Depression, Major Depressive Disorder, tACS
Conditions
Brief summary
The purpose of this research study is to study closed-loop transcranial alternating current stimulation (tACS) to determine its effects on symptoms of depression in people with major depressive disorder.
Detailed description
The purpose of this clinical trial is to investigate the preliminary efficacy of closed-loop tACS for the treatment of major depressive disorder (MDD) in an open-label pilot study. We will recruit up to 35 participants with unipolar, non-psychotic MDD. Participation will include seven visits, two of them remotely (with an in-person option as needed), and one electronic survey. Potential participants fill-in an electronic pre-screening form. If potentially eligible, a remote screening visit is performed. If eligible, participants attend five consecutive, daily stimulation sessions. Clinical assessments will be performed at baseline (Day 1 of stimulation, D1), Day five of stimulation (D5), and at their follow-up visit (14 days after the completion of stimulation, FU2) using the Hamilton Depression Rating Scale (HDRS-17). For a subset of patients, electroencephalography (EEG) is collected at D1 prior to stimulation and after stimulation and again at FU2. For a subset of patients, self-scoring surveys will be sent bi-weekly until 12 weeks after treatment.
Interventions
DEVICEClosed-loop tACS
Individual alpha tACS
Sponsors
University of North Carolina, Chapel Hill
Electromedical Products International, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-Label
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Ages 18-70 years * Diagnostic and Statistical Manual, 5th Edition (DSM-5) diagnosis of MDD; unipolar, non-psychotic * Hamilton Rating Depression Rating Scale (HRDS-17) score \>8 * Low suicide risk as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) triage form (no intent or plan) * Capacity to understand all relevant risks and potential benefits of the study (informed consent)
Exclusion criteria
* DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months. * DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months. * Lifetime history of bipolar disorder, psychotic disorder, schizophrenia, autism * Current use of benzodiazepines \> 20mg diazepam/d equivalent * Antidepressant dose change within the last 2 weeks * Initiated new antidepressant within the last 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Depression Rating Scale 17-item (HDRS-17) | Day 1 to Day 19 (i.e. 19 days) | Change in HDRS-17 from Day 1 (D1) to Day 19 (i.e., two week follow-up; FU2); HDRS-17 minimum value is 0, maximum value is 52. Higher scores indicate worse outcome. Negative scores indicate improved outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response/Remission of Depression | Day 5 and Day 19 | Number of response/remission rates at Day 5 (D5) and Day 19 (i.e., two week follow-up; FU2). Response defined as \>=50% reduction in HDRS-17 from D1. Remission defined as HDRS-17 score \<=7. |
| Change in Hamilton Depression Rating Scale 17-item (HDRS-17) | Day 1 to Day 5 (i.e., 5 days) | Change in HDRS-17 from Day 1 (D1) to Day 5 (D5); HDRS-17minimum value is 0, maximum value is 52. Higher scores indicate worse outcome. Negative scores indicate improved outcomes. |
| Change in Quick Inventory of Depressive Symptomatology (QIDS) | Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2) | Change in QIDS at Day 5 (D5), Day 12 (i.e., one-week follow-up; FU1), and Day 19 (i.e., two-week follow-up; FU2); QIDS minimum value is 0, maximum value is 27. Higher scores indicate worse outcome. Negative scores indicate improved outcome. |
| Change in Altman Self-Rating Mania Scale (ASRM) | Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2) | Change in ASRM at Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); ASRM minimum value is 0, maximum value is 20. Higher scores indicate worse outcome. Negative scores indicate improved outcome. |
| Change in Snaith-Hamilton Pleasure Scale (SHAPS) | Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2) | Change in SHAPS from Day 1 (D1) to Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); SHAPS minimum value is 0, maximum value is 14. Higher scores indicate worse outcome. Negative scores indicate improved outcome. |
| Change in Depression Anxiety and Stress Scale (DASS-42) | Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2) | Change in DASS-42 from Day 1 (D1) to Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); DASS-42 minimum value is 0, maximum value is 126 with three subscales (0 to 42). Higher scores indicate worse outcome. Negative scores indicate improved outcome. |
