A Pilot Study of Safety and Efficacy of Cranial Electrotherapy Stimulation in Treatment of Bipolar II Depression

Deimante McClure, Samantha C Greenman, Siva Sundeep Koppolu, Maria Varvara, Zimri S Yaseen, Igor I Galynker, Deimante McClure, Samantha C Greenman, Siva Sundeep Koppolu, Maria Varvara, Zimri S Yaseen, Igor I Galynker

Abstract

This double-blind, sham-controlled study sought to investigate the effectiveness of cranial electrotherapy stimulation (CES) for the treatment of bipolar II depression (BD II). After randomization, the active group participants (n = 7) received 2 mA CES treatment for 20 minutes five days a week for 2 weeks, whereas the sham group (n = 9) had the CES device turned on and off. Symptom non-remitters from both groups received an additional 2 weeks of open-label active treatment. Active CES treatment but not sham treatment was associated with a significant decrease in the Beck Depression Inventory (BDI) scores from baseline to the second week (p = 0.003) maintaining significance until week 4 (p = 0.002). There was no difference between the groups in side effects frequency. The results of this small study indicate that CES may be a safe and effective treatment for BD II suggesting that further studies on safety and efficacy of CES may be warranted.

Trial registration: ClinicalTrials.gov NCT01909011.

Figures

FIGURE 1
FIGURE 1
Change in BDI scores from baseline to week 1 and week 2.
FIGURE 2
FIGURE 2
Change in Q-LES-Q scores from baseline to week 1 and week 2.
FIGURE 3
FIGURE 3
Change in HAM-D scores from baseline to week 1 and week 2.
FIGURE 4
FIGURE 4
Change in CGI-S scores from baseline to week 1 and week 2.
FIGURE 5
FIGURE 5
Change in YMRS scores from baseline to week 1 and week 2.

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