Phase 2
Completed N=57
Electroacupuncture for Major Depression
Source: ClinicalTrials.gov NCT00071110 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcomePrimary: Antidepressant Response, Defined as a Hamilton Depression Rating Scale Score Relative Decrease of 50 % or More and a Final Score < 10 — 11; 11 participants
Summary
This study will compare the safety, efficacy, and tolerability of electroacupuncture (EA) and sham electroacupuncture (SA) for the treatment of major depression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antidepressant Response, Defined as a Hamilton Depression Rating Scale Score Relative Decrease of 50 % or More and a Final Score < 10 |
11; 11 | — |
| SECONDARY Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Physical Component Score (MOSPCS) |
0.54; -1.65 | 0.32 |
| SECONDARY Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS) |
6.23; 14.12 | 0.09 |
| SECONDARY Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI) |
-1.04; 6.81 | 0.17 |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00071110). 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.