Efficacy of vitamin E and omega-3 unsaturated fatty acid in prevention of damage induced by oxidative stress in patients with schizophrenia

Conditions: Patients diagnosed with schizophrenia chronically treated with depo haloperidol will be randomly assigned to four arms
i) placebo, ii) vitamin E (1200 IU/day), iii) omega-3 (360 mg/day EPA, 240 mg/day DHA) and iv) vitamin E (1200 IU/day) + omega-3(360 mg/day EPA, 240 mg/day DHA)
MedDRA version: 12.1Level: LLTClassification code 10039626Term: Schizophrenia

Registration Number: EUCTR2009-018054-33-SI

Lead Sponsor: Faculty of Pharmacy, University of Ljubljana

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

Disturbed blood coagulation
Treatment with anticoagulants or vitamin K
Diabetes mellitus
Rheumatoid or psoriatic arthritis
Pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the clinical effects of vitamin E and polyunsaturated fatty acids in patients with schizophrenia treated with depo haloperidol.<br><br>;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.<br>Genetic polymorphism of MnSOD, GSHPx, eNOS, CYP2D6 genes will be investigated. <br>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

Secondary Outcome Measures