E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Schizophrenia, schizoaffective disorder |
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MedDRA Classification |
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 |
To test the hypothesis that patients with good premorbid functioning, as assessed using the Premorbid Adjustment Scale, will respond better to treatment as measured by changes from baseline on the PANSS total score and CGI-S than patients with poor premorbid functioning. |
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E.2.2 | Secondary objectives of the trial |
(a) to assess the effectiveness, safety, tolerability, and functioning of patients in the early phase of psychosis who are treated with of Risperdal Consta as follows: " Effectiveness: via CGI-S/C, PANSS, retention rate " Functioning: (SF-36); rehospitalisation rates " Safety and tolerability: via reported adverse events, ESRS and retention rate (b) Examine whether greater insight, as measured by the SAI-E and PANSS, is positively associated with better outcomes |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
" Male or female. " Age >18 years. " Primary diagnosis of schizophrenia/schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV-TR). " Primary diagnosis for less than 2 years following initial diagnosis and treatment. " At least 2 previous psychotic episodes. " Maximum total PANSS score of 80. " Patients who, in the opinion of the investigator, require at least 6 months treatment with antipsychotic medication. " Patients may be currently treated with any antipsychotic (with the exception of clozapine and depot neuroleptics) at doses not exceeding the registered highest recommended dose. " Female patients must be surgically sterile, or practicing an effective method of birth control (e.g. prescription oral contraceptives, contraceptive injections, intra-uterine device, double-barrier method, contraceptive patch, male partner sterilization or abstinence) before entry and throughout the study; and have a negative pregnancy test at baseline, before study entry. " Patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. |
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E.4 | Principal exclusion criteria |
" DSM-IV-TR Axis I diagnosis other than schizophrenia or schizoaffective disorder. " Patients already on treatment with Risperdal Consta. " Patients requiring treatment at entry with mood stabilizers or antidepressants may enter the study only if a stable dose has been received for 3 months prior to study entry. " Pregnant or breast-feeding females. " Patients who have previously received treatment with clozapine. " Evidence of alcohol or drug dependence (except for nicotine and caffeine dependence according to DSM-IV-TR criteria diagnosed in the last month prior to entry). " History of severe drug allergy, drug hypersensitivity or neuroleptic malignant syndrome. " Known hypersensitivity/intolerance or previous non-response to oral risperidone proven by adequate drug plasma levels (non-responders due to non-compliance are not excluded). " Patients who are known non-responders to previous treatment with at least 2 antipsychotics. " Serious, unstable and untreated medical illnesses. " Patients with conditions and symptoms that are listed in the SmPC under special warnings and special precautions for use " Patients with mental retardation. " Known clinically significant ECG abnormality. " Patients at acute risk of suicide in the investigators opinion at study entry or history of suicidal attempt(s) in the last 3 months before the study entry. " Patients having received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment. " Patients with known phenylketonuria. " Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical Response (improvement) rate defined as >=20% improvement on PANSS total score from baseline to endpoint. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
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.8.5 | The trial involves multiple Member States | Yes |
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 |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |