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 primary objective of this study is to investigate the effect of sertindole on cognition in patients with schizophrenia. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are: 1.To evaluate the impact of sertindole treatment on subjective quality of live 2.To evaluate the safety and tolerability profiles 3.To study the effect of serdtindole treatment on the metabolic biochemistry 4.To study the effect of sertindole treatment on the gene expression level in lymphocytes in order to find out whether these possible clinical and molecular alterations are associated with treatment efficacy and cognitive effects.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The study sample will include up to 60 patients with schizophrenia diagnosis according to DSM-IV criteria. Subjects will be recruited amongst the inpatients and outpatients of Psychiatry Clinic of Tartu University, Psychiatric Clinics of Tallinn, Viljandi and Pärnu. Inclusion criteria 1. The patient is able to read and understand the patient information sheet 2. Aged between 18 and 55 years inclusive 3. Male or female patient, 4. Women must be not pregnant and not lactating 5. Schizophrenic patient according to DSM IV-TR diagnosis 6. Patients having diagnosis for at least one year; 7. No abnormal findings of clinical relevance in any of the investigations performed at the screening visit (physical exam, ECG). 8. Patients with at least completed secondary educations 9. Patients must have given written informed consent prior to screening assessments. 10. The score >2 on at least two of the following five BPRS items: conceptual disorganisation (4), suspiciousness (11), hallucinatory behaviour (12), unusual thought content (15) and excitement (17). The sum of these items > 7. 11. Significant cognitive impairment as objectively evaluated by neuropsychologists
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E.4 | Principal exclusion criteria |
Exclusion criteria 1. De novo patients; 2. Significant cardiovascular or ECG abnormality, other contraindications according to national SPC of sertindole; 3. Seizure disorders, severe cerebral trauma, stroke, Parkinson’s disease, dementia, or any other significant neurological illness; 4. Serious risk of suicide evaluated according to the investigator.
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E.5 End points |
E.5.1 | Primary end point(s) | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Yes |
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 | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
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 | 2 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |