Major Depressive Disorder
Conditions
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.
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.
Interventions
DEVICEAuricular 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.
DRUGSham 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).
Sponsors
Florida Gulf Coast University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment period began during the summer of 2015 and continued through the spring of 2016. All participants were recruited through Counseling and Psychological Services.
Pre-assignment details
Two potential participants immediately dropped from study prior to group assignment related to scheduling and commitment concerns.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 7 |
| 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). | 6 |
| Total | 13 |
Baseline characteristics
| Characteristic | Auricular Acupuncture + Lexipro | Sham Auricular Acupuncture + Lexapro | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 6 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 4 Participants | 9 Participants |
| Region of Enrollment United States | 7 participants | 6 participants | 13 participants |
| Sex: Female, Male Female | 7 Participants | 1 Participants | 8 Participants |
| Sex: Female, Male Male | 0 Participants | 5 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 6 |
| other Total, other adverse events | 0 / 7 | 0 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 |
Outcome results
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.
Time frame: Assessed at baseline and 6 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Auricular Acupuncture + Lexipro | 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 |
| Auricular Acupuncture + Lexipro | 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 |
| Auricular Acupuncture + Lexipro | 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 |
| Sham Auricular Acupuncture + Lexapro | Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks | Work / School Domain | -1.5 units on a scale | Standard Deviation 1.19 |
| Sham Auricular Acupuncture + Lexapro | Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks | Social Life Domain | -1.0 units on a scale | Standard Deviation 1.2 |
| Sham Auricular Acupuncture + Lexapro | Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks | Family Life Domain | -0.17 units on a scale | Standard Deviation 0.7 |
p-value: 0.05Repeated Measures Analysis of Variance
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.
Time frame: Assessed at Baseline and After Treatment, Approximately 6 Weeks later.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Acupuncture + Lexipro | Change of Mean Score of the Behavioral Health Measure-20 Between Baseline and End of Study | 0.89 units on a scale | Standard Deviation 0.28 |
| Sham Auricular Acupuncture + Lexapro | Change of Mean Score of the Behavioral Health Measure-20 Between Baseline and End of Study | 0.47 units on a scale | Standard Deviation 0.348 |
p-value: 0.05Repeated Measures Analysis of Variance