NCT03222752

Efficacy of Cranial Electrotherapy Stimulation (CES) for the Treatment of Major Depressive Disorder

A 6 Week, Randomized, Double-blind, Placebo Controlled Trial of the Efficacy and Tolerability of Cranial Electrotherapy Stimulation for the Treatment of Major Depressive Disorder, With a 6 Week Open Label Extension Phase.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Electromedical Products International, Inc. · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Efficacy of Cranial Electrotherapy Stimulation (CES) for the treatment of Major Depressive Disorder

Detailed description

A 6 week, randomized, double-blind, placebo controlled trial of the efficacy and tolerability of Cranial Electrotherapy Stimulation for the treatment of Major Depressive Disorder, with a 6 week open label extension phase.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Cranial Electrotherapy Stimulation	Alpha-Stim® AID microcurrent and cranial electrotherapy stimulator will be used. Daily one hour cranial electrotherapy stimulation (CES) treatment using ear clip electrodes with current set at fixed level of 100 uA (a subsensory current level), 0.5 Hertz will be used for active CES treatment group for 6 weeks. For the sham group the Alpha-Stim® AID ear clips will not emit electricity.
DEVICE	Sham Cranial Electrotherapy Stimulation	The sham treatment will be using a sham Alpha-Stim AID which will look and sound exactly like the active treatment but will deliver no current.

Timeline

• Start date: 2017-06-05
• Primary completion: 2023-04-25
• Completion: 2023-04-25
• First posted: 2017-07-19
• Last updated: 2023-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study