Adjunctive Treatment of Major Depression Utilizing Auricular Acupuncture

Major Depressive Disorder Clinical Trial

Official title:

Adjunctive Treatment of Major Depression Utilizing Auricular Acupuncture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02579343
• Other study ID #: FloridaGCU
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: May 2016

Study information

• Verified date: September 2021
• Source: Florida Gulf Coast University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Auricular Acupuncture
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.

Drug:
• Sham Auricular Acupuncture + Lexapro
Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current).

Locations

Country	Name	City	State
United States	Counseling and Psychological Services	Fort Myers	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Gulf Coast University

Country where clinical trial is conducted

United States, 

References & Publications (7)

Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med. 2004 Dec 21;141(12):901-10. — View Citation

Gori L, Firenzuoli F. Ear acupuncture in European traditional medicine. Evid Based Complement Alternat Med. 2007 Sep;4(Suppl 1):13-6. doi: 10.1093/ecam/nem106. — View Citation

MacPherson H, Richmond S, Bland M, Brealey S, Gabe R, Hopton A, Keding A, Lansdown H, Perren S, Sculpher M, Spackman E, Torgerson D, Watt I. Acupuncture and counselling for depression in primary care: a randomised controlled trial. PLoS Med. 2013;10(9):e1001518. doi: 10.1371/journal.pmed.1001518. Epub 2013 Sep 24. — View Citation

Nixon MK, Cheng M, Cloutier P. An open trial of auricular acupuncture for the treatment of repetitive self-injury in depressed adolescents. Can Child Adolesc Psychiatr Rev. 2003 Feb;12(1):10-2. — View Citation

Qu SS, Huang Y, Zhang ZJ, Chen JQ, Lin RY, Wang CQ, Li GL, Wong HK, Zhao CH, Pan JY, Guo SC, Zhang YC. A 6-week randomized controlled trial with 4-week follow-up of acupuncture combined with paroxetine in patients with major depressive disorder. J Psychiatr Res. 2013 Jun;47(6):726-32. doi: 10.1016/j.jpsychires.2013.02.004. Epub 2013 Mar 14. — View Citation

Sinyor M, Schaffer A, Levitt A. The sequenced treatment alternatives to relieve depression (STAR*D) trial: a review. Can J Psychiatry. 2010 Mar;55(3):126-35. Review. — View Citation

Wang SM, Peloquin C, Kain ZN. The use of auricular acupuncture to reduce preoperative anxiety. Anesth Analg. 2001 Nov;93(5):1178-80, table of contents. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks	Instrument developed to assess functional impairment in three inter-related domains; work/school, social and family life. Items are scored on a 0 - 10 point scale. Higher scores indicate more functional impairment.	Assessed at baseline and 6 weeks.
Primary	Change of Mean Score of the Behavioral Health Measure-20 Between Baseline and End of Study	The Behavioral Health Measure - 20 (BHM-20) is a 20-item client-report questionnaire that assesses the three phases of behavioral health: (a) well-being (distress, life satisfaction, motivation), (b) psychological symptoms (depression, anxiety, panic disorder, mood swings associated with bipolar disorder, eating disorder, alcohol/drug abuse, suicidality, risk of violence), and (c) life functioning (work/school, intimate relationships, social relationships, life enjoyment). The BHM-20 assesses the most frequently seen problems in outpatient psychotherapy. Scores range from 0-4. Lower scores indicate more distress.	Assessed at Baseline and After Treatment, Approximately 6 Weeks later.