Efficacy and Safety of Cordyceps militaris as an Adjuvant to Duloxetine in the Treatment of Insomnia in Patients With Depression: A 6-Week Double-Blind, Randomized, Placebo-Controlled Trial

Authors: Jiaojiao Zhou, Xu Chen, Le Xiao, Jingjing Zhou, Lei Feng, and Gang Wang

Journal: Frontiers in Psychiatry

Study Design: Single-center, randomized, double-blind, placebo-controlled trial

59 outpatients diagnosed with major depressive disorder (MDD) with insomnia

Intervention:

• Duloxetine (60 mg/day) plus Cordyceps militaris (3 g/day) for 6 weeks
• Duloxetine (60 mg/day) plus placebo for 6 weeks

Outcome Measures:

• Primary outcome: Mean change in total Athens Insomnia Scale (AIS) score and its subscales
• Secondary outcome: Change in total 17-item Hamilton Depression Scale (HAMD-17) score and its sleep factor score
• Safety assessment: Physical examination, vital signs, adverse events, clinical laboratory tests, and 12-lead electrocardiograms (ECGs)

Summary: The study investigated the efficacy and safety of Cordyceps militaris as an add-on treatment to duloxetine for insomnia in patients with depression. The results showed that Cordyceps militaris did not significantly improve sleep symptoms compared to the placebo. Both groups experienced a reduction in depressive and sleep symptoms over time, likely due to the effect of duloxetine. The study also concluded that Cordyceps militaris was safe and well-tolerated, with no significant difference in adverse events between the two groups.