CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 57 enrolled
Drug / intervention
Electroacupuncture +1 moreprocedure
Likely dose
Electroacupuncture: needles at GV-20 and yin tang with electrical stimulation (30 mm x 0.22 mm sterile stainless steel needles, ~1 mm depth)AI-extracted
Key inclusion· 4
  • ✓Meet SCID criteria for Major Depressive Disorder (Single or Recurrent) with current mild or moderate episode
  • ✓Significant depressive symptoms (HRSD >14)
  • ✓Able to communicate in English
  • ✓Able to provide informed consent
Key exclusion· 7
  • ✕Prior acupuncture treatment for any condition
  • ✕History of seizure disorder or significant seizure risk factors (brain trauma, recent stroke, brain tumor)
  • ✕Currently requires antidepressant or other psychotropic medications
  • ✕Chronic major depression (duration ≥2 years)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00071110
NCT00071110Phase 2Completed
CompareCT.gov

Electroacupuncture for Major Depression: A Pilot Study

National Center for Complementary and Integrative Health (NCCIH)·interventional·Posted Oct 15, 2003·Updated Jan 11, 2010

In Brief

A Phase 2 clinical trial evaluating Electroacupuncture and Sham for Depression and Depressive Disorder. Completed, enrolled 57 participants across 1 site.

Detailed Summary

This study will compare the safety, efficacy, and tolerability of electroacupuncture (EA) and sham electroacupuncture (SA) for the treatment of major depression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Depressive Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 15, 2003
Enrollment StartMar 1, 2004
Primary CompletionMay 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 22.7 years ago

Interventions

Electroacupunctureprocedure

For subjects randomized to EA, needles were placed at points GV-20-on the crown of the head and yin tang-on the midline of the forehead roughly at the glabella and treated with electrical stimulation. 30 mm x 0.22 mm sterile stainless steel needles were placed obliquely to a depth of approximately 10 mm and were connected to face-microelectrodes which were connected to the Pantheon Research PENS-Electrostimulator. Electricity was provided at a frequency of 2 Hz and set to a voltage which resulted in the perception of a mild intensity stimulation.

Shamprocedure

For subjects randomized to SA, two needles were placed laterally on the scalp, 3 cuns superior to the temporal attachment of the helix of the ear. This point was selected as it does not correspond to any specific meridian acupuncture point. A disabled electrical cable was connected to the needles and the electrostimulator, with light blinking at 2 Hz but no electrical stimulation provided.