Major Depressive DisorderNCT02579343
Adjunctive Treatment of Major Depression Utilizing Auricular Acupuncture
A study testing Auricular Acupuncture in people with Major Depressive Disorder, run by Florida Gulf Coast University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Auricular Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Counseling and Psychological Services
Fort Myers, Florida, 33965
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Auricular Acupuncture, Sham Auricular Acupuncture + Lexapro
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular AcupunctureDevice
Also called Pointer Excel II
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.
Sham Auricular Acupuncture + LexaproDrug
Also called SSRI 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Sham Auricular Acupuncture + Lexapro |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Assessed at Baseline and After Treatment, Approximately 6 Weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Gulf Coast University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherry Alexander, Florida Gulf Coast University
- Investigators
- John Prater, DO, Principal investigator, Counseling and Psychological Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579343
- Sponsor's protocol ID
- FloridaGCU
- Status last verified
- Sep 2021
- First submitted
- 5 Oct 2015
- Last updated
- 12 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 15611487Gori 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.
PubMed 18227925MacPherson 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.
PubMed 24086114Nixon 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.
PubMed 19030475Qu 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.
PubMed 23498306Sinyor 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.
PubMed 20370962Wang 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.
PubMed 11682391
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Treatment of Major Depression Utilizing Auricular Acupuncture
- ClinicalTrials.gov ID
- NCT02579343
- Acronym / sponsor ID
- FloridaGCU
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Florida Gulf Coast UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Posted 12 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupuncture + Lexapro | Experimental | Device: Auricular AcupunctureParticipants 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. |
| Sham Auricular Acupuncture + Lexapro | Sham comparator | Drug: Sham Auricular Acupuncture + LexaproParticipants 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). |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular AcupunctureAlso: Pointer Excel IIAuricular 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. | Device | Auricular Acupuncture + Lexapro |
| Sham Auricular Acupuncture + LexaproAlso: SSRI LexaproParticipants 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 |
Primary outcome
Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks
Time frame: Assessed at baseline and 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.
Change of Mean Score of the Behavioral Health Measure-20 Between Baseline and End of Study
Time frame: Assessed at Baseline and After Treatment, Approximately 6 Weeks later.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15611487Berman 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.
- Background: PubMed 18227925Gori 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.
- Background: PubMed 24086114MacPherson 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.
- Background: PubMed 19030475Nixon 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.
- Background: PubMed 23498306Qu 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.
- Background: PubMed 20370962Sinyor 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.
- Background: PubMed 11682391Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Prater, DO principal investigator
Counseling and Psychological Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Acupuncture in people with Major Depressive Disorder, run by Florida Gulf Coast University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks (time frame: Assessed at baseline and 6 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02579343, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.