E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Schizophrenia or 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 evaluate the effectiveness of eight weeks of treatment with aripiprazole in patients diagnosed with schizophrenia or schizoaffective disorder who are treated in an outpatient psychiatric setting. The overall effectiveness of aripiprazole will be evaluated by use of the CGI-I scale. The evaluation of effectiveness will encompass the patients’ psychopathology, including efficacy, safety and tolerability. |
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E.2.2 | Secondary objectives of the trial |
The effectiveness of aripiprazole will be further assessed by evaluating: The Clinical Global Impression - Severity of Illness (CGI-S) score; The BPRS Total score; Investigator’s assessment Questionnaire (IAQ); Quality of Life Enjoyment and Satisfaction Questionnaire (assessed by the Q-LES-Q scale); Patients’ and caregivers’ medication preference (assessed by the POM questionnaire); The safety and tolerability of aripiprazole.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients with a diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV-TR criteria who are being managed as outpatients [Hospitalization of patients will be allowed for non medical reasons only (e.g. social reasons, local policy). Patients requiring hospitalization for medical reasons (whether or not related to schizophrenia or schizoaffective disorder) will be excluded from the trial] and have symptoms which in the clinical judgment of the treating psychiatrist require treatment with antipsychotic medication;
Patients whose symptoms are not optimally controlled defined as CGI-S < 7 and/or whose antipsychotic medication is not well-tolerated defined as clinically significant EPS verified by SAS and/or verified hyperprolactinemia defined as prolactin level above the upper limit of normal (ULN) and/or weight gain defined as increase of BMI by 5% during the previous treatment, which in the clinical judgment of the treating psychiatrist require a change of treatment or initiation of treatment with antipsychotic medication;
Patients who have received adequate treatment with antipsychotics in the past must have shown a response to a neuroleptic medication other than clozapine;
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E.4 | Principal exclusion criteria |
Patients who are at risk for committing suicide: either having active suicidal ideation considered clinically significant or recently attempted suicide;
Patients with a diagnosis of mood disorders, mental disorder due to general medical condition, delirium, dementia and amnestic and other cognitive disorder;
Patients who have met DSM-IV-TR criteria for any significant psychoactive substance use disorder within the 3 months prior to Screening;
Patients considered treatment-resistant to antipsychotic medication (patients need to have shown a previous response to a antipsychotic medication other than clozapine) and patients with a significant history of intolerance to multiple antipsychotic treatments;
Treatment with a long-acting antipsychotic (i.e. haloperidol decanoate, fluphenazine decanoate, etc.) in which the last dose was within 3 months of treatment phase;
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary effectiveness analysis will be a comparison of the upper bound of the 95% confidence interval (CI) for the mean score of aripiprazole patients on the CGI-I at Week 8 to a score of 4 (no change). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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.8.5 | 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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End of the trial defined in the protocol (section 3.1.1) as LPLV. |
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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 | 8 |
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 | 8 |