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 |
The primary objective is to document the clinical benefit of quetiapine SR after switching from other ongoing antipsychotic treatment, regardless of the reason for the switch. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to document improved tolerability, safety or efficacy after switching to quetiapine SR from other ongoing antipsychotic treatment, regardless of the reason for switch. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
For inclusion in the study patients must fulfill all of the following criteria:
1. Provision of written informed consent. Only patient deemed fully capable are allowed to be enrolled to the study. Inclusion in the genetic part of the study is under provision of a written informed consent separate from the main study. 2. Female and male age more than or equal to 18 and less than or equal to 65 years 3. Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for any of the following: Schizophrenia DSM-IV catatonic 295.20 disorganised 295.10 paranoid 295.30 undifferentiated 295.90 4. Patients who in their own and/or in the Investigator’s opinion, consider ongoing antipsychotic treatment inadequate, because of insufficient efficacy and/or tolerability. 5. 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, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study. 6. Be able to understand and comply with the requirements of the study, as judged by the Investigator.
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E.4 | Principal exclusion criteria |
1. Meeting the criteria for any other (than schizophrenia) DSM-IV Axis I diagnosis, concomitant organic mental disorder or mental retardation. 2. Substance abuse or dependence as defined by DSM-IV and not in full remission. A urine drug screen test will be performed. The Investigator will evaluate the results along with medical history to determine if the patient meets DSM-IV criteria for substance abuse or dependence. 3. Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B, via blood or other body fluids as judged by the Investigator. 4. Patients who, in the opinion of the Investigator, pose an imminent risk of suicide or a danger to self or others. 5. History of non-compliance as judged by the Investigator. 6. Evidence of clinically relevant disease, (eg, renal or hepatic impairment, significant coronary artery disease, cerebrovascular disease, viral hepatitis B or C, acquired immunodeficiency syndrome [AIDS] or cancer) or a clinical finding that is unstable or that, in the opinion of the Investigator, would be negatively affected by the investigational product or that would affect the investigational product 7. Clinically significant deviation from the reference range in clinical laboratory test results at enrolment as judged by the Investigator. 8. ECG considered to show cardiac abnormality at enrolment as determined by a central reader cardiologist and confirmed by Investigator as clinically significant. 9. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria: - unstable DM defined as enrolment glycosylated Hb >8.5% - admitted to hospital for treatment of DM or DM related illness in the past 12 weeks - not under care of physician responsible for patient’s DM care - 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 - has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks prior to enrolment (Visit 1). For thiazolidinediones (glitazones) this period should not be less than 8 weeks - 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. 10. A thyroid-stimulating hormone (TSH) concentration higher than 10% above the upper limit of the normal range of the laboratory used for sample analysis at enrolment, whether or not the patient is being treated for hypothyroidism. 11. Administration of a depot antipsychotic injection within 1 dosing interval (for the depot) before day of switch (Visit 2). 12. Known intolerance, or lack of response to treatment with quetiapine IR or treatment with quetiapine IR within 4 weeks prior to enrolment. 13. Known lack of response to clozapine or treatment with clozapine within 4 weeks prior to enrolment. 14. Patients who have started treatment within 4 weeks prior to enrolment with potent cytochrome 3A4 inducers or inhibitors that could potentially affect the metabolism of quetiapine (eg, inducers: phenytoin, carbamazepine, pentobarbital, rifampin, rifabutin, glucocorticoids, thioridazine, St. John's Wort. inhibitors: ketoconazole (except for topical use), itraconazole, fluconazole, erythromycin, clarithromycin, nefazodone, troleandomycin, indinavir, nelfinavir, ritonavir, and saquinavir). 15. Participation in another drug study within 4 weeks prior to enrolment into this study, or longer in accordance with local requirements. 16. Previous participation in this study. 17. Involvement in the planning and conduct of the study (applies to AstraZeneca staff, Quintiles staff or staff at the investigational site
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of patients who at Visit 7 (Week 12) have an improved clinical benefit based on assessment of clinical efficacy in combination with assessment of tolerability using the Clinical Global Impression-Clinical Benefit (CGI-CB) score, according to a classification based on the principles outlined in Clinical Global Impression item 3 (CGI item 3). Improvement in clinical benefit is defined as a decrease from baseline in CGI-CB. |
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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 | 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 | No |
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 | 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 | 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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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 | 1 |
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 | 1 |