| Change in State-Train Anxiety Inventory (STAI) | Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2) | Change in STAI from Day 1 (D1) to Day 5 (D5), Day 12 (one week follow-up; FU1), and Day 19 (two week follow-up; FU2); STAI minimum value is 20, maximum value is 80. Higher scores indicate worse outcome. Negative scores indicate improved outcome. |
| Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) | Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2) | Change in Q-LES-Q-SF from Day 1 (D1) to Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); Q-LES-Q-SF minimum value is 14, maximum value is 70. Higher scores indicate better outcome. Negative scores indicate worse outcome. |
| Change in Clinical Global Impression Scale (CGI) | Severity: {Day 1 (D1), Day 5 (D5) and Day 19 (FU2)}; Global Improvement: {Day 5 (D5) and Day 19 (FU2)} | Change in CGI from Day 1 (D1) to Day 5 (D5) and Day 19 (i.e., two week follow-up; FU2); CGI scale contains two scoring components, 1) Severity of Illness (0-7) and 2) Global Improvement (0-7). Higher scores in component 1 indicate worse symptoms while higher numbers in component 2 indicate worse clinical outcomes. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Altman Self-Rating Mania Scale (ASRM) Over 12 Weeks | 89 days | Change in ASRM at FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 20. Higher scores indicate worse outcome. |
| Change in Snaith-Hamilton Pleasure Scale (SHAPS) Over 12 Weeks | 89 days | Change in SHAPS at FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 14. Higher scores indicate worse outcome. |
| Change in Depression Anxiety and Stress Scale (DASS-42) Over 12 Weeks | 89 days | Change in DASS-42 at FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 126 with three subscales (0 to 42). Higher scores indicate worse outcome. |
| Change in State-Train Anxiety Inventory (STAI) Over 12 Weeks | 89 days | Change in STAI at FU3, FU4, FU5, FU6, and FU7; minimum value is 20, maximum value is 80. Higher scores indicate worse outcome. |
| Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) | 89 days | Change in Q-LES-Q-SF at FU3, FU4, FU5, FU6, and FU7; minimum value is 14, maximum value is 70. Higher scores indicate better outcome. |
| HDRS-17 Change | 47 Days | Change in HDRS-17 between six week follow up (FU4) and D1 |
| Change in Quick Inventory of Depressive Symptomatology (QIDS) Over 12 Weeks | 89 days | Change in QIDS at four week follow-up (FU3), six week follow-up (FU4), eight week follow-up (FU5), ten week follow-up (FU6), and twelve week follow-up (FU7); minimum value is 0, maximum value is 27. Higher scores indicate worse outcome. |
| Change in Alpha Oscillation Power | 19 days | Change in EEG alpha oscillation power at D1 pre-stimulation, D1 post-stimulation, and FU2. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Closed-loop tACS Closed-loop individual alpha tACS daily for five consecutive days. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Closed-loop tACS |
|---|---|
| Age, Continuous | 40.1 Years STANDARD_DEVIATION 15 |
| Baseline ASRM Score | 1.16 units on a scale STANDARD_DEVIATION 1.28 |
| Baseline DASS-42 Score Anxiety Subscale | 6.48 units on a scale STANDARD_DEVIATION 4.09 |
| Baseline DASS-42 Score Depression Subscale | 23.12 units on a scale STANDARD_DEVIATION 6.31 |
| Baseline DASS-42 Score Overall Score | 45.96 units on a scale STANDARD_DEVIATION 14.42 |
| Baseline DASS-42 Score Stress Subscale | 16.36 units on a scale STANDARD_DEVIATION 9.34 |
| Baseline HDRS-17 Score | 17.18 units on a scale STANDARD_DEVIATION 4.19 |
| Baseline QIDS Score | 14.72 units on a scale STANDARD_DEVIATION 2.67 |
| Baseline Q-LES-Q-SF Score | 37.44 units on a scale STANDARD_DEVIATION 5.12 |
| Baseline SHAPS Score | 5.52 units on a scale STANDARD_DEVIATION 3.27 |
| Baseline STAI Score | 47.88 units on a scale STANDARD_DEVIATION 10.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex/Gender, Customized Female | 20 Participants |
| Sex/Gender, Customized Gender nonconforming | 1 Participants |
| Sex/Gender, Customized Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 21 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
Change in Hamilton Depression Rating Scale 17-item (HDRS-17)
Change in HDRS-17 from Day 1 (D1) to Day 19 (i.e., two week follow-up; FU2); HDRS-17 minimum value is 0, maximum value is 52. Higher scores indicate worse outcome. Negative scores indicate improved outcomes.
