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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed-loop tACS | Experimental | Closed-loop individual alpha tACS daily for five consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed-loop tACS | Device | Individual alpha tACS |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 to Day 19 (i.e. 19 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 to Day 5 (i.e., 5 days) |
| Response/Remission of Depression |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Alpha Oscillation Power | Change in EEG alpha oscillation power at D1 pre-stimulation, D1 post-stimulation, and FU2. | 19 days |
| Change in Quick Inventory of Depressive Symptomatology (QIDS) Over 12 Weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R Rubinow, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolina Center for Neurostimulation | Chapel Hill | North Carolina | 27516 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30837453 | Background | Alexander ML, Alagapan S, Lugo CE, Mellin JM, Lustenberger C, Rubinow DR, Frohlich F. Double-blind, randomized pilot clinical trial targeting alpha oscillations with transcranial alternating current stimulation (tACS) for the treatment of major depressive disorder (MDD). Transl Psychiatry. 2019 Mar 5;9(1):106. doi: 10.1038/s41398-019-0439-0. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Closed-loop tACS | Closed-loop individual alpha tACS daily for five consecutive days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Closed-loop tACS | Closed-loop individual alpha tACS daily for five consecutive days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Day 1 to Day 19 (i.e. 19 days) |
|
|
Adverse event data were collected across the full study participation (89 days). A structured adverse event was administered on D5 for all participants and for any AE spontaneously reported by a participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Closed-loop tACS | Closed-loop individual alpha tACS daily for five consecutive days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Nausea, time-limited to the stimulation session |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Walker | Pulvinar Neuro | 8043173403 | chris.walker@pulvinarneuro.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 16, 2024 | Apr 21, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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Open-Label
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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. |
| Day 5 and Day 19 |
| 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. | Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2) |
| 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. | Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2) |
| 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. | Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2) |
| 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. | Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2) |
| 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. | Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2) |
| 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. | Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2) |
| 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. | Severity: {Day 1 (D1), Day 5 (D5) and Day 19 (FU2)}; Global Improvement: {Day 5 (D5) and Day 19 (FU2)} |
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.
| 89 days |
| 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. | 89 days |
| 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. | 89 days |
| 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. | 89 days |
| 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. | 89 days |
| 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. | 89 days |
| HDRS-17 Change | Change in HDRS-17 between six week follow up (FU4) and D1 | 47 Days |
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline HDRS-17 Score | Baseline HDRS-17 (Hamilton Depression Rating Scale, 17-item) score on Day 1 (D1) of treatment week prior to receiving treatment; minimum value is 0, maximum value is 52. Higher scores indicate worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Baseline QIDS Score | Baseline QIDS (Quick Inventory of Depressive Symptomatology) score on Day 1 (D1) of treatment week prior to receiving treatment; minimum value is 0, maximum value is 27. Higher scores indicate worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Baseline Q-LES-Q-SF Score | Baseline Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form) on day 1 (D1); minimum value is 14, maximum value is 70. Higher scores indicate better outcome. | Mean | Standard Deviation | units on a scale |
|
| Baseline ASRM Score | Baseline ASRM (Altman Self-Rating Mania Scale) on day 1 (D1); minimum value is 0, maximum value is 20. Higher scores indicate worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Baseline SHAPS Score | Baseline SHAPS (Snaith-Hamilton Pleasure Scale) score on day 1 (D1); minimum value is 0, maximum value is 14. Higher scores indicate worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Baseline DASS-42 Score | Baseline DASS-42 (Depression, Anxiety, and Stress Scale, 42-item) on day 1 (D1); minimum value is 0, maximum value is 126 with three subscales (0 to 42). Higher scores indicate worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Baseline STAI Score | Baseline STAI (State-Trait Anxiety Inventory (state score)) on day 1 (D1); minimum value is 20, maximum value is 80. Higher scores indicate worse outcome. | Mean | Standard Deviation | units on a scale |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 to Day 5 (i.e., 5 days) |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | Day 5 and Day 19 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2) |
|
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|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Severity: {Day 1 (D1), Day 5 (D5) and Day 19 (FU2)}; Global Improvement: {Day 5 (D5) and Day 19 (FU2)} |
|
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|
|
| Other Pre-specified | Change in Alpha Oscillation Power | Change in EEG alpha oscillation power at D1 pre-stimulation, D1 post-stimulation, and FU2. | Not Posted | 19 days | Participants |
| 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. | Not Posted | 89 days | Participants |
| 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. | Not Posted | 89 days | Participants |
| 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. | Not Posted | 89 days | Participants |
| 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. | Not Posted | 89 days | Participants |
| 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. | Not Posted | 89 days | Participants |
| 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. | Not Posted | 89 days | Participants |
| Other Pre-specified | HDRS-17 Change | Change in HDRS-17 between six week follow up (FU4) and D1 | Not Posted | 47 Days | Participants |
| 0 |
| 26 |
| 0 |
| 26 |
| 21 |
| 26 |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | Vomiting, time-limited to the stimulation session, determined by study physician to likely be related to participant's undisclosed COVID-19 infection. |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Diarrhea reported during the treatment week |
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| Headache | Nervous system disorders | Systematic Assessment | Headache, time-limited to the stimulation session |
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| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin irritation at electrode sites, time-limited to the stimulation session |
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| Scalp/neck pain | General disorders | Systematic Assessment | Scalp/neck pain, time-limited to the stimulation session |
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| Dizziness | Nervous system disorders | Systematic Assessment | Dizziness, time-limited to the stimulation session |
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| Fatigue | General disorders | Systematic Assessment | Fatigue, increased tiredness time-limited to the stimulation session |
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| Muscle cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment | Muscle cramps, time-limited to the stimulation session |
|
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| D001523 |
| Mental Disorders |
| Did not meet criteria |
|
| Remission at D5 |
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| Remission at FU2 |
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| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Depression Subscale: D5-D1 |
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| Depression Subscale: FU1-D1 |
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| Depression Subscale: FU2-D1 |
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| Anxiety Subscale: D5-D1 |
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| Anxiety Subscale: FU1-D1 |
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| Anxiety Subscale: FU2-D1 |
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| Stress Subscale: D5-D1 |
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| Stress Subscale: FU1-D1 |
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| Stress Subscale: FU2-D1 |
|
| 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 = FU2 | ANOVA | This subscale did not require sphericity corrections. | <0.0005 | Other | This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels. |
| 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 = FU2 | ANOVA | Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied. | <0.0005 | Other | This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels. |
| 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 = FU2 | ANOVA | Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied. | <0.0005 | Other | This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels. |
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Severity at D5 |
|
| Severity at FU2 |
|
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 = FU2 |
| t-test, 2 sided |
| 0.006 |
| Other |
This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels. |