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

NCT ID: NCT01325532

Last Updated: 2016-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2015-01-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Active CES

Intervention Type: DEVICE

CES current

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.

Group Type: SHAM_COMPARATOR

Sham CES

Intervention Type: DEVICE

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

Interventions

Active CES

CES current

Intervention Type: DEVICE

Sham CES

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

Intervention Type: DEVICE

Other Intervention Names

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

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisher Wallace Labs, LLC

UNKNOWN

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

David Mischoulon, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Mischoulon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Depression Clinical and Research Program at Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 26424428 (View on PubMed)

Other Identifiers

2010 P000461

Identifier Type: -

Identifier Source: org_study_id