Major Depressive Disorder, MDD
Conditions
Keywords
tACS, Major Depressive Disorder, MDD, mood symptoms, sham
Brief summary
Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) on patients with Major Depressive Disorder (MDD).
Detailed description
Central Hypothesis: Non-invasive brain stimulation that suppresses alpha oscillation reduces cortical hyperactivity and causes a clinical improvement Aim 1: To conduct a pilot clinical trial to establish feasibility and to collect first effectiveness data for the use of tACS to renormalize pathological alpha oscillations in the dorsolateral prefrontal cortex (dl-pfc) of unmedicated patients with MDD by comparing MADRS scores from baseline and one month follow up. Aim 2: Compare alpha oscillation power from resting state EEG recordings on the first and last day of stimulation. Collect EEG data at the one month follow up visit using this data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers.
Interventions
DEVICEtACS (alpha)
DEVICEtACS (gamma)
Sponsors
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, 18-65 years old * Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV) diagnosis of MDD; unipolar, non-psychotic * Hamilton Depression Rating Scale score \>8 * Capacity to understand all relevant risks and potential benefits of the study (informed consent) * Meet criteria for low suicide risk * Willing to comply with all study procedures and be available to do so for the duration of the study * Women of reproductive potential must use highly effective contraception
Exclusion criteria
* DSM-IV diagnosis of alcohol of substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months * Current use of benzodiazepines or anti-epileptic drugs * Current axis I mood, or psychotic disorder other than major depressive disorder * Lifetime comorbid psychiatric bipolar or psychotic disorder * Eating disorder (current or within the past 6 months) * Obsessive-compulsive disorder (lifetime) * Post traumatic stress disorder (PTSD; current or within the last 6 months) * Attention Deficit Hyperactivity Disorder (ADHD; currently under treatment) * Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study * Neurological disorders, including but not limited to history of seizures (except childhood febrile seizures and ECT induced seizures), dementia, history of stroke, Parkinson's disease, multiple sclerosis, cerebral aneurism * Medical or neurological illness (unstable cardiac disease, AIDS, malignancy, liver or renal impairment) or treatment for a medical disorder that could interfere with study participation * History of traumatic brain injury, reoccurring seizures or later cognitive rehabilitation, or causing cognitive sequelae * Prior brain surgery * Any brain devices/implants, including cochlear implants and aneurysm clips * Co-morbid neurological condition (i.e. seizure disorder, brain tumor) * Non English speakers * Pregnancy, nursing, or if female and fertile, unwilling to use appropriate birth control measures during study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | Baseline to F2 (4 weeks after completion of the intervention) | The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). A comparison of MADRS scores between baseline and F2 is the primary outcome measure (measured as change from baseline). In these results, negative values will indicate a decrease in depressive symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation | Baseline to Day 5 of Stimulation | The investigators will compare alpha oscillation power from resting state EEG recordings on the first day of stimulation (baseline) and last day of stimulation. The investigators will also collect EEG recordings data at a visit four weeks after completion of the intervention (F2). The investigators will use each of the three EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers. As the stimulation paradigm stimulates the frontal brain regions, the investigators will analyze alpha power change in all brain regions as well as frontal regions. |
| Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention | Baseline to F2 | The investigators will compare alpha oscillation power from resting state EEG recordings on the first day of stimulation (baseline) and at the follow-up visit four weeks after completion of the intervention. The investigators will also collect EEG on the fifth day of stimulation. The investigators will use each of the three EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers. As the stimulation paradigm stimulates the frontal brain regions, the investigators will analyze alpha power change in all brain regions as well as frontal regions. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Depression Rating Scale (HDRS) Score | Baseline to Day 5 of Stimulation; Baseline to F2 | The HDRS is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome. This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). The investigators will compare the scores between baseline and F2, with negative values indicating a decrease in depressive symptoms. |
| Clinical Global Impressions (CGI) Raw Score | Day 5; F2 (4 weeks after completion of treatment) | This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). The investigators will compare the scores between baseline and F2.The reported values are from Item 1 Severity of Illness on a likert scale of 1 to 7, with 1=Normal, not at all ill and 7 = Among the most extremely ill patients. |
| Change in Montreal Cognitive Assessment (MoCA) Score | Baseline to F2 | This measurement will be taken at baseline (first day of stimulation) and four weeks after completion of the intervention (F2). Total score ranges from 0 to 30, with higher values indicating better cognition. The investigators will compare the scores between baseline and F2. Reported values are the raw change (increase or decrease) from baseline. |
| Change in Beck Depression Inventory (BDI) Score | Baseline to Day 5; Baseline to F2 | This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). Higher scores indicate more depressive symptoms. Total score is out of 63 possible. The investigators will compare the scores between baseline and F2. In these results, negative values indicate a decrease in depressive symptoms. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited through advertisements (e.g., online, flyers) and self-identified with depression. Interested participants contacted the study team.
