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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fisher Wallace Labs, LLC
Information provided by (Responsible Party):
David Mischoulon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01325532
First received: March 24, 2011
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Device: Cranial Electrical Stimulation via FW-100 Fisher Wallace Cranial Stimulator
Device: CES Sham via FW-100 Fisher Wallace Cranial Stimulator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Cranial Electrical Stimulation (CES) for the Treatment of Major Depressive Disorder (MDD): A Pilot Study

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in HAM-D 17 score from baseline to visit 15. [ Time Frame: Baseline-Visit 15 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    This will measure the presence of different adverse (side) effects from treatment during the study.


Secondary Outcome Measures:
  • Change in sleep scores on the PSQI from baseline to visit 15. [ Time Frame: Baseline-Visit 15 ] [ Designated as safety issue: No ]
    This is a patient-rated instrument to assess sleep quality and quantity and its changes throughout the study.


Estimated Enrollment: 20
Study Start Date: November 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active CES Device: Cranial Electrical Stimulation via FW-100 Fisher Wallace Cranial Stimulator
CES current - 100Hz, symmetrical rectangular biphasic, 20% duty cycle current for 20-minutes, 5 days/week for 3 weeks.
Other Names:
  • FW-100 Fisher Wallace Cranial Stimulator
  • Formerly known as: Liss Cranial Stimulator Model SBL202-B
Sham Comparator: Sham CES Device: CES Sham via FW-100 Fisher Wallace Cranial Stimulator
Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks.
Other Names:
  • FW-100 Fisher Wallace Cranial Stimulator
  • Formerly known as: Liss Cranial Stimulator Model SBL202-B

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325532

Locations
United States, Massachusetts
Depression Clinical and Research Program at Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Fisher Wallace Labs, LLC
Investigators
Principal Investigator: David Mischoulon, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: David Mischoulon, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01325532     History of Changes
Other Study ID Numbers: 2010 P000461
Study First Received: March 24, 2011
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
depression
Major Depressive Disorder
MDD
Cranial Electrical Stimulation
CES

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 19, 2014