Authors
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[No authors listed]
Category
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Primary study
Registry of Trials»Iranian Registry of Clinical Trials
Year
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2009
INTERVENTION: 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). 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). 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). Prevention CONDITION: F20, F25, Schizophrenia ,Schizoaffective disorders ,Bipolar affective disorder schizophrenia, bipolar mood disorder, schizoaffective. ; Schizophrenia ,Schizoaffective disorders ,Bipolar affective disorder PRIMARY OUTCOME: Blood pressure. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Mercury sphygmomanometer. 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. FBS. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Enzymatic procedure. Height. Timepoint: at the beginning of the study. Method of measurement: standard methods. 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. Waist circumference. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: measuring tape. Weight. Timepoint: at the beginning of the study and 6 weeks after intervention. Method of measurement: digital scale. INCLUSION CRITERIA: 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 cho SECONDARY OUTCOME: CRP‐hs. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Immunoturbidimetry. Fasting Insulin. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Chemiluminescence. Fibrinogen. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Clauss Coagulation method. 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. LDL. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Enzymatic assays (Directly measured). Lipoprotein (a). Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Immunoturbidimetry. 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. Total cholesterol. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Enzymatic assays. 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).
Epistemonikos ID: 5f332be502c51927b107b5ee2f60b8b349b156e2
First added on: Aug 22, 2024