Schizophrenia
Conditions
Interventions
Trade Name: Serdolect
Product Name: Sertindolum
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: sertindolum
Other descriptive name: serdolect
Concentration unit: mg milligram(s)
Co
Sponsors
Tartu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To primary objective of this study is to investigate the effect of sertindole on cognition in patients with schizophrenia.;Secondary Objective: 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. ;Primary end point(s): | — |
Countries
Estonia
Outcome results
None listed