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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH101282 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to develop external Trigeminal Nerve Stimulation (eTNS) as a potential nonmedication treatment for attention-deficit/hyperactivity disorder (ADHD).
Study hypothesis address potential differences over 4 weeks of active vs. sham eTNS treatment on ADHD symptoms, measures of executive function, electroencephalography (EEG) profiles, other dimensional measures of height, weight, mood, anxiety, and sleep, and side effect profiles.
This three-year developmental study is a double-blind randomized trial of active vs. inactive sham eTNS for ADHD, with four weeks acute treatment followed by an additional one week of clinical observation and testing after treatment cessation.
The study will enroll 85-90 participants aged 8-12 years to achieve a completion target of N=36 for each study condition (total final N = 72). Participants will meet Diagnostic and Statistical Manual-5 (DSM-5) criteria for ADHD, any current presentation, as established by the Behavior Disorders Module of the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL) and clinical interview.
Other screening procedures include measures of ADHD symptom severity, other behavioral ratings, and cognitive assessments. Once inclusion/exclusion criteria have been reviewed and verified, participants in Phase 1A will have a pre-treatment visit to establish behavioral and cognitive baseline ratings and to obtain an EEG. Participants and parents will be instructed in the use of eTNS, and participants will begin use of the eTNS as directed during sleep each night. Participants will be randomized 1:1 to active or inactive sham eTNS. Participants, families, and most of the study team will remain blind to treatment assignment. Participants will have weekly assessments over the five-week study to assess behavioral, cognitive, and brain activation change and to monitor safety, tolerability, and compliance. Weekly ratings will be obtained from a parent, teacher, and clinician investigator. EEG will occur at baseline, end of treatment (week 4).
In Phase 1B, all participants remain blinded for one week after cessation of the intervention and return for a final visit to assess residual effects of eTNS therapy vs. sham.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active eTNS | Experimental | Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Positive responders will be invited to participate in a 12-month open extension. |
|
| Sham eTNS | Sham Comparator | Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Following double-blind phase, interested participants randomized to sham have an option for a 4-week open TNS trial. Positive responders will be invited to participate in a 12-month open extension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active eTNS | Device | Participants will receive active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. Participant deemed to be positive responders to blinded active treatment will be invited to continue open eTNS in a 12 month extension period. |
| Measure | Description | Time Frame |
|---|---|---|
| ADHD-IV Rating Scale (ADHD-RS) | A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity. | Change over baseline and weeks 1, 2, 3, 4 and 5. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression - Improvement (CGI-I) | Categorical measure indicating degree improved or not improved compared with baseline for each treatment group. Minimum score = 1 (very much improved); Maximum score = 7 (very much worse). Results reflect number of participants stratified as "Improved" (CGI-I <=2) or "Not Improved" (CGI-I > 2). | Change over weeks 1, 2, 3, 4, and 5 compared with baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Affective Posner Task | A laboratory measure of frustration tolerance. | Baseline, and Weeks 1 and 4 |
| Attention Network Task (ANT) Response Inhibition | A computer-administered laboratory measure of executive function. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James J McGough, M.D. | University of California, Los Angeles | Principal Investigator |
| Sandra K Loo, Ph.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Semel Institute | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30768393 | Result | McGough JJ, Sturm A, Cowen J, Tung K, Salgari GC, Leuchter AF, Cook IA, Sugar CA, Loo SK. Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2019 Apr;58(4):403-411.e3. doi: 10.1016/j.jaac.2018.11.013. Epub 2019 Jan 28. | |
| 33068751 | Derived | Loo SK, Salgari GC, Ellis A, Cowen J, Dillon A, McGough JJ. Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder: Cognitive and Electroencephalographic Predictors of Treatment Response. J Am Acad Child Adolesc Psychiatry. 2021 Jul;60(7):856-864.e1. doi: 10.1016/j.jaac.2020.09.021. Epub 2020 Oct 15. |
| Label | URL |
|---|---|
| Pub Med Abstract | View source |
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Potential participants underwent screening and those eligible returned for baseline assessment and randomization. Of 79 individuals screened, 64 met inclusion/exclusion criteria for participation. Two of these chose not to return after screening, most likely because they were only interested in ADHD assessment.
