N/A
Completed N=30
Efficacy and Safety of Cranial Electrical Stimulation (CES) for Major Depressive Disorder (MDD)
Source: ClinicalTrials.gov NCT01325532 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: Change in Hamilton Depression Rating Scale (HAM-D 17) Score From Baseline to Week 3 — 14.8; 13.6 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hamilton Depression Rating Scale (HAM-D 17) Score From Baseline to Week 3 |
14.8; 13.6 | — |
| PRIMARY Reported Side Effects Based on PRISE AE Scores |
10; 2; 6; 2; 5; 2 | — |
| SECONDARY Change in Global Sleep Scores on the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Week 3. |
0.33; 0.77 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01325532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.