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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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United States of America
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Arkansas
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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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United States of America
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Maryland
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United States of America
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Missouri
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New Jersey
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United States of America
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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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Caba
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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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Kuopio
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France
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Caen
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Clermont-ferrand
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France
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Dole
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Budapest
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Gyor
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Ahmedabad
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Jaipur
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India
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Incheon
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Seoul
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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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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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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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Stockholm
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Sweden
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Uppsala
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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 multi-center, randomized, double-blind, parallel-group, placebo-controlled study will
evaluate the efficacy and safety of RO4917838 in participants with persistent, predominant
negative symptoms of schizophrenia. Participants, on stable treatment with antipsychotics,
will be randomized to receive daily oral doses of RO4917838 or matching placebo for 56 weeks
(treatment period 1 of 24 weeks and treatment period 2 of 32 weeks), followed by an optional
treatment extension for up to 3 years. After 52 weeks, participants who were originally
randomized to an active treatment will be randomly assigned to receive either placebo or
continue on the originally assigned study treatment for 4 weeks washout period (Week 52 to
Week 56) for the assessment of potential withdrawal effects in a blinded manner using
participants staying on active treatment as a control. Participants initially randomized to
placebo will remain on placebo. After 56 weeks, participants who were switched to placebo in
the washout period will return to their blinded, active treatment arm.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01192867
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01192867