E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 a 12-week treatment with aripiprazole in a broad range of schizophrenic patients. The overall effectiveness will be evaluated by the CGI-I at Week 12. |
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E.2.2 | Secondary objectives of the trial |
1) To correlate evaluation of treatment effectiveness by: - Physicians: CGI-S scale, CGI Therapeutic Index scale, IAQ questionnaire - Patients: PGI-I scale, QLESQ questionnaire, POM questionnaire - Care givers and/or family: PGI-I scale and POM questionnaire 2) To evaluate cognitive function by California Verbal Learning Test and Verbal Fluency. 3) To evaluate compliance by drug accountability records and by Drug Attitude Inventory (DAI) questionnaire. 4) To evaluate safety and tolerability by the incidence and severity of adverse events, serious adverse events, discontinuation from study due to adverse events and weight changes.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Patients must be competent to understand the nature of the study, sign the informed consent, agree to comply with prescribed dosage regimens, report for regularly scheduled visits with their caring physician, able to provide reliable information for safety, efficacy and Quality of life assessments and communicate to the psychiatrist about adverse events and concomitant medication use; - The informed consent process must be documented by signing the informed consent form prior to any study-related procedures including alteration in medications in preparation for study entry; - Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR2 criteria; - Patients with a score of 2 to 6 in the CGI-S scale at baseline; - Either ambulatory or hospitalized patients having symptoms which in the clinical judgment of the treating psychiatrist require treatment with antipsychotic medication (AP); this includes: patients in whom an AP is started and patients who, stabilized or not stabilized, in the clinical judgment of the treating psychiatrist, require a change of their current AP treatment; because of lack of efficacy or because of occurrence of side effects; - Men and women, aged of minimum 18; - Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized; - WOCBP must have a negative serum or urine pregnancy test within 72 hours prior to the start of study medication.
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E.4 | Principal exclusion criteria |
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study; - WOCBP using a prohibited contraceptive method; - Women who are pregnant or breastfeeding; - Women with a positive pregnancy test on enrollment or prior to study drug administration; - Patients with a diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic symptoms, or organic brain syndromes; - Patients with a score of 0 (not assessed) -1 (normal, not at all ill) or 7 (amongst the most extremely ill patients) in the CGI-S scale at baseline; - Patients who have met DSM-IV-TR criteria for any significant Psychoactive Substance Use Disorder within the 3 months prior to Screening; - Treatment with a long-acting antipsychotic in which the last dose was within 3 weeks of randomization; - Patients with a history of neuroleptic malignant syndrome; - Patients with epilepsy, a history of seizures (except for a single childhood febrile seizure), a history of stroke or who have a history or evidence of other medical conditions that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial; - Patients who would be likely to require prohibited concomitant therapy during the trial; - Patients who have participated in any clinical trial with an investigational agent within the past month; - Patients who are known to be allergic or hypersensitive to aripiprazole or other dihydrocarbostyrils; - Prisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness. |
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E.5 End points |
E.5.1 | Primary end point(s) |
CGI – Improvement (CGI-I) scale at week 12 |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | 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 | No |
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 | 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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The end of the open-label treatment phase will be the date of the last visit of the last patient in this phase of the study, ie maximum 12 weeks after the last patient enrolls in the study. For all patients, the extension phase will end when the product will be commercially available in Belgium. The last visit is expected to be on the same day as the last treatment administered. |
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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 | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |