Electroacupuncture for Major Depression

NCT00071110 | Completed Phase 2 Results

• 1 other identifier: R21AT001218-01A1
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression; Depressive Disorder

Keywords

Acupuncture; Electroacupuncture; Alternative therapy

Outcome Measures

Primary Outcomes (1)

• Antidepressant Response, Defined as a Hamilton Depression Rating Scale Score Relative Decrease of 50 % or More and a Final Score < 10

  Number of participants whose Hamilton Depression Rating Scale score decreased at least 50% and had a final score less than 10. Minimum score = 0 (best). Maximum score = 52 (worst). The 17 item scale assesses depression symptoms, including Depressed Mood, Feelings of Guilt, Suicidal Ideation, Insomnia, Anxiety, Weight Change, and Insight.

  Change from Baseline to Post-Intervention Endpoint

Secondary Outcomes (3)

• Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Physical Component Score (MOSPCS)

  Mean Change from Baseline to Post-Intervention Endpoint

• Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS)

  Mean Change from Baseline to Post-Intervention Endpoint

• Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI)

  Mean Change from Baseline to Post-Intervention Endpoint

Study Arms (2)

1

EXPERIMENTAL

Electroacupuncture (EA).

Procedure: Electroacupuncture

2

PLACEBO COMPARATOR

Sham

Procedure: Sham

Interventions

Electroacupuncture PROCEDURE

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.

1

Sham PROCEDURE

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.

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet SCID criteria for a Major Depressive Disorder (Single or Recurrent) with a current major depressive episode of mild or moderate severity
• Significant symptoms of depression (HRSD \> 14)
• Ability to communicate in English
• Give informed consent in accordance with local IRB regulations

You may not qualify if:

• Personal physician's recommendation against enrollment because the patient is physically unstable or for other reasons
• Having been treated with acupuncture for any condition
• History of seizure disorder or significant risk factors for a seizure disorder (e.g., history of brain trauma, recent stroke, or brain tumor)
• Need to remain on antidepressant or other psychotropic medications
• Absence of depressive symptoms severe enough (i.e., HRSD \< 14) at the baseline assessments
• Significant cognitive impairment, as assessed by a total score on the MMSE \< 25. A recommendation for referral to a neurologist or a psychiatrist will be made to the patient in these cases.
• Chronic major depression (i.e, duration of 2 years or longer) A recommendation for referral to a psychiatrist will be made in these cases.
• Major depressive episode severe or severe with psychotic features (as per DSM-IV/SCID) or with acutely suicidality. A recommendation for psychiatric referral will be made in these cases. Bipolar disorder, psychotic features, or a psychotic disorder (specifically: schizophrenia, delusional disorder, or schizoaffective disorder). A recommendation for psychiatric referral will be made in these cases.
• Met criteria for a diagnosis of alcohol substance abuse or dependence within the past six months. A recommendation for referral to a mental health professional will be made in these cases.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

UPMC Shadyside, Center for Complementary Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Andreescu C, Glick RM, Emeremni CA, Houck PR, Mulsant BH. Acupuncture for the treatment of major depressive disorder: a randomized controlled trial. J Clin Psychiatry. 2011 Aug;72(8):1129-35. doi: 10.4088/JCP.10m06105. Epub 2011 May 3.

  PMID: 21672495 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder

Interventions

Electroacupuncture; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Limitations and Caveats

Four participants were excluded from the analyses because of a protocol violation. In the Sham Acupuncture group, the acupuncturist placed unelectrified needles in GV-20 and Yin tang points instead of placing them laterally.

Results Point of Contact

• Title: Benoit H. Mulsant, MD
• Organization: University of Pittsburgh

benoit_mulsant@camh.net

(416) 535-8501

Study Officials

• Benoit H Mulsant, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 10, 2003
• First Posted: October 15, 2003
• Study Start: March 1, 2004
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: January 11, 2010
• Results First Posted: January 11, 2010

Record last verified: 2009-12

Locations

US (1)