Effectiveness of Acupuncture for Depressed Patients Not Taking Antidepressant Medications
NCT ID: NCT01634022
Last Updated: 2012-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
64 participants
INTERVENTIONAL
2005-05-31
2011-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The investigators specifically investigated the efficacy, safety, and tolerability of this TCM-based protocol for such patients, as well as potential differences in outcomes between weekly vs. twice-weekly treatment. The investigators hypothesized that acupuncture monotherapy would be associated with a response rate of at least 50%, which the investigators defined as a decrease in depressive symptoms from the beginning to the end of the study of 50% or more, and that the response would be greater among patients who received acupuncture 2 times per week (vs. 1 time per week). The investigators also hypothesized that acupuncture would be associated with minimal side effects.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Acupuncture
Adults with depression who are not currently taking an antidepressant medication.
Acupuncture
5 specific body acupoints (HT-7 and LI-4 on the hands bilaterally, and ST-36, SP-6, and LR-3 on the legs bilaterally) with gentle manual tonification every 10 min. Two acupoints along the midline of the head, GV-20 and GV-24.5 (Yintang), were also used with a 2 Hz current applied from GV-20 (-) to GV24.5 (+).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Acupuncture
5 specific body acupoints (HT-7 and LI-4 on the hands bilaterally, and ST-36, SP-6, and LR-3 on the legs bilaterally) with gentle manual tonification every 10 min. Two acupoints along the midline of the head, GV-20 and GV-24.5 (Yintang), were also used with a 2 Hz current applied from GV-20 (-) to GV24.5 (+).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age between 18-65
* No treatment with antidepressant(s) in the past 3 months
* If patient has received psychotherapy, no initiation or termination of therapy in the past 3 months.
Exclusion Criteria
* Conditions that could make it difficult to conclusively determine that depressive symptoms were the result of MDD and not some other condition, including substance abuse or dependence within the last 6 months, medical conditions that could produce depression, including epilepsy, history of an abnormal EEG, severe head trauma, or stroke.
* Serious uncontrolled medical conditions \[e.g. poorly controlled diabetes, severe congestive heart failure\], or other medical conditions that have not been stable for at least 3 months.
* Electroconvulsive therapy (ECT) during the last year.
* Current active suicidal or self-injurious potential necessitating immediate treatment.
* Currently receiving concomitant Acupuncture Treatment, or any Acupuncture treatment in the past three months.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Massachusetts General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Albert Yeung
Director of Primary Care Research, Depression Clinical and Research Program
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Albert Yeung, MD, ScD
Role: PRINCIPAL_INVESTIGATOR
Depression Clinical and Research Program, Massachusetts General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Depression Clinical and Research Program, Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Mischoulon D, Brill CD, Ameral VE, Fava M, Yeung AS. A pilot study of acupuncture monotherapy in patients with major depressive disorder. J Affect Disord. 2012 Dec 10;141(2-3):469-73. doi: 10.1016/j.jad.2012.03.023. Epub 2012 Apr 21.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2004P002819
Identifier Type: -
Identifier Source: org_study_id