An open-label pilot study of icariin for co-morbid bipolar and alcohol use disorder

Objectives: Bipolar disorder is associated with a very high prevalence of alcohol-related disorders. However, few studies have examined treatment in this population. Preclinical research suggests a role for the flavonoid icariin in mood and addictive disorders. In this open-label pilot study, we investigated the feasibility and safety of using icariin for persons with bipolar disorder and alcohol abuse or dependence. Methods: Ten participants with bipolar I or bipolar II disorders, currently depressed, and with active alcohol abuse or dependence were given open-label icariin of up to 300 mg/day for 8 weeks using a flexible dosing strategy. Participants were assessed using the Hamilton Rating Scale for Depression (HAMD), Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), Hamilton Rating Scale for Anxiety (HAMA), and Young Mania Rating Scale (YMRS). Standard drinks, heavy drinking days, and drinking days were also quantified. Baseline and exit data were analyzed using the Wilcoxon Signed Rank Test. Results: We observed a significant decrease in the HAMD (p = 0.012, d = 0.8), QIDS (p = 0.017, d = 0.7), and HAMA (p = 0.005, d = 1.4) scores. Heavy drinking days (p = 0.034, d = 1.1) and standard drinks (p = 0.038, d = 0.8) also decreased significantly. Icariin was well tolerated and no participants withdrew due to side-effects. Conclusion: Results from this uncontrolled study suggest icariin may decrease depressive symptoms and reduce alcohol consumption in persons with bipolar disorder and alcohol use. Improvement in mood and alcohol use was similar to that observed in an open-label trial of naltrexone in this population. Controlled trials, but at this point not routine clinical use, of icariin seem warranted.