Pre-assignment details
Participants were randomly assigned to 1 of 3 arms: tACS (alpha), tACS (gamma), or sham stimulation. All conditions were delivered during awake, resting state for 40 minutes on 5 consecutive days. 98 participants signed consent, 40 did not meet criteria, 6 declined participation, and 20 were excluded for other reasons. 32 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| tACS (Alpha) 10 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes | 10 |
| tACS (Gamma) 40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes | 11 |
| Sham Stimulation Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation. | 11 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 1 |
| Overall Study | Protocol Deviation | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | tACS (Gamma) | Sham Stimulation | tACS (Alpha) | Total |
|---|---|---|---|---|
| Age, Continuous | 35.36 years STANDARD_DEVIATION 11.56 | 38.36 years STANDARD_DEVIATION 13.54 | 36.30 years STANDARD_DEVIATION 15.22 | 36.69 years STANDARD_DEVIATION 13.08 |
| Beck Depression Inventory (BDI) | 28.27 units on a scale STANDARD_DEVIATION 8.81 | 26.18 units on a scale STANDARD_DEVIATION 9.74 | 26.60 units on a scale STANDARD_DEVIATION 5.58 | 27.03 units on a scale STANDARD_DEVIATION 8.1 |
| Clinical Global Impression (CGI) | 3.82 units on a scale STANDARD_DEVIATION 0.6 | 3.73 units on a scale STANDARD_DEVIATION 0.79 | 4.10 units on a scale STANDARD_DEVIATION 0.99 | 3.88 units on a scale STANDARD_DEVIATION 0.79 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 10 Participants | 6 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 4 Participants | 6 Participants |
| Hamilton Depression Rating Scale (HDRS) | 14.64 units on a scale STANDARD_DEVIATION 3.53 | 14.55 units on a scale STANDARD_DEVIATION 6.12 | 17.90 units on a scale STANDARD_DEVIATION 4.51 | 15.63 units on a scale STANDARD_DEVIATION 4.94 |
| Montgomery-Asberg Depression Rating Scale (MADRS) | 25.00 units on a scale STANDARD_DEVIATION 7.21 | 24.55 units on a scale STANDARD_DEVIATION 5.18 | 28.80 units on a scale STANDARD_DEVIATION 6.36 | 26.03 units on a scale STANDARD_DEVIATION 6.39 |
| Montreal Cognitive Assessment (MoCA) | 27.27 units on a scale STANDARD_DEVIATION 1.62 | 27.82 units on a scale STANDARD_DEVIATION 2.48 | 28.20 units on a scale STANDARD_DEVIATION 1.99 | 27.75 units on a scale STANDARD_DEVIATION 2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 11 Participants | 9 Participants | 30 Participants |
| Region of Enrollment United States | 11 Participants | 11 Participants | 10 Participants | 32 Participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 9 Participants | 27 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 10 | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 11 | 0 / 11 |
Outcome results
Primary
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). A comparison of MADRS scores between baseline and F2 is the primary outcome measure (measured as change from baseline). In these results, negative values will indicate a decrease in depressive symptoms.
