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Adjunctive Treatment of Major Depression Utilizing Auricular Acupuncture

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ClinicalTrials.gov Identifier: NCT02579343
Recruitment Status : Unknown
Verified October 2015 by Dr. John Prater, Florida Gulf Coast University.
Recruitment status was:  Recruiting
First Posted : October 19, 2015
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. John Prater, Florida Gulf Coast University

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Auricular Acupuncture Drug: Sham Auricular Acupuncture + Lexapro Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Adjunctive Treatment of Major Depression Utilizing Auricular Acupuncture
Study Start Date : August 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Auricular Acupuncture + Lexipro
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
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.
Other Name: Pointer Excel II

Sham Comparator: 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).
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).
Other Name: SSRI Lexipro




Primary Outcome Measures :
  1. Change from baseline score of the Behavioral Health Measure-20 through 6 weeks [ Time Frame: Once Weekly for 6 weeks (duration 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.


Secondary Outcome Measures :
  1. Change from baseline score of the Sheehan Disability Scale through 6 weeks [ Time Frame: Once Weekly for 6 weeks (duration of study) ]
    Instrument developed to assess functional impairment in three inter-related domains; work/school, social and family life.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579343


Contacts
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Contact: John Prater, DO 239-590-7950 jprater@fgcu.edu
Contact: Adam McCabe, Ph.D. 239-590-7950 amccabe@fgcu.edu

Locations
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United States, Florida
Counseling and Psychological Services Recruiting
Fort Myers, Florida, United States, 33965
Contact: John Prater, DO    239-590-7950    jprater@fgcu.edu   
Contact: Adam McCabe, Ph.D.    239-590-7950    amccabe@fgcu.edu   
Sponsors and Collaborators
Florida Gulf Coast University
Investigators
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Principal Investigator: John Prater, DO Counseling and Psychological Services

Publications of Results:

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Responsible Party: Dr. John Prater, Staff Psychiatrist, Florida Gulf Coast University
ClinicalTrials.gov Identifier: NCT02579343     History of Changes
Other Study ID Numbers: FloridaGCU
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: October 19, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents