Patients diagnosed with schizophrenia chronically treated with depo haloperidol will be randomly assigned to four arms
Conditions
Interventions
Trade Name: Apozema Vitamin E 600 I.E. Kapseln
Product Name: Apozema Vitamin E 600 I.E.
Pharmaceutical Form: Capsule, soft
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of
Sponsors
Faculty of Pharmacy, University of Ljubljana
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with schizophrenia, according to DSM IV classification Patients treated with depo haloperidol Male and female voluntaries over 18 years of age Healthy, other than primary disease, according to the medical history, ECG, laboratory results and physical examination as determined by Principal Investigator/Sub-Investigator. Able to comprehend and be informed of the nature of the study. Capable of giving written informed consent prior to receiving any study medication. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Disturbed blood coagulation Treatment with anticoagulants or vitamin K Diabetes mellitus Rheumatoid or psoriatic arthritis Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the clinical effects of vitamin E and polyunsaturated fatty acids in patients with schizophrenia treated with depo haloperidol. ;Secondary Objective: Oxidative status will be assessed by measuring GSH-px, GSH-red, SOD, CAT, NO2/NO3, XO, MDA, GSH/GSSG in venous blood samples. Genetic polymorphism of MnSOD, GSHPx, eNOS, CYP2D6 genes will be investigated. Role of oxidative stress in possitive and negative symptoms in schizophrenia and pharmacokinetics of haloperidol in shizophrenia, will be established.;Primary end point(s): PANSS, BARS, AIMS, S-ARS, CGI | — |
Countries
Slovenia
Outcome results
None listed