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

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ClinicalTrials.gov Identifier: NCT01325532
Recruitment Status : Completed
First Posted : March 29, 2011
Results First Posted : June 1, 2016
Last Update Posted : June 1, 2016
Sponsor:
Collaborator:
Fisher Wallace Labs, LLC
Information provided by (Responsible Party):
David Mischoulon, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE March 24, 2011
First Posted Date  ICMJE March 29, 2011
Results First Submitted Date  ICMJE March 20, 2016
Results First Posted Date  ICMJE June 1, 2016
Last Update Posted Date June 1, 2016
Study Start Date  ICMJE November 2010
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2016)
  • Change in Hamilton Depression Rating Scale (HAM-D 17) Score From Baseline to Week 3 [ Time Frame: Baseline-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).
  • Reported Side Effects Based on PRISE AE Scores [ Time Frame: Baseline-Week 3 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2011)
  • Change in HAM-D 17 score from baseline to visit 15. [ Time Frame: Baseline-Visit 15 ]
    This will measure the improvement in depressive symptoms during the course of treatment.
  • Change in PRISE AE scores from baseline to visit 15. [ Time Frame: Baseline-Visit 15 ]
    This will measure the presence of different adverse (side) effects from treatment during the study.
Change History Complete list of historical versions of study NCT01325532 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2016)
Change in Global Sleep Scores on the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Week 3. [ Time Frame: Baseline-Week 3 ]
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2011)
Change in sleep scores on the PSQI from baseline to visit 15. [ Time Frame: Baseline-Visit 15 ]
This is a patient-rated instrument to assess sleep quality and quantity and its changes throughout the study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Cranial Electrical Stimulation (CES) for Major Depressive Disorder (MDD)
Official Title  ICMJE Efficacy and Safety of Cranial Electrical Stimulation (CES) for the Treatment of Major Depressive Disorder (MDD): A Pilot Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Device: Active CES
    CES current
    Other Names:
    • FW-100 Fisher Wallace Cranial Stimulator
    • Formerly known as: Liss Cranial Stimulator Model SBL202-B
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: Active CES
  • 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.
    Intervention: Device: Sham CES
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2016)
30
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2011)
20
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01325532
Other Study ID Numbers  ICMJE 2010 P000461
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Mischoulon, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Fisher Wallace Labs, LLC
Investigators  ICMJE
Principal Investigator: David Mischoulon, MD, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP