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IRCT138712231764N1 IRCT 2009-05-26 Tehran University of Medical Sciences omega 3 and metabolic syndrome Effect of omega-3 fatty acids on the components of metabolic syndrome in schizophrenic, bipolar and schizoaffective patients taking olanzapine plus sodium valproate or olanzapine plus lithium. 2008-06-21 anticipated 50 Complete https://irct.ir/trial/1312 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. 2-3 schizophrenia, bipolar mood disorder, schizoaffective. Intervention 1: Intervention: omega 3 capsules 1000 mg ( containing 300 mg EPA/DHA). 1 capsule/day in the first intervention week, 2 capsules/day (divided) in the second intervention week and 3 capsules/day (divided) from the third intervention week till the end of intervention (end of week 6). Intervention 2: Control: placebo, 1 capsule/day in the first intervention week, 2 capsules/day (divided) in the second intervention week and 3 capsules/day (divided) from the third intervention week till the end of intervention (end of week 6).
public Dr. T. Faghihi
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Enqelab st.
Tehran Iran (Islamic Republic of) +98 21 6695 4709 tfaghihi@razi.tums.ac.ir Tehran University of Medical Sciences scientific Dr. T. Faghihi
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Enqelab st
Tehran Iran (Islamic Republic of) +98 21 6695 4709 tfaghihi@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: psychiatric patients taking olanzapine plus sodium valproate or olanzapine plus lithium with clinical diagnosis of schizophrenia, bipolar mood disorder, schizoaffective disorder, ages between 18-60 yrs. Exclusion criteria: 1- Previous treatment with study drugs (olanzapine, sodium valproate, lithium) during the three months prior to trial initiation/participation, 2- Having a significant active medical problem or abnormal lab tests before initiation of trial including: Liver function tests≥ 3 normal , Thyroid stimulating hormone > 4.2 m.I.U/L, GFR< 60 ml/min, FBS> 125 mg/dl, TG ≥ 500 mg/dl , TG between 200-500 and Non-HDL cholesterol greater than or equal to 30+ target LDL: in cases of TG between 200-500, first Non-HDL cholesterol is calculated. Then the goal LDL of the patient is assessed according to NCEP ATP III LDL goals. Participants with TG between 200-500 are excluded if their Non-HDL cholesterol is greater than or equal to 30 + target LDL. 3- Pregnancy and lactation 4-Recent (within 4 weeks) consumption of omega 3 fatty acids 5-BMI ≥ 30 6-Contraindications for the study drugs 7-Patients or their family refusal to participation 8-Taking Drugs much affecting study parameters. 18 years 60 years Both F20, F25, Schizophrenia ,Schizoaffective disorders ,Bipolar affective disorder Prevention Intervention: omega 3 capsules 1000 mg ( containing 300 mg EPA/DHA). 1 capsule/day in the first intervention week, 2 capsules/day (divided) in the second intervention week and 3 capsules/day (divided) from the third intervention week till the end of intervention (end of week 6). Control: placebo, 1 capsule/day in the first intervention week, 2 capsules/day (divided) in the second intervention week and 3 capsules/day (divided) from the third intervention week till the end of intervention (end of week 6). Weight. Timepoint: at the beginning of the study and 6 weeks after intervention. Method of measurement: digital scale. Height. Timepoint: at the beginning of the study. Method of measurement: standard methods. BMI. Timepoint: at the beginning of the study and 6 weeks after intervention. Method of measurement: Calculated as body weight (kg) divided by the height in meters squared. Waist circumference. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: measuring tape. Blood pressure. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Mercury sphygmomanometer. FBS. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Enzymatic procedure. High-density lipoprotein (HDL). Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Enzymatic procedure. TG. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Enzymatic procedure. Total cholesterol. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Enzymatic assays. LDL. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Enzymatic assays (Directly measured). VLDL. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Calculated using the formula: TC (total cholesterol)- (HDL+ LDL). Non-HDL cholesterol. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Calculated by the formula: Total cholesterol- HDL-c. Fasting Insulin. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Chemiluminescence. Hgb A1C. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Immunoturbidimetry. HOMA-IR. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Calculated. Lipoprotein (a). Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Immunoturbidimetry. Fibrinogen. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Clauss Coagulation method. CRP-hs. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Immunoturbidimetry. Tehran University of Medical Sciences Approved 2008-11-12 Tehran University of Medical Sciences Tehran University of Medical Sciences, Keshavarz Blv Tehran Iran (Islamic Republic of)