Back to resultsEfficacy and Safety of Cranial Electrical Stimulation (CES) for Major Depressive Disorder (MDD)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active CES
Sham CES
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, Major Depressive Disorder, MDD, Cranial Electrical Stimulation, CES
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
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
Sites / Locations
- Depression Clinical and Research Program at Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active CES
Sham CES
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Change in Global Sleep Scores on the Pittsburgh Sleep Quality Index (PSQI) From Baseline to 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).
Full Information
NCT ID
NCT01325532
First Posted
March 24, 2011
Last Updated
April 23, 2016
Sponsor
Massachusetts General Hospital
Collaborators
Fisher Wallace Labs, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01325532
Brief Title
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
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Fisher Wallace Labs, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, Major Depressive Disorder, MDD, Cranial Electrical Stimulation, CES
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active CES
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham CES
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Active CES
Other Intervention Name(s)
FW-100 Fisher Wallace Cranial Stimulator, Formerly known as: Liss Cranial Stimulator Model SBL202-B
Intervention Description
CES current
Intervention Type
Device
Intervention Name(s)
Sham CES
Other Intervention Name(s)
FW-100 Fisher Wallace Cranial Stimulator (sham setting), Formerly known as: Liss Cranial Stimulator Model SBL202-B
Intervention Description
Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks.
Primary Outcome Measure Information:
Title
Change in Hamilton Depression Rating Scale (HAM-D 17) Score From Baseline to Week 3
Description
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).
Time Frame
Baseline-Week 3
Title
Reported Side Effects Based on PRISE AE Scores
Description
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.
Time Frame
Baseline-Week 3
Secondary Outcome Measure Information:
Title
Change in Global Sleep Scores on the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Week 3.
Description
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).
Time Frame
Baseline-Week 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mischoulon, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Depression Clinical and Research Program at Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26424428
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.
Results Reference
result
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Efficacy and Safety of Cranial Electrical Stimulation (CES) for Major Depressive Disorder (MDD)
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