Efficacy and Safety of Cranial Electrical Stimulation (CES) for Major Depressive Disorder (MDD)

Completed · Not applicable · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT01325532

Run by

Massachusetts General Hospital

People needed

30

Starts

2010-11-01

Expected to finish

2015-01-01

Last updated by the study team

2016-06-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following criteria to participate in the study:
• Age 18-65 years old
• Be in generally good health
• Meet criteria for Major Depressive Disorder based on the DSM-IV
• HAM-D-17 score ≥ 15, and ≤ 23

You may not qualify if…

• Subjects meeting any of the following criteria will not be allowed to participate in the study:
• Taking any antidepressant medications (including natural products such as omega-3, St John's wort, and/or SAMe)
• Having any unstable health conditions (unstable cardiovascular illness, cardiac arrhythmia, presence of a pacemaker, epilepsy and shock, fever, weakness and hypotension, or presence of a vagal nerve stimulator)
• Having any electrical stimulation implants - i.e. pacemaker, deep brain stimulators (VNS, DBS), transcutaneous electrical nerve stimulator (TENS)
• Psychotic or manic symptoms, or other evidence of a psychotic disorder; recent history of substance abuse or dependence
• Electro Convulsive Therapy (ECT) during the last year
• Previous course of Cranial Electrical Stimulation
• Current active suicidal or self-injurious potential necessitating immediate treatment
• In women, pregnancy, plans to conceive, or unwillingness to comply with birth control requirements
• Depression-focused psychotherapy initiated within 90 days preceding enrollment or during participation in study

Where it is running

• Depression Clinical and Research Program at Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.