| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Patients with a diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder |
|
| MedDRA Classification |
| 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 | 10039620 |
| E.1.2 | Term | Schizoaffective and schizophreniform disorders |
|
| 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 this study is to demonstrate the non-inferiority of quetiapine XR to risperidone assessed at month 6 in terms of responder rate using the self-report instrument SWN-K. |
|
| E.2.2 | Secondary objectives of the trial |
| To demonstrate the non-inf. of quetiapine XR to risperidone assessed at month 12 by evaluating the change from baseline in SWN-K mean total score. Other secondary objectives are to evaluate in both treatment groups the following outcomes throughout the study: 1.Subjective changes using the SWN-K scale. 2.Remission rate during the study using the SWN-K scale, defined as a total score of >=80 points. 3. Severity of patient symptoms using the CGI-SCH scale. 4.Depressive symptoms changes using the CDSS. 5.Relapse rate in terms of symptoms and/or re-hospitalization. 6.QoL changes using the EQ-5D. 7.Resource utilization for health economics (modified vocational status index/modified location code index, loss of school/work days, total number of days of hospitalization, emergency visits and n. of outpatient visits,time to rehospitalization,need for additional treatment for despite stable antipsychotic treatment for at least 1 month) 8.Safety and tolerability 9.Compliance |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
| 1. Provision of written informed consent. Patients who are deemed incapable of providing informed consent may be enrolled if written informed consent has been obtained from the patientŽs Legally Acceptable Representative in accordance with local regulations 2. Male and female out-patients aged between 18 and 65 years 3. Treated for symptomatic schizophrenia (DSM-IV-TR codes: 295.10, 295.20, 295.30,295.60, 295.90) or schizoaffective disorder (DSM-IV-TR code:295.70) or schizophreniform disorder (DSM-IV-TR code: 295.40). Patients with co-morbid depressive symptoms may be enrolled 4. Patient with first episode of the above mentioned disease (item 3) or patient requiring a medication change for clinical reasons (effectiveness, tolerability, compliance, patient preference), i.e. switch from typical to atypical neuroleptics, switch from other atypical neuroleptics, excluding patients treated with risperidone or quetiapine at the time of enrolment 5. Female patients of childbearing potential must have a negative urine pregnancy test at enrolment and confirmed by serum pregnancy test and be willing to use a reliable method of birth-control, i.e. double-barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study, as judged by the investigator 6. Be able to understand and comply with the study requirements as judged by the investigator |
|
| E.4 | Principal exclusion criteria |
| 1. Patients with a baseline SWN-K total score of >75 2. Patients with previous treatment with risperidone or quetiapine may be enrolled if change of treatment has not been dictated by major lack of tolerability and efficacy 3. Patients taking antidepressant drugs or mood stabilizers who are not on a stable dose since at least 2 weeks prior to enrolment 4. Patients with known Diabetes Mellitus (DM) fulfilling one of the following criteria: − Known history of unstable DM defined as glycosylated hemoglobin (HbA1c) >8.5%. − Admitted to hospital for treatment of DM or DM related illness in past 12 weeks. − Not under physician care for DM. − Physician responsible for patient’s DM care has not indicated that patient’s DM is controlled. − Physician responsible for patient’s DM care has not approved patient’s participation in the study. − Patients has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomization. For thiazolidinediones (glitazones) this period should not be less than 8 weeks. − Patient taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks. Note: if a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study. Upon receipt of visit 1 lab results the investigator will withdraw the patient from the study if HbA1c > 8.5%. 5. Evidence of clinically relevant disease, eg, renal or hepatic impairment, significant coronary artery disease, congestive heart failure, cerebrovascular disease, viral hepatitis B or C, acquired immunodeficiency syndrome (AIDS) as judged by the investigator 6. Pregnancy or Lactation 7. Use of potent cytochrome P450 3A4 inducers (eg barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin, rifabutin, thioridazine and St. John’s Wort) in the 14 days preceding randomization 8. Use of potent cytochrome P450 3A4 inhibitors (eg macrolide antibiotics [clarithromycin,erythromycin, troleandomycin], azolantifungals [fluconazole, itraconazole, ketoconazole except for topical use], protease inhibitors [indinavir, nelfinavir, ritonavir, saquinavir], fluvoxamine, nefazodone) in the 14 days preceding randomization 9. Contraindications as detailed in the country – specific prescribing information for quetiapine XR and risperidone 10. Patients with known cardiovascular disease or other conditions predisposing to hypotension or family history of QT prolongation 11. Patients at an imminent risk to commit suicide, based on the investigators judgement 12. Treatment-resistant patients defined as not responding to optimal dose of 2 successive antipsychotics 13. Known history of intolerance or hypersensitivity to quetiapine, risperidone or to any other compound in the tablets 14. Administration of a depot antipsychotic medication within one dosing interval prior to randomization 15. Involvement in the planning and conduct of the study (applies to both AZ staff or staff at the study site) 16. Previous enrolment or randomisation of treatment in the present study 17. Participation in another drug trial within 4 weeks prior to enrolment into this study or longer (in accordance with local requirement) 18. Possible risk factors for neutropenia including pre-existing low white cells count and history of drug-induced neutropenia (note: upon receipt of visit 1 lab results the investigator will withdraw the patient from the study if the absolute neutrophil count (ANC) <= 1.5x109/L) |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| the primary endpoint is the responder rate estimated from the change from baseline in SWN-K score |
|
| 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 | No |
| 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 | 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) | 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 | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| 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) | Yes |
| 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.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
| 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 |
|
| 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
| |
| 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 | 7 |
| 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 | 7 |
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