Effectiveness of Acupuncture for Depressed Patients Not Taking Antidepressant Medications

Mass General Brigham

Status

Completed

Conditions

Depression

Treatments

Procedure: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT01634022

2004P002819

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.