Trial Outcomes & Findings for Adjunctive Treatment of Major Depression Utilizing Auricular Acupuncture (NCT NCT02579343)
NCT ID: NCT02579343
Last Updated: 2021-10-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
Assessed at baseline and 6 weeks.
Results posted on
2021-10-12
Participant Flow
Recruitment period began during the summer of 2015 and continued through the spring of 2016. All participants were recruited through Counseling and Psychological Services.
Two potential participants immediately dropped from study prior to group assignment related to scheduling and commitment concerns.
Participant milestones
| Measure |
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 in this group will be treated twice weekly during their follow-up visits with micro-currents of electricity through auricular acupuncture.
Auricular Acupuncture: Auricular acupuncture is a form of acupuncture which utilizes the surface ear to identify points of inflammation in the body. It does this 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. 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 + 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).
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).
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adjunctive Treatment of Major Depression Utilizing Auricular Acupuncture
Baseline characteristics by cohort
| Measure |
Auricular Acupuncture + Lexipro
n=7 Participants
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.
Auricular Acupuncture: Auricular acupuncture is a form of acupuncture which utilizes the surface ear to identify points of inflammation in the body. It does this 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. 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 + Lexapro
n=6 Participants
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).
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).
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Auricular Acupuncture + Lexipro
n=7 Participants
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.
Auricular Acupuncture: Auricular acupuncture is a form of acupuncture which utilizes the surface ear to identify points of inflammation in the body. It does this 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. 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 + Lexapro
n=6 Participants
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).
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).
|
|---|---|---|
|
Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks
Work / School Domain
|
-3.57 units on a scale
Standard Deviation 1.03
|
-1.5 units on a scale
Standard Deviation 1.19
|
|
Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks
Social Life Domain
|
-2.29 units on a scale
Standard Deviation 1.16
|
-1.0 units on a scale
Standard Deviation 1.20
|
|
Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks
Family Life Domain
|
-3.42 units on a scale
Standard Deviation 1.14
|
-0.17 units on a scale
Standard Deviation 0.70
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Auricular Acupuncture + Lexipro
n=7 Participants
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.
Auricular Acupuncture: Auricular acupuncture is a form of acupuncture which utilizes the surface ear to identify points of inflammation in the body. It does this 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. 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 + Lexapro
n=6 Participants
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).
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).
|
|---|---|---|
|
Change of Mean Score of the Behavioral Health Measure-20 Between Baseline and End of Study
|
0.89 units on a scale
Standard Deviation 0.280
|
0.47 units on a scale
Standard Deviation 0.348
|
Adverse Events
Auricular Acupuncture + Lexipro
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Auricular Acupuncture + Lexapro
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place