Adjunctive Treatment of Major Depression Utilizing Auricular Acupuncture

NCT02579343 | Completed Results

• 1 other identifier: FloridaGCU
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (2)

Auricular Acupuncture + Lexapro

EXPERIMENTAL

Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants in this group will be treated twice weekly during their follow-up visits with micro-currents of electricity through auricular acupuncture.

Device: Auricular Acupuncture

Sham Auricular Acupuncture + Lexapro

SHAM COMPARATOR

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).

Drug: Sham Auricular Acupuncture + Lexapro

Interventions

Auricular Acupuncture DEVICE

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.

Also known as: Pointer Excel II

Auricular Acupuncture + Lexapro

Sham Auricular Acupuncture + Lexapro DRUG

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).

Also known as: SSRI Lexapro

Sham Auricular Acupuncture + Lexapro

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida Gulf Coast University: lead

Study Sites (1)

Counseling and Psychological Services

Fort Myers, Florida, 33965, United States

Location

Related 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. doi: 10.7326/0003-4819-141-12-200412210-00006.

  PMID: 15611487 BACKGROUND

• 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.

  PMID: 18227925 BACKGROUND

• 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.

  PMID: 24086114 BACKGROUND

• 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.

  PMID: 19030475 BACKGROUND

• 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.

  PMID: 23498306 BACKGROUND

• 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. doi: 10.1177/070674371005500303.

  PMID: 20370962 BACKGROUND

• 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. doi: 10.1097/00000539-200111000-00024.

  PMID: 11682391 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Acupuncture, Ear; Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Main limitation related to small sample size due to difficulties with recruitment. Please interpret results with care.

Results Point of Contact

• Title: Adam McCabe
• Organization: Counseling and Psychological Services

amccabe@fgcu.edu

239-590-7950

Study Officials

• John Prater, DO

  Counseling and Psychological Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Compliance Coordinator

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 19, 2015
• Study Start: August 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 12, 2021
• Results First Posted: October 12, 2021

Record last verified: 2021-09

Locations

US (1)