N/A
Completed N=13
Adjunctive Treatment of Major Depression Utilizing Auricular Acupuncture
Source: ClinicalTrials.gov NCT02579343 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks — -3.57; -1.5; -2.29; -1.0 units on a scale — p=.05
Summary
This will be a randomized, single blind study of 6 weeks duration involving the use of auricular acupuncture or sham acupuncture in the adjunctive treatment of depression in college students.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks |
-3.57; -1.5; -2.29; -1.0; -3.42; -0.17 | .05 |
| PRIMARY Change of Mean Score of the Behavioral Health Measure-20 Between Baseline and End of Study |
0.89; 0.47 | .05 |
Eligibility Criteria
Inclusion Criteria
- Meets DSM-V criteria for major depression single episode or recurrent as a primary diagnosis. Participants must have been symptomatic with depression for 2 months or more and less than 18 months.
Exclusion Criteria
- a current diagnosis or history of alcohol or substance abuse or dependence that has not been in full and sustained remission for 3 months
- any current psychiatric diagnosis which is the primary focus of treatment other than major depression
- current history of mania or hypomania, schizophrenia, or any psychotic disorder, obsessive-compulsive disorder, autism spectrum conditions, organic mental disorders or mental disorders due to a physical condition
- the participant has a history of lack of response to a previous adequate treatment with 2 antidepressants for major depression at a standard dose for at least a six-week period of time
- any axis II disorder
- if the participant is female the participant agrees to use adequate contraception from the signing of the informed consent and throughout the study and for 30 days afterwards. pregnant or lactating females or those intending to become pregnant during the study are excluded
- if the participant is unlikely to comply with a clinical study protocol or is unsuitable for the study as determined by the principal investigator
- if the participant has clinically significant unstable physical illness such as neurologic disorders, diabetes, immunologic disorders, or any disturbance of a metabolic nature which may compromise the study
- the participant has a risk of suicide according to the investigators clinical judgment and according to the screening instruments used in the trial
- the subject has started receiving formal cognitive psychotherapy within 30 days from screening or plans to initiate such therapy during the study.
Data sourced from ClinicalTrials.gov (NCT02579343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.