E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adjunctive treatment of patients with sub-optimally controlled symptoms of schizophrenia. Sub-optimally controlled patients are defined as those who on their current medication have persistent symptoms of psychosis. |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039626 |
E.1.2 | Term | Schizophrenia |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• Evaluate the efficacy after 12 weeks of treatment with RO4917838 vs. placebo, as adjunct to antipsychotics, in the PANSS positive symptom factor score in patients with suboptimally controlled symptoms of schizophrenia;
• Evaluate the safety and tolerability after 12 weeks of treatment with RO4917838 vs. placebo as adjunct to antipsychotics, in patients with sub-optimally controlled symptoms of schizophrenia. |
|
E.2.2 | Secondary objectives of the trial |
Evaluate efficacy after 12 weeks of treatment with RO4917838 as
adjunct to antipsychotics, in the PANSS PSFS in the CFHR1-high
subgroup of patients with sub-optimally controlled symptoms of
schizophrenia
Additional objectives: evaluate the effects of 12 weeks of treatment with
RO4917838 in patients with suboptimally controlled symptoms of
schizophrenia treated with antipsychotics in the all-patient population
and the CFHR1 subgroups according to patient's CFHR1 serum at
baseline with respect to:
• Other symptom domains of schizophrenia: PANSS total score; PANSS
factors: negative symptom, disorganized thought, hostility/excitement,
anxiety/depression; PANSS subscales: positive, negative and general
psychopathology at week 12;
• CGI-I and CGI-S on overall and negative symptoms at week 12;
• PSP total score at 12 week;
• Safety/tolerability of 52 weeks of randomized study treatment. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adult patients, >/= 18 years of age
- Diagnosis of schizophrenia
- Clinical stability for 16 weeks prior to randomization
- Antipsychotic treatment stability for 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) |
|
E.4 | Principal 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 with body mass index (BMI) < 17 kg/m2 or > 40 kg/m2
- Diagnosis of mental retardation or severe organic brain syndromes
- In the investigator's judgment, a significant risk of suicide or violent behavior |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Efficacy (PANSS positive symptoms factor score) Timeframe: Week 12
- Safety (incidence of adverse events) Timeframe: Week 12 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS)
2. Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale
3. Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale
4. Safety (incidence of adverse events) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Time Frame: Change from baseline to Week 12
2. Time Frame: Change from baseline to Week 12
3. Time Frame: Change from baseline to Week 12
4. Time Frame: Week 52 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability / Quality of Life / Biomarkers |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Netherlands |
Slovakia |
Brazil |
Germany |
Latvia |
Lithuania |
Spain |
Poland |
Taiwan |
Ukraine |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The study will end when the last randomized patient completes the last assessment 4 weeks after the last dose taken. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |