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Electroacupuncture for Major Depression Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Electroacupuncture for Major Depression conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Electroacupuncture for Major Depression Clinical research trials and Electroacupuncture for Major Depression health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Electroacupuncture for Major Depression. Electroacupuncture for Major Depression Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Electroacupuncture for Major Depression clinical trial. Participants oftentimes recieve the most expert healthcare available for their Electroacupuncture for Major Depression condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Electroacupuncture for Major Depression  Electroacupuncture for Major Depression
Electroacupuncture for Major Depression
For Condition: Depressive Disorder,Depression
Status: Not yet recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: This study will compare the safety, efficacy, and tolerability of electroacupuncture (EA) and sham electroacupuncture (SA) for the treatment of major depression.
Details: Major depression is a common and serious mental illness. It is associated with a markedly lower quality of life, significant functional impairment, and premature death due to suicide or comorbid physical illness. Over the past 50 years, effective and safe treatments for major depression have been developed, including antidepressant pharmacotherapy, psychotherapy, and electroconvulsive therapy. However, many Americans who suffer from a depressive disorder either do not elect to receive one of these conventional treatments or do not complete an adequate course of treatment. A growing number of Americans with depression are choosing to be treated with complementary and alternative therapies. Acupuncture, in particular, is increasingly being used to treat depression even though only limited data support its safety and efficacy. This pilot study will use a randomized parallel-group design to compare the safety, efficacy, and tolerability of electroacupuncture (EA) and sham electroacupuncture (SA) for the treatment of major depression. Over a 15-month period, 60 adult outpatients with a major depressive disorder of mild or moderate severity (as defined by the DSM-IV) will be randomized to either 12 sessions of EA or SA to be provided over 6 weeks. Safety and symptomatic improvement (as measured with the Hamilton Rating Scale for Depression [HRSD]) will constitute the primary outcome measures. Tolerability and functional improvement will constitute secondary outcome measures.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
BenoitMulsant, Principal Investigator, University of Pittsburgh
UPMC Shadyside, Center for Complementary Medicine
Pittsburgh, Pennsylvania, 15213
United States
Jennifer Karabin 412-623-6872
Additional Information:
Study ID Numbers: R21 AT001218-01A1;
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071110
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Electroacupuncture for Major Depression
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