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

This study has been completed.
Sponsor:
Collaborator:
Fisher Wallace Labs, LLC
Information provided by (Responsible Party):
David Mischoulon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01325532
First received: March 24, 2011
Last updated: April 23, 2016
Last verified: April 2016
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Device: Active CES
Device: Sham CES

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Cranial Electrical Stimulation (CES) for the Treatment of Major Depressive Disorder (MDD): A Pilot Study

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in Hamilton Depression Rating Scale (HAM-D 17) Score From Baseline to Week 3 [ Time Frame: Baseline-Week 3 ] [ Designated as safety issue: No ]
    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).

  • Reported Side Effects Based on PRISE AE Scores [ Time Frame: Baseline-Week 3 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Change in Global Sleep Scores on the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Week 3. [ Time Frame: Baseline-Week 3 ] [ Designated as safety issue: No ]
    The Pittsburgh Sleep Quality Index (PSQI) is a patient-rated instrument to assess sleep quality and quantity and its changes throughout the study. Scoring is based on 7 individual components. Each component is scored from 0-3. Higher scores indicate worse sleep. Total global sleep score ranges from zero (0) to 21. We report here the overall change in global sleep score for each treatment arm, 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 sleep disturbance (improvement), whereas a score of less than zero indicates an increase in sleep disturbance (worsening).


Enrollment: 30
Study Start Date: November 2010
Study Completion Date: January 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active CES
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
CES current
Other Names:
  • FW-100 Fisher Wallace Cranial Stimulator
  • Formerly known as: Liss Cranial Stimulator Model SBL202-B
Sham Comparator: Sham CES
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
Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks.
Other Names:
  • FW-100 Fisher Wallace Cranial Stimulator (sham setting)
  • Formerly known as: Liss Cranial Stimulator Model SBL202-B

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325532

Locations
United States, Massachusetts
Depression Clinical and Research Program at Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Fisher Wallace Labs, LLC
Investigators
Principal Investigator: David Mischoulon, MD, PhD Massachusetts General Hospital
  More Information

Publications:
Responsible Party: David Mischoulon, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01325532     History of Changes
Other Study ID Numbers: 2010 P000461 
Study First Received: March 24, 2011
Results First Received: March 20, 2016
Last Updated: April 23, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Massachusetts General Hospital:
depression
Major Depressive Disorder
MDD
Cranial Electrical Stimulation
CES

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on December 08, 2016