Efficacy and Safety of Cranial Electrical Stimulation (CES) for Major Depressive Disorder (MDD)
| Status: | Completed |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/23/2013 |
| Start Date: | November 2010 |
| End Date: | November 2013 |
| Contact: | Kelley Durham, BA |
| Email: | kedurham@partners.org |
| Phone: | 617-724-2936 |
Efficacy and Safety of Cranial Electrical Stimulation (CES) for the Treatment of Major Depressive Disorder (MDD): A Pilot Study
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.
Inclusion Criteria
Subjects must meet all of the following criteria to participate in the study:
1. Age 18-65 years old
2. Be in generally good health
3. Meet criteria for Major Depressive Disorder based on the DSM-IV
4. HAM-D-17 score ≥ 15, and ≤ 23
Exclusion Criteria
Subjects meeting any of the following criteria will not be allowed to participate in the
study:
1. Taking any antidepressant medications (including natural products such as omega-3, St
John's wort, and/or SAMe)
2. 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)
3. Having any electrical stimulation implants - i.e. pacemaker, deep brain stimulators
(VNS, DBS), transcutaneous electrical nerve stimulator (TENS)
4. Psychotic or manic symptoms, or other evidence of a psychotic disorder; recent
history of substance abuse or dependence
5. Electro Convulsive Therapy (ECT) during the last year
6. Previous course of Cranial Electrical Stimulation
7. Current active suicidal or self-injurious potential necessitating immediate treatment
8. In women, pregnancy, plans to conceive, or unwillingness to comply with birth control
requirements
9. Depression-focused psychotherapy initiated within 90 days preceding enrollment or
during participation in study
We found this trial at
1
site
Boston, Massachusetts 02114
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