Participants enrolled between 04/2015 and 03/2017. Participants were recruited through community advertisements and internet postings.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active TNS | Active TNS Active TNS: Participants randomized to active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep. |
| FG001 | Sham TNS | Sham TNS Sham TNS: Participants randomized to sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1a: 4 Week Double Blind Sham Controlled |
|
| ||||||||||||||||||
| 1b: 1 Week Blinded Post Treatment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active eTNS | Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Active eTNS: Participants will receive active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. Participant deemed to be positive responders to blinded active treatment will be invited to continue open eTNS in a 12 month extension period. |
| 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 | ADHD-IV Rating Scale (ADHD-RS) | A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity. | Data missing for some visits. | Posted | Least Squares Mean | Standard Error | score on a scale | Change over baseline and weeks 1, 2, 3, 4 and 5. |
|
Data were collected over the double-blind study, beginning at baseline and then weekly for 5 weeks.
Adverse events were solicited via a structured side effects questionnaire and open inquiry completed at baseline and each weekly visit during the double-blind phases.
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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 | Active TNS | Active TNS Active TNS: Participants randomized to active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Trouble sleeping | Psychiatric disorders | Systematic Assessment |
Insufficient data were collected with the Conners Teacher Report leading to small number of participants analyzed. Results are likely not valid.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James McGough, M.D. | University of California, Los Angeles | 310-794-7841 | jmcgough@mednet.ucla.edu |
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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 | May 30, 2018 | Feb 26, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 28, 2015 | Mar 21, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Double-blind, sham-controlled.
|
|
| Sham eTNS | Device | Participants will receive sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. At the conclusion of the blinded trial, participants randomized to the sham group will be offered 4 weeks of open eTNS treatment. Participants deemed to be positive responders to open treatment will be invited to continue open nightly eTNS in a 12 month extension period. |
|
| Conners Global Index - Parent Report | Parent completed dimensional measure of ADHD symptoms, with score range from 0- 30, and higher scores indicating more severe symptoms. | Change over baseline and weeks 1, 2, 3, 4, 5. |
| Affective Reactivity Index (ARI) - Child | A child completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity. | Change over baseline and weeks 4 and 5. |
| Affective Reactivity Index (ARI) - Parent Report | A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity. | Change over baseline and weeks 4 and 5. |
| Multidimensional Anxiety Scale for Children (MASC) - Child Report | A child completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity. | Change over baseline and weeks 4 and 5. |
| Multidimensional Anxiety Scale for Children (MASC) - Parent Report | A parent completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity. | Change over baseline and weeks 4 and 5. |
| Height | A dimensional measure assessed in centimeters (cm). | Change over baseline and weeks 1, 4, and 5. |
| Weight | A dimensional measure assessed in kilograms (kg). | Change over baseline and weeks 1, 4, and 5. |
| Systolic Blood Pressure | A dimensional measure expressed in mm mercury (Hg). | Change over baseline and weeks 1, 4, and 5. |
| Diastolic Blood Pressure | A dimensional measure assessed in mm mercury (Hg). | Change over baseline and weeks 1, 4, and 5. |
| Pulse | Heart rate in beats per minute (bpm). | Change over baseline and weeks weeks 1, 4, and 5. |
| Children's Depression Inventory (CDI) | A child completed self-report dimensional measure of depressive symptoms, with range of scores from 0 to 54. Higher scores reflect increasing depression. Cutoff scores < 17 to 20 are generally considered to be in the normative range. A score of 36 or higher reflects a relatively severe depression. | Change over baseline and weeks 4 and 5. |
| Conners Global Index - Teacher | Teacher completed dimensional measure of ADHD symptoms, with scores ranging from 0-30, and higher scores indicating more severe symptoms. | Change over baseline and weeks 1, 2, 3, 4, 5. |
