Overview

This trial is active, not recruiting.

Condition major depressive disorder
Treatments cranial electrical stimulation via fw-100 fisher wallace cranial stimulator, ces sham via fw-100 fisher wallace cranial stimulator
Sponsor Massachusetts General Hospital
Collaborator Fisher Wallace Labs, LLC
Start date November 2010
End date January 2015
Trial size 20 participants
Trial identifier NCT01325532, 2010 P000461

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
cranial electrical stimulation via fw-100 fisher wallace cranial stimulator 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.
(Sham Comparator)
ces sham via fw-100 fisher wallace cranial stimulator FW-100 Fisher Wallace Cranial Stimulator
Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks.

Primary Outcomes

Measure
Change in HAM-D 17 score from baseline to visit 15.
time frame: Baseline-Visit 15
Change in PRISE AE scores from baseline to visit 15.
time frame: Baseline-Visit 15

Secondary Outcomes

Measure
Change in sleep scores on the PSQI from baseline to visit 15.
time frame: Baseline-Visit 15

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Efficacy and Safety of Cranial Electrical Stimulation (CES) for the Treatment of Major Depressive Disorder (MDD): A Pilot Study
Principal investigator David Mischoulon, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.