Clinical trial NCT02579343: Adjunctive Treatment of Major Depression Utilizing Auricular Acupuncture
Official title: Adjunctive Treatment of Major Depression Utilizing Auricular Acupuncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Florida Gulf Coast University
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This will be a randomized, single blind study of 6 weeks duration involving the use of auricular acupuncture or sham acupuncture in the add adjunctive treatment of depression in college students. College students presenting for care at Counseling and Psychological Services, who meet Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V) criteria for major depression single episode or recurrent will be included in the trial. Subjects will be randomized into a sham auricular acupuncture group, or a treatment acupuncture group. All subjects who meet the inclusion criteria will be treated with the Selective serotonin reuptake inhibitor (SSRI) Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Some subjects will be treated twice weekly during their follow-up visits with sham auricular acupuncture, some subjects will be treated with micro-currents of electricity in the auricular acupuncture group. The duration of the trial will be 6 weeks.

Auricular acupuncture is a form of acupuncture which utilizes the surface of the external ear to identify points of inflammation in the body. It does this, in this case, by utilizing the Pointer Excel II probe which can pick up a change in electrical conductivity on the surface of the ear, which reflects an internal point of inflammation or stress. Once the point of inflammation is identified, the Pointer Excel II is equipped with a sensor that it will not only illuminate by way of a small light on the front of the probe will also identify the point of inflammation by way of an auditory signal. Once the point of inflammation is identified auricular acupuncture will treat that point with a micro-current of electricity for several seconds. In the case of treatment, there will be an auditory alarm followed by a micro -current dose of electricity. Sham acupuncture will be characterized by the auditory alarm, but no current will be applied to the participants ear.

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.

Primary outcomes:
measure: Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks
timeFrame: Assessed at baseline and 6 weeks.
measure: Change of Mean Score of the Behavioral Health Measure-20 Between Baseline and End of Study
timeFrame: Assessed at Baseline and After Treatment, Approximately 6 Weeks later.
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Counseling and Psychological Services
state: Florida
Study officials:
affiliation: Counseling and Psychological Services
name: John Prater, DO
role: PRINCIPAL_INVESTIGATOR
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