CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Active CES +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01325532
NCT01325532N/ACompleted
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Efficacy and Safety of Cranial Electrical Stimulation (CES) for the Treatment of Major Depressive Disorder (MDD): A Pilot Study

Massachusetts General Hospital·interventional·Posted Mar 29, 2011·Updated Jun 1, 2016

In Brief

A clinical study evaluating Active CES and Sham CES for Major Depressive Disorder. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this study is to see if using Cranial Electrical Stimulation (CES) helps improve symptoms of major depressive disorder (MDD). The investigators are studying the device's effectiveness in treating depression, as well as its safety. This is a pilot study. Eligible participants will be randomly assigned to receive either active CES or sham CES, every weekday for 3 weeks. During the visits, subjects will receive CES or sham CES treatment for 20 minutes. The primary outcome measure will be change in score on the HAM-D 17. The secondary outcome measure will be change in patient-reported sleep score.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
CollaboratorsFisher Wallace Labs, LLC

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 29, 2011
Enrollment StartNov 1, 2010
Primary CompletionJan 1, 2014
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 15.3 years ago

Interventions

Active CESdevice

CES current

Sham CESdevice

Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks.