Randomized placebo controlled trial of cyproheptadine for prevention of neuropsychiatric adverse effects of antiretroviral including efavirenz.

Introduction
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.
Methods
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.
Results
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.
Conclusions
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.