Time frame: Day 1 to Day 19 (i.e. 19 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed-loop tACS | Change in Hamilton Depression Rating Scale 17-item (HDRS-17) | -12.04 units on a scale | Standard Deviation 4.83 |
Comparison: HDRS-17 change score were submitted to a t-test to estimate the group difference from 0 (i.e., no change in depression symptoms from D1 to FU2). Null hypothesis: D1 == FU2p-value: <0.0005t-test, 2 sided
Secondary
Change in Altman Self-Rating Mania Scale (ASRM)
Change in ASRM at Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); ASRM minimum value is 0, maximum value is 20. Higher scores indicate worse outcome. Negative scores indicate improved outcome.
Time frame: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-loop tACS | Change in Altman Self-Rating Mania Scale (ASRM) | D5-D1 | 0.88 score on a scale | Standard Deviation 1.81 |
| Closed-loop tACS | Change in Altman Self-Rating Mania Scale (ASRM) | FU1-D1 | 1.92 score on a scale | Standard Deviation 1.93 |
| Closed-loop tACS | Change in Altman Self-Rating Mania Scale (ASRM) | FU2-D1 | 1.92 score on a scale | Standard Deviation 1.89 |
Comparison: ASRM scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 ASRM surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2p-value: <0.0005ANOVA
Secondary
Change in Clinical Global Impression Scale (CGI)
Change in CGI from Day 1 (D1) to Day 5 (D5) and Day 19 (i.e., two week follow-up; FU2); CGI scale contains two scoring components, 1) Severity of Illness (0-7) and 2) Global Improvement (0-7). Higher scores in component 1 indicate worse symptoms while higher numbers in component 2 indicate worse clinical outcomes.
Time frame: Severity: {Day 1 (D1), Day 5 (D5) and Day 19 (FU2)}; Global Improvement: {Day 5 (D5) and Day 19 (FU2)}
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-loop tACS | Change in Clinical Global Impression Scale (CGI) | Global Improvement at D5 | 2.56 units on a scale | Standard Deviation 1.16 |
| Closed-loop tACS | Change in Clinical Global Impression Scale (CGI) | Global Improvement at FU2 | 1.68 units on a scale | Standard Deviation 0.75 |
| Closed-loop tACS | Change in Clinical Global Impression Scale (CGI) | Severity at D1 | 4.04 units on a scale | Standard Deviation 0.79 |
| Closed-loop tACS | Change in Clinical Global Impression Scale (CGI) | Severity at D5 | 2.36 units on a scale | Standard Deviation 1.19 |
| Closed-loop tACS | Change in Clinical Global Impression Scale (CGI) | Severity at FU2 | 1.76 units on a scale | Standard Deviation 0.93 |
Comparison: CGI severity scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 CGI assessments were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU2p-value: <0.0005ANOVA
Comparison: CGI improvement scores were submitted to a paired t-test to measure difference between the improvement assessment on D5 and the assessment at FU2. Note: D5 CGI assessments were completed prior to receiving the final treatment on D5. Null hypothesis: D5 = FU2p-value: 0.006t-test, 2 sided
Secondary
Change in Depression Anxiety and Stress Scale (DASS-42)
Change in DASS-42 from Day 1 (D1) to Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); DASS-42 minimum value is 0, maximum value is 126 with three subscales (0 to 42). Higher scores indicate worse outcome. Negative scores indicate improved outcome.
