Clinical trial NCT01633996: Effectiveness of Acupuncture for Depressed Patients Taking Antidepressant Medications
Official title: Effectiveness of Acupuncture Augmentation on Treatment Resistant Depressed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Acupuncture
Antidepressant
Augmentation
Depression
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-07-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this research study, the investigators piloted a uniform acupuncture treatment protocol among adults with depression who were taking an antidepressant medication that was providing only partial or no symptom alleviation. The study's aims were evaluate the efficacy, safety, and tolerability of acupuncture augmentation treatment among this population. The investigators hypothesized that acupuncture as an augmentation treatment 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.


Eligibility criteria: Inclusion Criteria:

* Ages 18-65
* A HAM-D-17 score of \>= 14
* Partial or nonresponse to a standard antidepressant (monotherapy or combination) at an adequate dose over the past 8 or more weeks (natural agents such as omega-3 fatty acids, St John's wort, SAMe, and folic acid, were allowed as antidepressants)
* Concurrent psychotherapy was allowed, provided that it was not initiated within the 3 months prior to study entry.

Exclusion Criteria:

* A primary diagnosis other than major depressive disorder, or any history of psychosis or mania
* Conditions that could make it difficult to conclusively determine that depressive symptoms were the result of major depression and not some other condition, including any form of substance abuse or dependence within the last 6 months, other medical conditions that could be the basis of a 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 had not been stable for at least 3 months
* Having had electroconvulsive therapy (ECT) during the past year
* Current active suicidal or self-injurious potential necessitating immediate treatment.

Primary outcomes:
measure: Response to acupuncture augmentation treatment, defined as a change in scores on the Hamilton Depression Rating Scale, 17 items (HAM-D-17) from baseline to endpoint.
timeFrame: Baseline and all acupuncture sessions (weekly) for 8 weeks
Secondary outcomes:
measure: Evidence of acupuncture augmentation's tolerability and acceptability, as determined clinically by the participant and study doctor.
timeFrame: Once per acupuncture session (weekly) for 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Depression Clinical and Research Program, Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Depression Clinical and Research Program, Massachusetts General Hospital
name: Albert Yeung, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yeung AS, Ameral VE, Chuzi SE, Fava M, Mischoulon D. A pilot study of acupuncture augmentation therapy in antidepressant partial and non-responders with major depressive disorder. J Affect Disord. 2011 Apr;130(1-2):285-9. doi: 10.1016/j.jad.2010.07.025. Epub 2010 Aug 6.