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IRCT201103106026N1 IRCT 2011-05-01 Vice-Chancellor for Research,Tehran University of Medical Sciences and Health Services Cyproheptadine for prevention of neuropsychiatric adverse effects of antiretrovirals including efavirenz Randomized placebo controlled trial of cyproheptadine for prevention of neuropsychiatric adverse effects of antiretroviral including efavirenz. 2011-11-21 anticipated 50 Complete https://irct.ir/trial/6486 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Human immunodeficiency virus [HIV] disease. Intervention 1: Interventional group: cyproheptadine, oral tablet 4 mg, 2 tablets at night for 1 week.cyproheptadine, oral tablet 4 mg, 3 tablets at night for other 3 weeks. Intervention 2: Control group: cyproheptadine placebo, oral tablet 4 mg, 2 tablets at night for 1 week.cyproheptadine placebo, oral tablet 4 mg, 3 tablets at night for other 3 weeks. http://online.liebertpub.com/doi/abs/10.1089/apc.2012.0410 Introduction<br /> Efavirenz is backbone of antiretroviral therapy regime. Efavirenz caused neuropsychiatric adverse effects with 50% prevalence. Limited studies showed the efficacy of cyproheptadine in psychiatric disorders (such as anxiety, depression, nightmares and schizophrenia), headache, increasing appetite and weight gain. In present study we investigate the effects of cyproheptadine on prevention of neuropsychiatric adverse effects during the first month of initiating antiretroviral regime including efavirenz. <br /> Methods <br /> This study was a double-blind randomized clinical trial of 51 HIV positive outpatients. Cyproheptadine 8 mg per day was administered for one week and 12 mg per day for other 3 weeks in interventional group and patients took placebo with the same dose and frequency in control group. Neuropsychiatric adverse effects were evaluated with, Hamilton Depression Rating scale, Hamilton Anxiety Rating Scale, Positive and Negative Syndrome Scale, Beck Depression Inventory-2nd Edition, Pittsburgh Sleep Quality Inventory, Positive and Negative Suicide Ideation and Somatization subscale of Symptom Checklist 90 on day 0 and 28 after treatment. <br /> Results<br /> Cyproheptadine decreased the scores of 6 scales (Hamilton Depression Rating scale, Hamilton Anxiety Rating Scale, Positive and Negative Syndrome Scale, Beck Depression Inventory-2nd Edition, Pittsburgh Sleep Quality Inventory, Positive and Negative Suicide Ideation and Somatization subscale of Symptom Checklist 90) after 1 month in the intervention group. The scores of all scales and also weight were increased after 1 month in the placebo group.<br /> Conclusions <br /> Cyproheptadine can prevent many neuropsychiatric adverse effects that are related to efavirenz. Further studies with larger number of patients are needed to confirm the results of our results.<br />
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scientific Hossein Khalili
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences and Health Services, Enghelab Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 6695 4715 khalilih@sina.tums.ac.ir Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences and Heal Iran (Islamic Republic of) Inclusion criteria: Patients with HIV-1 infection, older than 18 years who are scheduled to receive an efavirenz-containing treatment Exclusion criteria: Pervious treatment with antiretroviral drugs including efavirenz, pregnancy, use of other medications that be effective on patient‘s mood such as methadone and having major psychiatric disorders like depression at the beginning of this study. 18 years 55 years Both B23 Human immunodeficiency virus [HIV] disease resulting in other conditions Treatment - Drugs Placebo Interventional group: cyproheptadine, oral tablet 4 mg, 2 tablets at night for 1 week.cyproheptadine, oral tablet 4 mg, 3 tablets at night for other 3 weeks Control group: cyproheptadine placebo, oral tablet 4 mg, 2 tablets at night for 1 week.cyproheptadine placebo, oral tablet 4 mg, 3 tablets at night for other 3 weeks Neuropsychiatric effects of efavirenz. Timepoint: Before intevention, 4 weeks after intervention. Method of measurement: Questionnaire. Appetite. Timepoint: Before intevention, 4 weeks after intervention. Method of measurement: Questionnaire. Weight. Timepoint: Before intevention, 4 weeks after intervention. Method of measurement: Weight scale. Vice-Chancellor for Research,Tehran University of Medical Sciences and Health Services Approved 2011-01-18 Tehran University of Medical Sciences and Health Services Tehran University of Medical Sciences and Health Services, Enghelab ave, Tehran, Iran Tehran Iran (Islamic Republic of)