| Baseline, Weeks 1 and 4 |
| Spatial Working Memory (SWM) | A computer-administered laboratory measure of executive function. | Baseline, Weeks 1 and 4 |
| Electroencephalography (EEG) | A laboratory measure of cortical activity. | Baseline and Week 4 |
| Behavior Rating Inventory of Executive Functioning (BRIEF) | A parent completed rating of child executive function. Comprises 5 sub scales that measure various measures of behavior and cognition. Raw scores on each measure are converted to T scores ranging from 28 to 103, with higher scores indicating greater difficulties. | Baseline, end of Weeks 4 and 5. |
| Children's Sleep Habits Questionnaire (CSHQ) | A parent completed 33-item scale to assess sleep related problems. Total scores range from 33 to 99 divided among 8 sub scales , with higher scores indicating more severe difficulties. | Weekly for double-blind trial. |
| NOT COMPLETED |
|
|
| BG001 | Sham eTNS | Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Sham eTNS: Participants will receive sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. At the conclusion of the blinded trial, participants randomized to the sham group will be offered 4 weeks of open eTNS treatment. Participants deemed to be positive responders to open treatment will be invited to continue open nightly eTNS in a 12 month extension period. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ADHD Subtype | Subtypes listed (Combined, Inattentive, Hyperactive/Impulsive) reflect different subtypes of ADHD according to diagnostic criteria. They do not reflect any grading or measure of severity. | Count of Participants | Participants |
|
| Full Scale IQ Estimate | Based on the Wechsler Abbreviated Scales of Intelligence, 3rd Edition. | Mean | Standard Deviation | IQ points |
|
| ADHD-Rating Scale Total Score | A dimensional rating of ADHD symptoms with scores ranging from 0 to 54, with higher scores indicating greater severity. | Mean | Standard Deviation | units on a scale |
|
| Clinical Global Impression - Severity | A categorical measure of severity ranging from 1 ("Normal, not at all ill") to 7 ("Among the most extremely ill patients."). | Count of Participants | Participants |
|
| OG001 | Sham eTNS | Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Following double-blind phase, interested participants randomized to sham have an option for a 4-week open TNS trial. Positive responders will be invited to participate in a 12-month open extension. Sham eTNS: Participants will receive sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. At the conclusion of the blinded trial, participants randomized to the sham group will be offered 4 weeks of open eTNS treatment. Participants deemed to be positive responders to open treatment will be invited to continue open nightly active eTNS in a 12 month extension period. |
|
|
|
| Secondary | Clinical Global Impression - Improvement (CGI-I) | Categorical measure indicating degree improved or not improved compared with baseline for each treatment group. Minimum score = 1 (very much improved); Maximum score = 7 (very much worse). Results reflect number of participants stratified as "Improved" (CGI-I <=2) or "Not Improved" (CGI-I > 2). | Data missing for some visits. | Posted | Count of Participants | Participants | Change over weeks 1, 2, 3, 4, and 5 compared with baseline. |
|
|
|
|
| Secondary | Conners Global Index - Parent Report | Parent completed dimensional measure of ADHD symptoms, with score range from 0- 30, and higher scores indicating more severe symptoms. | Data missing for some visits. | Posted | Mean | Standard Error | score on a scale | Change over baseline and weeks 1, 2, 3, 4, 5. |
|
|
|
|
| Secondary | Affective Reactivity Index (ARI) - Child | A child completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity. | Data missing for some visits | Posted | Mean | Standard Error | score on a scale | Change over baseline and weeks 4 and 5. |
|
|
|
|
| Secondary | Affective Reactivity Index (ARI) - Parent Report | A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity. | Data missing for some visits. | Posted | Mean | Standard Error | score on a scale | Change over baseline and weeks 4 and 5. |
|
|
|
|
| Secondary | Multidimensional Anxiety Scale for Children (MASC) - Child Report | A child completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity. | Data missing from some visits. | Posted | Mean | Standard Error | score on a scale | Change over baseline and weeks 4 and 5. |
|
|
|
|
| Secondary | Multidimensional Anxiety Scale for Children (MASC) - Parent Report | A parent completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity. | Data missing for some visits. | Posted | Mean | Standard Error | score on a scale | Change over baseline and weeks 4 and 5. |
