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Completed

NCT Number: NCT01325532

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

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Depression Clinical and Research Program at Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active CES

Device

CES current

Other names: FW-100 Fisher Wallace Cranial Stimulator, Formerly known as: Liss Cranial Stimulator Model SBL202-B

Sham CES

Device

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

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Fisher Wallace Labs, LLC

Registry information

Official study title

Efficacy and Safety of Cranial Electrical Stimulation (CES) for the Treatment of Major Depressive Disorder (MDD): A Pilot Study

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Mar 29, 2011
Registry last updated
Jun 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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