- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01325532
Efficacy and Safety of Cranial Electrical Stimulation (CES) for Major Depressive Disorder (MDD)
Efficacy and Safety of Cranial Electrical Stimulation (CES) for the Treatment of Major Depressive Disorder (MDD): A Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Depression Clinical and Research Program at Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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CES current
Other Names:
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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.
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Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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Baseline-Week 3
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Reported Side Effects Based on PRISE AE Scores
Time Frame: Baseline-Week 3
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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.
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Baseline-Week 3
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Global Sleep Scores on the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Week 3.
Time Frame: Baseline-Week 3
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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).
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Baseline-Week 3
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010 P000461
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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