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IRCT201410073449N17 IRCT 2014-10-19 Vice Chancellor for Research, Tehran University of Medical Sciences Effect of Omega-3 on depression of HIV/AIDS patients Comparing efficacy of Omega-3 and placebo in reducing beck depression score in HIV/AIDS patients 2015-01-01 anticipated 100 Complete https://irct.ir/trial/3550 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Included patients will be assigned to the Omeag-3 or Placebo group based on the block randomization method. Randomization and distribution of the omega-3 or placebo will be done by the hospital pharmacy department and researchers, physicians and patients will be blinded regarding type of intervention (Omega-3 or placebo). 3 Depression. Intervention 1: Soft gelatin Cap of omega-3 (Cap 1000 mg, Zahravi Pharmaceutical Company, Tabriz, Iran), One Cap orally twice daily, for 8 weeks. Intervention 2: Soft gelatin Cap of Placebo (Cap 1000mg, Zahravi Pharmaceutical Company, Tabriz, Iran), One Cap orally twice daily, for 8 weeks.
public
scientific Hossein Khalili
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) +98 21 6658 1598 khalilih@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: HIV positive patients with age between 18-65 years old, received antiretroviral therapy for at-least one years, CD4 count≥350 and Beck Depression Score (BDS)≥16. Exclusion criteria: HIV positive patients suffering from other psychological disorders, major depression with recent suicidal attempt, history of drugs or alcohol abuse, other concomitant severe medical diseases such as diabetes mellitus, intake of omega-3 during last 3 months, sensitivity to omega-3, coagulation disorders or intake of anticoagulants and receiving any drugs that affect patients’ mood including anti-depressants. 18 years 65 years Both F32 In typical mild, moderate, or severe depressive episodes, the patient suffers from lowering of mood, reduction of energy, and decrease in activity. Treatment - Drugs Placebo Soft gelatin Cap of omega-3 (Cap 1000 mg, Zahravi Pharmaceutical Company, Tabriz, Iran), One Cap orally twice daily, for 8 weeks Soft gelatin Cap of Placebo (Cap 1000mg, Zahravi Pharmaceutical Company, Tabriz, Iran), One Cap orally twice daily, for 8 weeks. Beck depression score. Timepoint: at baseline, weeks 4 and 8. Method of measurement: Beck Depression Questionnaire. Vice Chancellor for Research, Tehran University of Medical Sciences Approved 2014-04-29 Ethics Committee of Tehran University of Medical Sciences Ghods Ave. Tehran Iran (Islamic Republic of)