Clinical trial NCT01325532: Efficacy and Safety of Cranial Electrical Stimulation (CES) for Major Depressive Disorder (MDD)
Official title: Efficacy and Safety of Cranial Electrical Stimulation (CES) for the Treatment of Major Depressive Disorder (MDD): A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: depression
Major Depressive Disorder
MDD
Cranial Electrical Stimulation
CES
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Fisher Wallace Labs, LLC
First posted: 2011-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: We examined efficacy and safety of one specific cranial electrical stimulator (CES) device at a fixed setting in subjects with treatment-resistant major depressive disorder (MDD). Thirty subjects with MDD and inadequate response to standard antidepressants were randomized to 3 weeks of treatment with CES (15/500/15000 Hz, symmetrical rectangular biphasic current of 1-4 mAmp, 40 Volts) or sham CES (device off) for 20 minutes, 5 days per week. The primary outcome measure was improvement in the 17-item Hamilton Depression Rating Scale (HAM-D-17). Adverse effects (AEs) were assessed using the Patient Related Inventory of Side Effects (PRISE). We hypothesized that subjects who received active as opposed to sham CES would have a significantly greater improvement in their depression symptoms. Due to the small sample, we could not hypothesize an effect size, but would calculate one to determine signal strength to guide the design of a larger, more rigorous study. As an exploratory aim, we also examined whether CES would benefit sleep.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hamilton Depression Rating Scale (HAM-D 17) Score From Baseline to Week 3
timeFrame: Baseline-Week 3
measure: Reported Side Effects Based on PRISE AE Scores
timeFrame: Baseline-Week 3
Secondary outcomes:
measure: Change in Global Sleep Scores on the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Week 3.
timeFrame: Baseline-Week 3
Other outcomes:
Locations:
city: Boston
country: United States
facility: Depression Clinical and Research Program at Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: David Mischoulon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mischoulon D, De Jong MF, Vitolo OV, Cusin C, Dording CM, Yeung AS, Durham K, Parkin SR, Fava M, Dougherty DD. Efficacy and safety of a form of cranial electrical stimulation (CES) as an add-on intervention for treatment-resistant major depressive disorder: A three week double blind pilot study. J Psychiatr Res. 2015 Nov;70:98-105. doi: 10.1016/j.jpsychires.2015.08.016. Epub 2015 Aug 29.