Clinical trial NCT01634022: Effectiveness of Acupuncture for Depressed Patients Not Taking Antidepressant Medications
Official title: Effectiveness of Acupuncture on Treating Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Acupuncture
Antidepressant
Monotherapy
Depression
Alternative treatments
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-07-06
Enrollment: 64
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: Acupuncture is a popular complementary/alternative therapy that has been in use for thousands of years for the treatment of various medical and psychiatric conditions, including Major Depressive Disorder (MDD). In this study, the investigators applied the investigators acupuncture-treatment-for-depression protocol, based on Traditional Chinese Medicine (TCM) principles for treating MDD, to depressed patients not taking any antidepressant medications (a protocol that the investigators previously piloted as a medication augmentation therapy for partial responders with MDD).

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.


Eligibility criteria: Inclusion Criteria:

* Has current or past DSM-IV MDD diagnosis based on SCID; AND current 17-Hamilton Rating Scale for Depression (BRSD) score of 14 or above
* 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:

* Patients with 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 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.

Primary outcomes:
measure: Change in scores on the Hamilton Depression Rating Scale, 17 items (HAM-D-17)
timeFrame: Baseline and all acupuncture sessions (weekly) for 8 weeks
Secondary outcomes:
measure: Response to treatment, defined as a 50% or greater improvement in HAM-D-17 score compared to baseline
timeFrame: Baseline and all acupuncture sessions (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: 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.