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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01325532
• Other study ID #: 2010 P000461
• Status: Active, not recruiting
• Phase: N/A
• First received: March 24, 2011
• Last updated: April 6, 2015
• Start date: November 2010
• Est. completion date: November 2015

Study information

• Verified date: April 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: November 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.
• CES Sham via FW-100 Fisher Wallace Cranial Stimulator
Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks.

Locations

Country	Name	City	State
United States	Depression Clinical and Research Program at Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Fisher Wallace Labs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HAM-D 17 score from baseline to visit 15.	This will measure the improvement in depressive symptoms during the course of treatment.	Baseline-Visit 15	No
Primary	Change in PRISE AE scores from baseline to visit 15.	This will measure the presence of different adverse (side) effects from treatment during the study.	Baseline-Visit 15	Yes
Secondary	Change in sleep scores on the PSQI from baseline to visit 15.	This is a patient-rated instrument to assess sleep quality and quantity and its changes throughout the study.	Baseline-Visit 15	No