E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of negative symptoms for patients with schizophrenia treated with antipsychotics |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 15.1 |
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 |
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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 efficacy of 24 weeks treatment with RO4917838 in the PANSS negative symptom factor score in patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics. • Evaluate safety and tolerability of 24 weeks treatment with RO4917838 in patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics. |
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E.2.2 | Secondary objectives of the trial |
Evaluate efficacy after 24 weeks of treatment with RO4917838 in patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics: • PANSS NSFS in the CFHR1-high subgroup • personal and social functioning using PSP total score in the all-patient population and in the CFHR1-high subgroup Additional objectives: evaluate the effect of treatment with RO4917838 in patients with persistent, predominant negative symptoms of schizophrenia, 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: positive symptom, disorganized thought, hostility/excitement, anxiety/depression; PANSS subscales: positive, negative and general psychopathology at week 24; • Clinical Global Impression of severity and improvement on overall and negative symptoms at week 24; • Safety/tolerability of 52 weeks of randomized study treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Adult patients, aged 18 years and above • Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype • Predominant negative symptoms • With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics) |
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E.4 | Principal exclusion criteria |
• Evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder) • Patient with body mass index (BMI) < 17 kg/m2 or > 40 kg/m2 • 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 ESRS-A (Clinical Global Impression, Parkinsonism). |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Efficacy (PANSS negative symptoms factor score) 2. Safety (incidence of adverse events) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Efficacy (PANSS negative symptoms factor score) Time frame: Week 24 2. Safety (incidence of adverse events) Time frame: Week 24 |
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E.5.2 | Secondary end point(s) |
The key secondary efficacy endpoint is the mean change from baseline in the Personal and Social Performance (PSP) total score. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 and Biomarker |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
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 | No |
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 |
Brazil |
Canada |
Germany |
Latvia |
Lithuania |
Netherlands |
Poland |
Slovakia |
Spain |
Taiwan |
Ukraine |
United States |
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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
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The study will end when the last randomized patient completes the last assessment 4 weeks after the last dose taken. |
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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 |