E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder NOS or any other psychotic disorder patients demanding long term antipsychotic treatment |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037253 |
E.1.2 | Term | Psychotic disorder NOS |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061920 |
E.1.2 | Term | Psychotic disorder |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10039628 |
E.1.2 | Term | Schizophrenia and other psychotic disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10012256 |
E.1.2 | Term | Delusional disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039621 |
E.1.2 | Term | Schizoaffective disorder |
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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 |
The primary objective of the study is to compare overall patient treatment satisfaction with current medication in patients with schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder NOS (not otherwise specified) or any other psychotic disorder. Three treatment groups will be included: 1) Atypical oral antipsychotics; 2) Conventional LAI antipsychotics; 3) Atypical LAI antipsychotic (Risperdal Consta®). |
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E.2.2 | Secondary objectives of the trial |
Patient perception of efficacy and effectiveness, functioning, adverse events and adherence with their current treatment will be investigated. Patient attitudes towards, and preferences for, administration formulation, as well as their perception of information received regarding different treatment options will also be studied. For patients on atypical oral therapy without previous experience of LAI therapy specific questions will address willingness to consider antipsychotic LAI therapy as a treatment option. Physicians’ clinical global impression of severity, assessment of adherence and patient medication satisfaction, and attitudes towards different types of antipsychotic treatment will be studied. Physicians’ reasons for prescribing, and switching between, the different treatment options will be investigated. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Written informed consent obtained from patient; 2. Male or female adult patient >= 18 years old; 3. Patient diagnosed with schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder NOS or any other psychotic disorder demanding long term antipsychotic treatment; 4. The patient’s psychotic symptoms has, according to clinical judgment, been stable during the past three months without a need for major interventions due to clinical deterioration (like hospitalization and/or major changes in medication); 5. Patients current main antipsychotic therapy is: a. Atypical oral antipsychotic; or b. Atypical long acting injectable (LAI) antipsychotic; or c. Conventional LAI antipsychotic. 6. Patient should have been treated with their current main antipsychotic therapy for a minimum of 6 months and a maximum of 24 months. |
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E.4 | Principal exclusion criteria |
1. Patient experiencing an acute relapse/exacerbation of schizophrenia symptoms; 2. Patient registered on involuntary/compulsory therapy (LPT and forensic patients); 3. Patient currently participating in a randomized controlled trial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of the study is to compare overall patient treatment satisfaction with current medication in patients with schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder NOS (not otherwise specified) or any other psychotic disorder. Three treatment groups will be included: 1) Atypical oral antipsychotics; 2) Conventional LAI antipsychotics; 3) Atypical LAI antipsychotic (Risperdal Consta®). |
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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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Treatment satisfaction with current treatment |
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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 | 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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 9 |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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 | |
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 months | 6 |