Time frame: Baseline to F2 (4 weeks after completion of the intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tACS (Alpha) | Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | -13.60 units on a scale | Standard Deviation 7.75 |
| tACS (Gamma) | Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | -8.82 units on a scale | Standard Deviation 8.94 |
| Sham Stimulation | Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | -8.27 units on a scale | Standard Deviation 10.88 |
Comparison: Null hypothesis: There is no difference baseline and the 4 week follow up in MADRS score between treatment groups.~Alternative hypothesis: There is a difference between baseline and the 4 week follow up MADRS score between treatment groups.p-value: >0.1ANOVA
Comparison: Null hypothesis: There is no difference baseline and the 4 week follow up in MADRS score between treatment groups.~Alternative hypothesis: There is a difference between baseline and the 4 week follow up MADRS score between treatment groups.p-value: <0.001ANOVA
p-value: >0.1ANOVA
Secondary
Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation
The investigators will compare alpha oscillation power from resting state EEG recordings on the first day of stimulation (baseline) and last day of stimulation. The investigators will also collect EEG recordings data at a visit four weeks after completion of the intervention (F2). The investigators will use each of the three EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers. As the stimulation paradigm stimulates the frontal brain regions, the investigators will analyze alpha power change in all brain regions as well as frontal regions.
Time frame: Baseline to Day 5 of Stimulation
Population: Only participants that completed all sessions are used in this task (per protocol participants); N = 26
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| tACS (Alpha) | Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation | All Brain Regions | -1.75 decibel (dB) | Standard Deviation 1.75 |
| tACS (Alpha) | Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation | Frontal Brain Regions | -1.23 decibel (dB) | Standard Deviation 1.29 |
| tACS (Gamma) | Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation | All Brain Regions | 0.53 decibel (dB) | Standard Deviation 1.79 |
| tACS (Gamma) | Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation | Frontal Brain Regions | 0.12 decibel (dB) | Standard Deviation 1.68 |
| Sham Stimulation | Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation | All Brain Regions | 0.24 decibel (dB) | Standard Deviation 1.22 |
| Sham Stimulation | Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation | Frontal Brain Regions | -0.02 decibel (dB) | Standard Deviation 1.2 |
Comparison: Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.p-value: <0.05ANOVA
Comparison: Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.p-value: <0.001ANOVA
Comparison: Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.p-value: >0.1ANOVA
Secondary
Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention
The investigators will compare alpha oscillation power from resting state EEG recordings on the first day of stimulation (baseline) and at the follow-up visit four weeks after completion of the intervention. The investigators will also collect EEG on the fifth day of stimulation. The investigators will use each of the three EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers. As the stimulation paradigm stimulates the frontal brain regions, the investigators will analyze alpha power change in all brain regions as well as frontal regions.
Time frame: Baseline to F2
Population: Only participants that completed all sessions are used in this task (per protocol participants); N = 26
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| tACS (Alpha) | Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention | All Brain Regions | -0.42 decibel (dB) | Standard Deviation 2.35 |
| tACS (Alpha) | Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention | Frontal Brain Regions | -0.57 decibel (dB) | Standard Deviation 1.89 |
| tACS (Gamma) | Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention | All Brain Regions | 0.09 decibel (dB) | Standard Deviation 1.76 |
| tACS (Gamma) | Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention | Frontal Brain Regions | 0.00 decibel (dB) | Standard Deviation 1.6 |
| Sham Stimulation | Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention | All Brain Regions | 0.55 decibel (dB) | Standard Deviation 1.17 |
| Sham Stimulation | Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention | Frontal Brain Regions | 0.41 decibel (dB) | Standard Deviation 1.18 |
Comparison: Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG 4 weeks after completion of the intervention between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG 4 weeks after completion of the intervention between treatment groups.p-value: >0.1ANOVA
Other Pre-specified
Change in Beck Depression Inventory (BDI) Score
This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). Higher scores indicate more depressive symptoms. Total score is out of 63 possible. The investigators will compare the scores between baseline and F2. In these results, negative values indicate a decrease in depressive symptoms.
Time frame: Baseline to Day 5; Baseline to F2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| tACS (Alpha) | Change in Beck Depression Inventory (BDI) Score | Day 5 Change | -8.60 units on a scale | Standard Deviation 6.42 |
| tACS (Alpha) | Change in Beck Depression Inventory (BDI) Score | F2 change | -14.80 units on a scale | Standard Deviation 12.39 |
| tACS (Gamma) | Change in Beck Depression Inventory (BDI) Score | Day 5 Change | -9.64 units on a scale | Standard Deviation 10.07 |
| tACS (Gamma) | Change in Beck Depression Inventory (BDI) Score | F2 change | -11.09 units on a scale | Standard Deviation 11.68 |
| Sham Stimulation | Change in Beck Depression Inventory (BDI) Score | Day 5 Change | -7.18 units on a scale | Standard Deviation 7.19 |
| Sham Stimulation | Change in Beck Depression Inventory (BDI) Score | F2 change | -10.64 units on a scale | Standard Deviation 10.39 |
Other Pre-specified
Change in Hamilton Depression Rating Scale (HDRS) Score
The HDRS is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome. This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). The investigators will compare the scores between baseline and F2, with negative values indicating a decrease in depressive symptoms.
Time frame: Baseline to Day 5 of Stimulation; Baseline to F2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| tACS (Alpha) | Change in Hamilton Depression Rating Scale (HDRS) Score | Day 5 change | -6.00 units on a scale | Standard Deviation 3.09 |
| tACS (Alpha) | Change in Hamilton Depression Rating Scale (HDRS) Score | F2 change | -8.50 units on a scale | Standard Deviation 5.04 |
| tACS (Gamma) | Change in Hamilton Depression Rating Scale (HDRS) Score | Day 5 change | -4.45 units on a scale | Standard Deviation 5.41 |
| tACS (Gamma) | Change in Hamilton Depression Rating Scale (HDRS) Score | F2 change | -4.73 units on a scale | Standard Deviation 5.61 |
| Sham Stimulation | Change in Hamilton Depression Rating Scale (HDRS) Score | Day 5 change | -3.09 units on a scale | Standard Deviation 4.48 |
| Sham Stimulation | Change in Hamilton Depression Rating Scale (HDRS) Score | F2 change | -4.64 units on a scale | Standard Deviation 6.98 |
Other Pre-specified
Change in Montreal Cognitive Assessment (MoCA) Score
This measurement will be taken at baseline (first day of stimulation) and four weeks after completion of the intervention (F2). Total score ranges from 0 to 30, with higher values indicating better cognition. The investigators will compare the scores between baseline and F2. Reported values are the raw change (increase or decrease) from baseline.
Time frame: Baseline to F2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tACS (Alpha) | Change in Montreal Cognitive Assessment (MoCA) Score | 0.50 units on a scale | Standard Deviation 0.53 |
| tACS (Gamma) | Change in Montreal Cognitive Assessment (MoCA) Score | 1.27 units on a scale | Standard Deviation 1.35 |
| Sham Stimulation | Change in Montreal Cognitive Assessment (MoCA) Score | 1.09 units on a scale | Standard Deviation 1.51 |
Other Pre-specified
Clinical Global Impressions (CGI) Raw Score
This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). The investigators will compare the scores between baseline and F2.The reported values are from Item 1 Severity of Illness on a likert scale of 1 to 7, with 1=Normal, not at all ill and 7 = Among the most extremely ill patients.
Time frame: Day 5; F2 (4 weeks after completion of treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| tACS (Alpha) | Clinical Global Impressions (CGI) Raw Score | Day 5 Score | 4.30 units on a scale | Standard Deviation 0.95 |
| tACS (Alpha) | Clinical Global Impressions (CGI) Raw Score | F2 Score | 3.90 units on a scale | Standard Deviation 1.37 |
| tACS (Gamma) | Clinical Global Impressions (CGI) Raw Score | Day 5 Score | 3.73 units on a scale | Standard Deviation 0.65 |
| tACS (Gamma) | Clinical Global Impressions (CGI) Raw Score | F2 Score | 3.82 units on a scale | Standard Deviation 0.75 |
| Sham Stimulation | Clinical Global Impressions (CGI) Raw Score | Day 5 Score | 3.73 units on a scale | Standard Deviation 0.79 |
| Sham Stimulation | Clinical Global Impressions (CGI) Raw Score | F2 Score | 3.45 units on a scale | Standard Deviation 1.29 |