Time frame: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-loop tACS | Change in Depression Anxiety and Stress Scale (DASS-42) | Overall: D5-D1 | -12.52 score on a scale | Standard Deviation 14.39 |
| Closed-loop tACS | Change in Depression Anxiety and Stress Scale (DASS-42) | Overall: FU1-D1 | -21.44 score on a scale | Standard Deviation 16.63 |
| Closed-loop tACS | Change in Depression Anxiety and Stress Scale (DASS-42) | Overall: FU2-D1 | -24.08 score on a scale | Standard Deviation 18.92 |
| Closed-loop tACS | Change in Depression Anxiety and Stress Scale (DASS-42) | Depression Subscale: D5-D1 | -6.52 score on a scale | Standard Deviation 8.15 |
| Closed-loop tACS | Change in Depression Anxiety and Stress Scale (DASS-42) | Depression Subscale: FU1-D1 | -11.00 score on a scale | Standard Deviation 7.53 |
| Closed-loop tACS | Change in Depression Anxiety and Stress Scale (DASS-42) | Depression Subscale: FU2-D1 | -12.20 score on a scale | Standard Deviation 8.9 |
| Closed-loop tACS | Change in Depression Anxiety and Stress Scale (DASS-42) | Anxiety Subscale: D5-D1 | -1.88 score on a scale | Standard Deviation 2.57 |
| Closed-loop tACS | Change in Depression Anxiety and Stress Scale (DASS-42) | Anxiety Subscale: FU1-D1 | -2.84 score on a scale | Standard Deviation 4.04 |
| Closed-loop tACS | Change in Depression Anxiety and Stress Scale (DASS-42) | Anxiety Subscale: FU2-D1 | -3.64 score on a scale | Standard Deviation 4.51 |
| Closed-loop tACS | Change in Depression Anxiety and Stress Scale (DASS-42) | Stress Subscale: D5-D1 | -4.12 score on a scale | Standard Deviation 6.73 |
| Closed-loop tACS | Change in Depression Anxiety and Stress Scale (DASS-42) | Stress Subscale: FU1-D1 | -7.60 score on a scale | Standard Deviation 8.99 |
| Closed-loop tACS | Change in Depression Anxiety and Stress Scale (DASS-42) | Stress Subscale: FU2-D1 | -8.24 score on a scale | Standard Deviation 9.47 |
Comparison: DASS-42 OVERALL scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2p-value: <0.0005ANOVA
Comparison: DASS-42 DEPRESSION SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2p-value: <0.0005ANOVA
Comparison: DASS-42 ANXIETY SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2p-value: <0.0005ANOVA
Comparison: DASS-42 STRESS SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2p-value: <0.0005ANOVA
Secondary
Change in Hamilton Depression Rating Scale 17-item (HDRS-17)
Change in HDRS-17 from Day 1 (D1) to Day 5 (D5); HDRS-17minimum value is 0, maximum value is 52. Higher scores indicate worse outcome. Negative scores indicate improved outcomes.
Time frame: Day 1 to Day 5 (i.e., 5 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed-loop tACS | Change in Hamilton Depression Rating Scale 17-item (HDRS-17) | -8.36 score on a scale | Standard Deviation 4.41 |
Comparison: HDRS-17 change score were submitted to a t-test to estimate the group difference from 0 (i.e., no change in depression symptoms from D1 to D5). Note: D5 HDRS-17 were determined prior to receiving the final treatment on D5. Null hypothesis: D1 == D5p-value: <0.0005t-test, 2 sided
Secondary
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF)
Change in Q-LES-Q-SF from Day 1 (D1) to Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); Q-LES-Q-SF minimum value is 14, maximum value is 70. Higher scores indicate better outcome. Negative scores indicate worse outcome.
Time frame: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-loop tACS | Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) | D5-D1 | 6.86 score on a scale | Standard Deviation 12.58 |
| Closed-loop tACS | Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) | FU1-D1 | 15.36 score on a scale | Standard Deviation 11.34 |
| Closed-loop tACS | Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) | FU2-D1 | 16.57 score on a scale | Standard Deviation 13.56 |
Comparison: QIDS scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 QIDS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2p-value: <0.0005ANOVA
Secondary
Change in Quick Inventory of Depressive Symptomatology (QIDS)
Change in QIDS at Day 5 (D5), Day 12 (i.e., one-week follow-up; FU1), and Day 19 (i.e., two-week follow-up; FU2); QIDS minimum value is 0, maximum value is 27. Higher scores indicate worse outcome. Negative scores indicate improved outcome.
Time frame: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-loop tACS | Change in Quick Inventory of Depressive Symptomatology (QIDS) | D5-D1 | -3.88 score on a scale | Standard Deviation 3.23 |
| Closed-loop tACS | Change in Quick Inventory of Depressive Symptomatology (QIDS) | FU1-D1 | -5.96 score on a scale | Standard Deviation 3.51 |
| Closed-loop tACS | Change in Quick Inventory of Depressive Symptomatology (QIDS) | FU2-D1 | -7.48 score on a scale | Standard Deviation 3.9 |
Comparison: QIDS change score were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 QIDS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2p-value: <0.0005ANOVA
Secondary
Change in Snaith-Hamilton Pleasure Scale (SHAPS)
Change in SHAPS from Day 1 (D1) to Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); SHAPS minimum value is 0, maximum value is 14. Higher scores indicate worse outcome. Negative scores indicate improved outcome.
Time frame: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-loop tACS | Change in Snaith-Hamilton Pleasure Scale (SHAPS) | D5-D1 | -2.60 score on a scale | Standard Deviation 2.61 |
| Closed-loop tACS | Change in Snaith-Hamilton Pleasure Scale (SHAPS) | FU1-D1 | -3.48 score on a scale | Standard Deviation 3.4 |
| Closed-loop tACS | Change in Snaith-Hamilton Pleasure Scale (SHAPS) | FU2-D1 | -3.76 score on a scale | Standard Deviation 3.44 |
Comparison: SHAPS scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 SHAPS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2p-value: <0.0005ANOVA
Secondary
Change in State-Train Anxiety Inventory (STAI)
Change in STAI from Day 1 (D1) to Day 5 (D5), Day 12 (one week follow-up; FU1), and Day 19 (two week follow-up; FU2); STAI minimum value is 20, maximum value is 80. Higher scores indicate worse outcome. Negative scores indicate improved outcome.
Time frame: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-loop tACS | Change in State-Train Anxiety Inventory (STAI) | D5-D1 | -3.08 score on a scale | Standard Deviation 10.03 |
| Closed-loop tACS | Change in State-Train Anxiety Inventory (STAI) | FU1-D1 | -5.16 score on a scale | Standard Deviation 10.35 |
| Closed-loop tACS | Change in State-Train Anxiety Inventory (STAI) | FU2-D1 | -6.16 score on a scale | Standard Deviation 12.29 |
Comparison: STAI scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 STAI surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2p-value: 0.021ANOVA
Secondary
Response/Remission of Depression
Number of response/remission rates at Day 5 (D5) and Day 19 (i.e., two week follow-up; FU2). Response defined as \>=50% reduction in HDRS-17 from D1. Remission defined as HDRS-17 score \<=7.
Time frame: Day 5 and Day 19
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Closed-loop tACS | Response/Remission of Depression | Response at D5 | Met criteria | 12 Participants |
| Closed-loop tACS | Response/Remission of Depression | Response at D5 | Did not meet criteria | 13 Participants |
| Closed-loop tACS | Response/Remission of Depression | Response at FU2 | Met criteria | 21 Participants |
| Closed-loop tACS | Response/Remission of Depression | Response at FU2 | Did not meet criteria | 4 Participants |
| Closed-loop tACS | Response/Remission of Depression | Remission at D5 | Met criteria | 10 Participants |
| Closed-loop tACS | Response/Remission of Depression | Remission at D5 | Did not meet criteria | 15 Participants |
| Closed-loop tACS | Response/Remission of Depression | Remission at FU2 | Met criteria | 21 Participants |
| Closed-loop tACS | Response/Remission of Depression | Remission at FU2 | Did not meet criteria | 4 Participants |
Other Pre-specified
Change in Alpha Oscillation Power
Change in EEG alpha oscillation power at D1 pre-stimulation, D1 post-stimulation, and FU2.
Time frame: 19 days
Other Pre-specified
Change in Altman Self-Rating Mania Scale (ASRM) Over 12 Weeks
Change in ASRM at FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 20. Higher scores indicate worse outcome.
Time frame: 89 days
Other Pre-specified
Change in Depression Anxiety and Stress Scale (DASS-42) Over 12 Weeks
Change in DASS-42 at FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 126 with three subscales (0 to 42). Higher scores indicate worse outcome.
Time frame: 89 days
Other Pre-specified
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF)
Change in Q-LES-Q-SF at FU3, FU4, FU5, FU6, and FU7; minimum value is 14, maximum value is 70. Higher scores indicate better outcome.
Time frame: 89 days
Other Pre-specified
Change in Quick Inventory of Depressive Symptomatology (QIDS) Over 12 Weeks
Change in QIDS at four week follow-up (FU3), six week follow-up (FU4), eight week follow-up (FU5), ten week follow-up (FU6), and twelve week follow-up (FU7); minimum value is 0, maximum value is 27. Higher scores indicate worse outcome.
Time frame: 89 days
Other Pre-specified
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Over 12 Weeks
Change in SHAPS at FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 14. Higher scores indicate worse outcome.
Time frame: 89 days
Other Pre-specified
Change in State-Train Anxiety Inventory (STAI) Over 12 Weeks
Change in STAI at FU3, FU4, FU5, FU6, and FU7; minimum value is 20, maximum value is 80. Higher scores indicate worse outcome.
Time frame: 89 days
Other Pre-specified
HDRS-17 Change
Change in HDRS-17 between six week follow up (FU4) and D1
Time frame: 47 Days