Efficacy of cranial electrotherapy stimulation in the treatment of depression: A pilot study

This is a double-blind, placebo-controlled, exploratory study examining the efficacy of Cranial Electrotherapy Stimulation (CES) in the treatment of depression. Twenty participants who met criteria were selected from a rural community. Ten were randomly assigned to the active/experimental group, and 10 were randomly assigned to the placebo/sham group. A pre-test Beck Depression Inventory-II (BDI-II) was administered prior to administration of CES to measure baseline of depressive symptoms. The study protocol consisted of 21 consecutive days of treatment with the participants coming to the Research Center for administration of CES. The devices used in this study were supplied by Electromedical Products International, Inc. (EPI) and were locked at 0.002 amperes with the timer set at 60 minutes. The outcome measure for this study was the self-administered Beck Depression Inventory-II (BDI-II). Following the three-week protocol, the post-test scores on the BDI-II were significantly lower for the active/experimental group when compared to the pre-test scores. Likewise, the post-test scores on the BDI-II were significantly lower for the placebo/sham CES group compared to the pre-test scores. As there was no statistically significant difference between the post-test scores for the active/experimental group versus the placebo/sham CES group, the efficacy of CES cannot be confirmed by the present study. Limitations of the study were small sample size and failure to include a second, untreated group which may have contributed to obscuring the effects of CES that may have been prevalent. Keywords: cranial electrotherapy stimulation, CES, depression, medical device placebo effect