] 0 0
Baseline, Week 24
Secondary outcome [11] 0 0
Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 (CFHR1-High Subgroup Population)
Timepoint [11] 0 0
Baseline, Week 24
Secondary outcome [12] 0 0
Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score for Two out of Three Assessments During 24 Weeks (All-Participant Population)
Timepoint [12] 0 0
Baseline up to Week 24
Secondary outcome [13] 0 0
Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score for Two out of Three Assessments During 24 Weeks (CFHR1-High Subgroup Population)
Timepoint [13] 0 0
Baseline up to Week 24
Secondary outcome [14] 0 0
Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on Clinical Global Impression - Improvement (CGI-I) Score (All-Participant Population)
Timepoint [14] 0 0
Baseline, Week 24
Secondary outcome [15] 0 0
Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on CGI-I Score (CFHR1 Subgroup Population)
Timepoint [15] 0 0
Baseline, Week 24
Secondary outcome [16] 0 0
Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on CGI-I Score for Two out of Three Assessments During 24 Weeks (All-Participant Population)
Timepoint [16] 0 0
Baseline up to Week 24
Secondary outcome [17] 0 0
Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on CGI-I Score for Two out of Three Assessments During 24 Weeks (CFHR1 Subgroup Population)
Timepoint [17] 0 0
Baseline up to Week 24
Secondary outcome [18] 0 0
Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score (All-Participant Population)
Timepoint [18] 0 0
Baseline, Week 24
Secondary outcome [19] 0 0
Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score (CFHR1 Subgroup Population)
Timepoint [19] 0 0
Baseline, Week 24
Secondary outcome [20] 0 0
Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score for Two out of Three Assessments During 24 Weeks (All-Participant Population)
Timepoint [20] 0 0
Baseline up to Week 24
Secondary outcome [21] 0 0
Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score for Two out of Three Assessments During 24 Weeks (CFHR1 Subgroup Population)
Timepoint [21] 0 0
Baseline up to Week 24
Secondary outcome [22] 0 0
Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 and Improvement in the Negative Symptoms Based on CGI-I Negative Symptoms Score (All-Participant Population)
Timepoint [22] 0 0
Baseline, Week 24
Secondary outcome [23] 0 0
Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 and Improvement in the Negative Symptoms Based on CGI-I Negative Symptoms Score (CFHR1 Subgroup Population)
Timepoint [23] 0 0
Baseline, Week 24
Secondary outcome [24] 0 0
Change From Baseline in Severity of Illness Based on Clinical Global Impression - Severity (CGI-S) Overall Score (All-Participant Population)
Timepoint [24] 0 0
Baseline, Week 24
Secondary outcome [25] 0 0
Change From Baseline in Severity of Illness Based on CGI-S Overall Score (CFHR1 Subgroup Population)
Timepoint [25] 0 0
Baseline, Week 24
Secondary outcome [26] 0 0
Change From Baseline in Severity of Illness Based on CGI-S Negative Symptoms Score (All-Participant Population)
Timepoint [26] 0 0
Baseline, Week 24
Secondary outcome [27] 0 0
Change From Baseline in Severity of Illness Based on CGI-S Negative Symptoms Score (CFHR1 Subgroup Population)
Timepoint [27] 0 0
Baseline, Week 24

Eligibility
Key inclusion criteria
* Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype
* Predominant negative symptoms
* With the exception of clozapine, participants are on any of the available marketed atypical or typical antipsychotics (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
* Evidence that participant has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
* Body Mass Index (BMI) of less than (<) 17 or greater than (>) 40 kilograms per meter square (kg/m^2)
* Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS)
* A severity score of 3 or greater on the Parkinsonism item of the Exrapyramidal Symptoms Rating Scale-Abbreviated (ESRS-A) (Clinical Global Impression, Parkinsonism)

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
11/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/05/2014
Sample size
Target
Accrual to date
Final
629
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Westmead Hospital; Department of Psychiatry - Westmead
Recruitment hospital [2] 0 0
Monash Medical Centre-Clayton Campus; School of Psychology and Psychiatry - Clayton
Recruitment hospital [3] 0 0
Frankston Hospital; Mental Health Service - Frankston
Recruitment hospital [4] 0 0
The Alfred Hospital; Monash Alfred Psychiatry Research Centre (MAP-RC) - 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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New Mexico
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
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United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Argentina
State/province [17] 0 0
Buenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
Caba
Country [19] 0 0
Argentina
State/province [19] 0 0
Ciudad Autonoma Bs As
Country [20] 0 0
Argentina
State/province [20] 0 0
Ciudad de Mendoza
Country [21] 0 0
Argentina
State/province [21] 0 0
Cordoba
Country [22] 0 0
Argentina
State/province [22] 0 0
La Plata
Country [23] 0 0
Argentina
State/province [23] 0 0
Mendoza
Country [24] 0 0
Argentina
State/province [24] 0 0
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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Kuopio
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France
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Caen
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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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France
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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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Hungary
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Gyor
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Gyula
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India
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Ahmedabad
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India
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Jaipur
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India
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Kalyan
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India
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Mangalore
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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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Korea, Republic of
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Gwangju
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Incheon
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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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Russian Federation
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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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Russian Federation
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Saint Petersburg
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Russian Federation
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Samara
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Russian Federation
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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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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/NCT01192867