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. |
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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 | 14.1 |
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 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. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are to evaluate effects of 12 weeks of treatment with RO4917838 vs. placebo in patients with suboptimally controlled symptoms of schizophrenia treated with antipsychotics with respect to: • Symptoms domains of schizophrenia: PANSS total score, PANSS factor score of negative symptoms, disorganized thought, hostility/excitement, anxiety/depression; and PANSS syndrome subscale scores of positive, negative and general psychopathology symptoms at week 12; • The Clinical Global Impression - Improvement (CGI-I) positive and overall symptoms with “much” or “very much” improvement at week 12; • Clinical Global Impression - Severity (CGI-S) on overall and positive symptoms at week 12; • Personal and Social Performance (PSP) total score at 12 week; • Safety and tolerability of 52 weeks randomized study treatment. |
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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 12 weeks prior to screening period - Antipsychotic treatment stability for 8 weeks prior to screening period - With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (treatment with a maximum of two antipsychotics) |
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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 has anorexia or obesity (body mass index (BMI) <18.5 or >40, respectively) - Diagnosis of mental retardation or severe organic brain syndromes - In the investigator's judgment, a significant risk of suicide or violent behavior |
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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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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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) |
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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 |
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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 | 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 |
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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 | 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.8.3 |
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 | 5 |
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 |
Brazil |
Canada |
Germany |
Latvia |
Lithuania |
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 |