|
|
|
|
| Secondary | Height | A dimensional measure assessed in centimeters (cm). | Data missing for some visits. | Posted | Least Squares Mean | Standard Error | cm. | Change over baseline and weeks 1, 4, and 5. |
|
|
|
|
| Secondary | Weight | A dimensional measure assessed in kilograms (kg). | Data missing for some visits. | Posted | Least Squares Mean | Standard Error | kg. | Change over baseline and weeks 1, 4, and 5. |
|
|
|
|
| Secondary | Systolic Blood Pressure | A dimensional measure expressed in mm mercury (Hg). | Data missing from some visits. | Posted | Least Squares Mean | Standard Error | mm Hg. | Change over baseline and weeks 1, 4, and 5. |
|
|
|
|
| Secondary | Diastolic Blood Pressure | A dimensional measure assessed in mm mercury (Hg). | Data missing for some visits. | Posted | Least Squares Mean | Standard Error | mm Hg. | Change over baseline and weeks 1, 4, and 5. |
|
|
|
|
| Secondary | Pulse | Heart rate in beats per minute (bpm). | Data missing for some visits. | Posted | Least Squares Mean | Standard Error | bpm. | Change over baseline and weeks weeks 1, 4, and 5. |
|
|
|
|
| Secondary | Children's Depression Inventory (CDI) | A child completed self-report dimensional measure of depressive symptoms, with range of scores from 0 to 54. Higher scores reflect increasing depression. Cutoff scores < 17 to 20 are generally considered to be in the normative range. A score of 36 or higher reflects a relatively severe depression. | Data missing for some visits. | Posted | Least Squares Mean | Standard Error | score on a scale | Change over baseline and weeks 4 and 5. |
|
|
|
|
| Secondary | Conners Global Index - Teacher | Teacher completed dimensional measure of ADHD symptoms, with scores ranging from 0-30, and higher scores indicating more severe symptoms. | Results may not be valid due to problems with data collection leading to substantial missing data. | Posted | Least Squares Mean | Standard Error | score on a scale | Change over baseline and weeks 1, 2, 3, 4, 5. |
|
|
|
|
| Other Pre-specified | Affective Posner Task | A laboratory measure of frustration tolerance. | Not Posted | Baseline, and Weeks 1 and 4 | Participants |
| Other Pre-specified | Attention Network Task (ANT) Response Inhibition | A computer-administered laboratory measure of executive function. | Not Posted | Baseline, Weeks 1 and 4 | Participants |
| Other Pre-specified | Spatial Working Memory (SWM) | A computer-administered laboratory measure of executive function. | Not Posted | Baseline, Weeks 1 and 4 | Participants |
| Other Pre-specified | Electroencephalography (EEG) | A laboratory measure of cortical activity. | Not Posted | Baseline and Week 4 | Participants |
| Other Pre-specified | Behavior Rating Inventory of Executive Functioning (BRIEF) | A parent completed rating of child executive function. Comprises 5 sub scales that measure various measures of behavior and cognition. Raw scores on each measure are converted to T scores ranging from 28 to 103, with higher scores indicating greater difficulties. | Not Posted | Baseline, end of Weeks 4 and 5. | Participants |
| Other Pre-specified | Children's Sleep Habits Questionnaire (CSHQ) | A parent completed 33-item scale to assess sleep related problems. Total scores range from 33 to 99 divided among 8 sub scales , with higher scores indicating more severe difficulties. | Not Posted | Weekly for double-blind trial. | Participants |
| 0 |
| 32 |
| 0 |
| 32 |
| 23 |
| 32 |
| EG001 | Sham TNS | Sham TNS Sham TNS: Participants randomized to sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep. | 0 | 30 | 0 | 30 | 22 | 30 |
| Nightmares | Psychiatric disorders | Systematic Assessment |
|
| Drowsy | Nervous system disorders | Systematic Assessment |
|
| Hyperactive | Psychiatric disorders | Systematic Assessment |
|
| Feels strange | Psychiatric disorders | Systematic Assessment |
|
| Tingling | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Stuffy nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Muscle cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Slurred speech | Nervous system disorders | Systematic Assessment |
|
| Rapid heartbeat | Cardiac disorders | Systematic Assessment |
|
| Trouble catching breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Stomachache | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Frequent urination | Renal and urinary disorders | Systematic Assessment |
|
| Frequent sweating | Nervous system disorders | Systematic Assessment |
|
| Decreased appetite | General disorders | Systematic Assessment |
|
| Increased appetite | General disorders | Systematic Assessment |
|
| Difficulty finding words | Nervous system disorders | Systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Apathy | Psychiatric disorders | Systematic Assessment |
|
| Clenching teeth | Psychiatric disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Wish to be dead. | Psychiatric disorders | Systematic Assessment | Based on Columbia-Suicide Severity Rating Scale (C-SSRS) |
|
| Non-specific active suicidal thoughts | Psychiatric disorders | Systematic Assessment | Based on Columbia-Suicide Severity Rating Scale (C-SSRS) |
|
| Active suicidal ideation without intent | Psychiatric disorders | Systematic Assessment |
|
| Active suicidal ideation with some intent | Psychiatric disorders | Systematic Assessment | Based on Columbia-Suicide Severity Rating Scale (C-SSRS) |
|
| Active suicidal ideation with active plan and intent | Psychiatric disorders | Systematic Assessment | Based on Columbia-Suicide Severity Rating Scale (C-SSRS) |
|
Not provided
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| Not Improved |
|
| Week 2 |
|
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| Week 3 |
|
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| Week 4 |
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| Week 5 |
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|
Phase 1a: Assessed effects of group and time on categorical measure CGI-I from Baseline through Visit 4. |
| Chi-squared |
Time: F = 1.69, df = 3/168. |
| .17 |
p < .05 for statistical significance. |
| Superiority |
| Phase 1b: Assessed effects of group on categorical measure CGI-I from at Visit 5 compared to baseline. | Chi-squared | Group: Chi-square = .53, df = 1. | .46 | Superiority |
| Week 1 |
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| Week 2 |
|
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| Week 3 |
|
|
| Week 4 |
|
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| Week 5 |
|
|
| Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week. | Mixed Models Analysis | Time: F=13.03; df = 1/209. | .0004 | Superiority |
| Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week. | Mixed Models Analysis | Group * time: F = .83; df = 1/209. | .37 | Superiority |
| Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week. | Mixed Models Analysis | .007 | Time2: F = 7.45, df = 1/209. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group: F = .19, df = 1/59. | .67 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Time: F = .17, df = 1/50. | .68 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group * time: F = 2.05, df = 1/50. | .16 | p < .05 for statistical significance. | Superiority |
| Week 4 |
|
|
| Week 5 |
|
|
Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects. |
| Mixed Models Analysis |
Time: F = 2.12, df = .15 |
| .15 |
p < .05 for statistical significance. |
| Superiority |
| Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects. | Mixed Models Analysis | Group * time: F = .21, df = 1/56. | .64 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group: F = .20, df = 1/59. | .66 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Time: F = .50, df = 1/47. | .48 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group * time: F = .06, df = 1/47. | .81 | p < .05 for statistical significance. | Superiority |
| Week 4 |
|
|
| Week 5 |
|
|
Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects. |
| Mixed Models Analysis |
Time: F = 2.28, df = 1/55. |
| .14 |
p < .05 for statistical significance. |
| Superiority |
| Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects. | Mixed Models Analysis | Group * time: F = .06, df = .81. | .80 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group: F = .01, df = 1/58. | .93 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Time: F = 2.22, df = 1/35. | .15 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group * time: F = 1.23, df = 1/35. | .28 | p < .05 for statistical significance. | Superiority |
| Week 4 |
|
|
| Week 5 |
|
|
Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects. |
| Mixed Models Analysis |
Time: F = 2.62, df = 1/46. |
| .11 |
p < .05 for statistical significance. |
| Superiority |
| Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects. | Mixed Models Analysis | Group * time: F = .71; df = .40. | .40 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group: F = .48. df = 1/55. | .49 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Time: F = 1.87, df = 1/55. | .18 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group * time: F = .13, df = 1/38. | .72 | p < .05 for statistical significance. | Superiority |
| Week 4 |
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| Week 5 |
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Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.
| Mixed Models Analysis |
Time: F = 3.58, df = 1/53. |
| .06 |
| Superiority |
| Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects. | Mixed Models Analysis | Group * time: F = 2.90, df 1/53. | .09 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group: F = 3.36, df = 1/58. | .06 | p < .05 for statistical significance | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Time: F = 4.20, df = 1/31. | .05 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group * time: F = .66, df = 1/31. | .42 | p < .05 for statistical significance. | Superiority |
| Week 1 |
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| Week 4 |
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| Week 5 |
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Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects. |
| Mixed Models Analysis |
Time: F = 5.83, df = 1/129. |
| .02 |
p < .05 for statistical significance. |
| Superiority |
| Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects. | Mixed Models Analysis | Group * time: F = 1.03, df = 1/129. | .31 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group: F = .16, df = 1/59. | .69 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Time: F = .98, df = 1/54. | .33 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group * time: F = .88, df = 1/54. | .35 | p < .05 for statistical significance. | Superiority |
| Week 1 |
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| Week 4 |
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| Week 5 |
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Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects. |
| Mixed Models Analysis |
Time: F = 5.18, df = 1/128. |
| .02 |
p < .05 for statistical significance. |
| Superiority |
| Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects. | Mixed Models Analysis | Group * time: F = 6.89, df = 1/128. | .01 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group: F= 2.16, df = 1/59. | .15 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Time: F = 4.15, df = 1/55. | .05 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group * time: F = .07, df = 1/55. | .79 | p < .05 for statistical significance. | Superiority |
| Week 1 |
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| Week 4 |
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| Week 5 |
|
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Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects. |
| Mixed Models Analysis |
Time: F = .09, df = 1/128. |
| .76 |
p < .05 for statistical significance. |
| Superiority |
| Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects. | Mixed Models Analysis | Group * time: F = .75, df =1/128. | .39 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group: F = 3.06, df = 1/59. | .09 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Time: F = .07, df = 1/55. | .79 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group * time: F = 1.55, df = 1/55. | .22 | p < .05 for statistical significance. | Superiority |
| Week 1 |
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| Week 4 |
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| Week 5 |
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Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects. |
| Mixed Models Analysis |
Time: F = 1.49, df = 1/128. |
| .19 |
p < .05 for statistical significance. |
| Superiority |
| Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects. | Mixed Models Analysis | Group * time: F = 1.49, df = 1/128. | .22 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group: F = 3.95, df = 1/59. | .05 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Time: F = 0.00, df = 1/55. | .96 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group * time: F = .01, df = 1/55. | .92 | p < .05 for statistical significance. | Superiority |
| Week 1 |
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| Week 4 |
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| Week 5 |
|
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Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects. |
| Mixed Models Analysis |
Time: F = 1.10, df = 1/128. |
| .30 |
p < .05 for statistical significance. |
| Superiority |
| Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects. | Mixed Models Analysis | Group * time: F = 4.61, df = 1/128. | .03 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group: F = 2.24, df = 1/59. | .14 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Time: F = .05, df = 1/55. | .82 | p < .05 for statistical significance. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group * time: F = 3.35, df = 1/55. | .07 | p < .05 for statistical significance. | Superiority |
| Week 4 |
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| Week 5 |
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Phase 1a: Outcomes were fitted via a mixed model with group, time, and group-by-time interactions to test for treatment effects.
| Mixed Models Analysis |
Time: F = .09, df = 1/52 |
| .34 |
| Superiority |
| Phase 1 a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interaction to test for treatment effects. | Mixed Models Analysis | Group * time: F = .06, df = 1/52 | .81 | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group: F = .05, df = 1/59 | .83 | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Time: F = 4.52, df = 1/43 | .04 | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group * time: F = .12, df = 1/43 | .73 | Superiority |
| Week 1 |
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| Week 2 |
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| Week 3 |
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| Week 4 |
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| Week 5 |
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| Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week. | Mixed Models Analysis | Time: F = .74, df = 1/58. | .39 | Superiority |
| Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week. | Mixed Models Analysis | Time2: F = 1.88, df = 1/58. | .18 | Superiority |
| Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week. | Mixed Models Analysis | Group * time: F = 1.56; df = 1/58. | .22 | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group: F = 1.72, df = 1/12. | .21 | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Time: F = 0.00, df = 1/0. | 1 | Test not valid due to insufficient data. | Superiority |
| Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5. | Mixed Models Analysis | Group * time: F = .87, df = 1/0. | 1 | Test not valid due to insufficient data. | Superiority |