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

NCT01325532 | Completed Results DMC

• 1 other identifier: 2010 P000461
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

depression; Major Depressive Disorder; MDD; Cranial Electrical Stimulation; CES

Outcome Measures

Primary Outcomes (2)

• Change in Hamilton Depression Rating Scale (HAM-D 17) Score From Baseline to Week 3

  The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52. This section reports the improvement in depressive symptoms during the course of treatment, i.e. the change in overall score between baseline visit and week 3 visit. Change can occur in either direction (i.e. improvement or worsening). A score of greater than zero indicates a reduction of depressive symptoms (improvement), whereas a score of less than zero indicates an increase in depressive symptoms (worsening).

  Baseline-Week 3

• Reported Side Effects Based on PRISE AE Scores

  This measures the emergence of different adverse (side) effects from treatment during the study. This section will describe the most commonly reported adverse effects. The section on adverse events will describe and detail the full range of AEs reported.

  Baseline-Week 3

Secondary Outcomes (1)

• Change in Global Sleep Scores on the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Week 3.

  Baseline-Week 3

Study Arms (2)

Active CES

EXPERIMENTAL

Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of "on" and 16.7msec of "off" time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the "on" time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and "off" time is followed by an opposite negative burst and "off" time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.

Device: Active CES

Sham CES

SHAM COMPARATOR

Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device's green and yellow amperage lights still light up, protecting the blind.

Device: Sham CES

Interventions

Active CES DEVICE

CES current

Also known as: FW-100 Fisher Wallace Cranial Stimulator, Formerly known as: Liss Cranial Stimulator Model SBL202-B

Active CES

Sham CES DEVICE

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

Also known as: FW-100 Fisher Wallace Cranial Stimulator (sham setting), Formerly known as: Liss Cranial Stimulator Model SBL202-B

Sham CES

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Fisher Wallace Labs, LLC: collaborator

Study Sites (1)

Depression Clinical and Research Program at Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 26424428 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

The main limitations include a small sample and lack of an active comparator. Because CES did not separate from its sham counterpart in this sample of MDD patients, we cannot rule out that the benefit obtained from CES was due to placebo effects.

Results Point of Contact

• Title: Dr David Mischoulon
• Organization: Massachusetts General Hospital, Dept of Psychiatry

dmischoulon@partners.org

617-724-5198

Study Officials

• David Mischoulon, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 29, 2011
• Study Start: November 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: June 1, 2016
• Results First Posted: June 1, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)