E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
schizophrenia using the Structured Clinical Interview for Diagnosis (SCID) for the Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV); |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10037175 |
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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 objective of the present study is to identify possible predictors of clinical response to treatment with quetiapine XR in patients with schizophrenia |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate the improvements in cognitive symptoms (working memory, episodic memory and attention) as well as patterns of cortical activation during working memory and episodic memory after quetiapine XR treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
2. Diagnosis of schizophrenia using the Structured Clinical Interview for Diagnosis (SCID) for the Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV); 3. Male or female patients aged between 18 and 65 years; 4. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment; 5. Able to understand and comply with the requirements of the study. 6. Patients with a cut off value for PANSS more than 75. |
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E.4 | Principal exclusion criteria |
1. Pregnancy or lactation; 2. Any DSM-IV Axis I disorder not defined in the inclusion criteria; 3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others; 4. Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator; 5. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir;6. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids; 7. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization; 8. Patients treated with clozapine within 28 days before the enrolment; 9. Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria; 10. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment; 11. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment; 12. Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator; 13. Involvement in the planning and conduct of the study; 14. Previous enrollment or randomization of treatment in the present study; 15. Participation in another drug trial within 4 weeks prior to enrollment into this study or longer in accordance with local requirements; 16. A patient with Diabetes Mellitus (DM) |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary measure of efficacy will be the change from baseline in clinical symptoms assessed by PANSS scores measures based on BDNF genotype in schizophrenic patients after quetiapine XR treatment. |
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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 | No |
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 | Yes |
E.6.11 | Pharmacogenomic | Yes |
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) | No |
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 | No |
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) | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |