Depression Clinical Trial
Official title:
Electroacupuncture for Major Depression: A Pilot Study
This study will compare the safety, efficacy, and tolerability of electroacupuncture (EA) and sham electroacupuncture (SA) for the treatment of major depression.
Status | Completed |
Enrollment | 57 |
Est. completion date | May 2007 |
Est. primary completion date | May 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UPMC Shadyside, Center for Complementary Medicine | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
National Center for Complementary and Integrative Health (NCCIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Antidepressant Response, Defined as a Hamilton Depression Rating Scale Score Relative Decrease of 50 % or More and a Final Score < 10 | Change from Baseline to Post-Intervention Endpoint | No | |
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) | Mean Change from Baseline to Post-Intervention Endpoint | No | |
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) | Mean Change from Baseline to Post-Intervention Endpoint | No | |
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) | Mean Change from Baseline to Post-Intervention Endpoint | No |
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