E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Symptomatic schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder or psychotic disorder not otherwise specified |
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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 |
Primary study objective is to assess the effect of quetiapine XR with or without concomitant participation in the ICP on the subjective well-being in patients treated for symptomatic schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder or psychotic disorder not otherwise specified, measured by the patients' self-report instrument SWN-K total score with a result of ≥ 80 defined as the response limit for an adequate subjective well-being over a study treatment period of 18 months.
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E.2.2 | Secondary objectives of the trial |
Secondary outcome measures to assess the treatment efficacy, compliance, quality of life, health economy issues and safety/tolerability.
Secondary study objectives will evaluate the influence of quetiapine XR with or without ICP participation on the following parameters during the study period: Subjective well-being by SWN-K total score, symptomatic outcome by CGI-S and PANSS-8 scale, functional outcome by GAF, PSP, EQ-5D, and Vocational Occupational Index scores, quality of life by Q-LES-Q-18 questionnaire and RSM scale, patient engagement to therapy by SES scale, compliance/medication adherence by MARS scale, level of the patients' (subjective) satisfaction by CSQ-8 scale, health economy improvements, Safety and tolerability by evaluation of vital signs including weight/waist circumference, laboratory tests, concomitant medication, and the incidence of adverse events
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Provision of written informed consent to take part in the study 2. If applicable according to the intended treatment group allocation: Provision of written informed consent to start participation in an integrated health care program (ICP; the offered ICP services must be covered by a contract according to §§ 140 a-d SGB-V) 3. Patients with a baseline SWN-K total score of ≤ 70 4. Male and female out-patients aged between 18 and 65 years 5. Treated or need of treatment for symptomatic schizophrenia (F20), schizo-affective disorder (F25), schizophreniform disorder (F23), delusional disorder (F22) or psychotic disorder not otherwise specified (F29), confirmed according to the ICD-10 definitions 6. Female patients of childbearing potential must have a negative serum pregnancy test at enrolment 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 7. Ability to understand and comply with the study requirements as per the investigator
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E.4 | Principal exclusion criteria |
1. Current or previous participation in an integrated care program 2. Patients who in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others 3. Evidence of clinically relevant disease, e.g., renal or hepatic impairment, significant coronary artery disease, cerebrovascular disease, viral hepatitis B or C, acquired immunodeficiency syndrome (AIDS) as judged by the investigator 4. Patients with known cardiovascular diseases or other conditions predisposing to hypotension or family history of QT prolongation 5. Administration of a depot antipsychotic medication within one dosing interval prior to enrolment
6. Use of drugs that induce or inhibit the hepatic metabolizing CYP3A4 enzymes within 2 weeks prior to enrolment and throughout the 18-month treatment phase of the study (e.g., inducers: phenytoin, carbamazepine, phenobarbital, rifampicin, rifabutin, glucocorticoids, thioridazine and St John’s wort. E.g., inhibitors: ketoconazole (except for topical use), itraconazole, fluconazole, erythromycin, clarithromycin, fluvoxamin, nefadozone, troleandomycin, indinavir, nelfinavir, ritonavir and saquinavir). 7. Patients who are pregnant or lactating 8. Known intolerance or lack of response to the substance quetiapine 9. Neutropenia with an absolute neutrophil count (ANC) of 1.5 x 109 per litre. 10. Patients with unstable diabetes mellitus (DM)/HbA1c fulfilling one of the following criteria: - Unstable DM defined as enrolment glycosylated haemoglobin (HbA1c) > 8.5% - Patients admitted to hospital for treatment of DM or DM related illness in past 12 weeks - Patients not under physician care for DM; - Physician responsible for patient’s DM care has not indicated that patient’s DM is controlled or has not approved patient’s participation in the study - Patient has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to enrolment - for thiazolidinediones (glitazones) not less than 8 weeks - Patients 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 must be excluded even if the treating physician believes that the patient is stable and can participate in the study.) 11. Any contraindication as detailed in the German SmPC for quetiapine XR 12. Participation in another drug trial within 4 weeks prior enrolment into this study 13. Previous enrolment in the present study or CARE NIS 14. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome variable is the rate of patients with SWN-K score ≥ 80 after 18 months. Exploratory 95% CIs will be calculated for this primary variable for each treatment group as well as for the difference between the treatment groups. |
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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 | Yes |
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 | Yes |
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Participation in an Integrated Care Program at ratio of 3:1 |
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E.8.3 |
The trial involves single site in the Member State concerned
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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 | 30 |
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 | 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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End of study will be database lock defined as time after which no patient is exposed to study related activities |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |