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A double-blind, placebo controlled study of solriamfetol for adults age 18 to 65 with diagnosis of Attention Deficit Hyperactivity Disorder.
Subjects will be between 18 and 65 years old, have at least 5 current symptoms of inattentive or impulsive-hyperactive traits, and childhood onset of ADHD symptoms, defined as two symptoms of inattentive or of impulsive/hyperactive traits by the age of 12. Subjects will also have a score of 20 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS).
The investigators will exclude individuals who are contraindicated by current FDA label recommendations, which elaborates appropriate use of solriamfetol for individuals with sleep apnea and narcolepsy.
This will be a a six week, double blind, dose-optimization study. After giving informed consent to participate, participants will undergo a comprehensive assessment including a psychiatric assessment reviewing eligibility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| solriamfetol | Experimental | Participant will receive daily doses of solriamfetol, at 75 mg at week one and 150 mg at week 2, and with intention that dosing remain stable for the last four weeks of study participation, such that investigators will ask a subject to go back down to 75 mg during any of the weeks following week 2 only if only if 150 mg is not tolerated. |
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| placebo | Placebo Comparator | Participant will receive daily doses of placebo, at 75 mg at week one and 150 mg at week 2, and with intention that dosing remain stable for the last four weeks of study participation, such that investigators will ask a subject to go back down to 75 mg during any of the weeks following week 2 only if only if 150 mg is not tolerated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solriamfetol 75 MG | Drug | Daily oral consumption |
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| Measure | Description | Time Frame |
|---|---|---|
| Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score | Difference between active and placebo for change in Adult ADHD Investigator Symptom Rating total score from baseline to week 6 visit. The minimum score on this scale is 0, the maximum score for the scale is 54 points.Higher numbers indicate more ADHD symptoms, lower scores reflect lower ADHD symptoms. | six weeks |
| A Priori Definition of Clinical Improvement | 25% reduction in ADHD symptoms as measured by the Adult ADHD Investigator Symptom Rating Scale (AISRS), and a Clinical Global Impression Improvement score of 2 (much) or 1 (very much) improved. The minimum score on the AISRS scale is 0, the maximum score for the scale is 54 points.Higher numbers indicate more ADHD symptoms, lower scores reflect lower ADHD symptoms. The Clinical Global Impression (CGI) Improvement scores range from 0 to 7, with 0=not assessed,1=very much improved), 2=much improved, through to 7=very much worse. Lower scores therefore mean better outcomes. | six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Global Executive Composite Index | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. Ther are 9 subscales that are indexed under two categories, Behavioral Regulation (BRI) and Metacognition (MI), and these indexes form the overall summary score, the Global Executive Composite (GEC). Raw scores for each scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. |
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Inclusion Criteria:
Exclusion Criteria:
14, Reasonable suspicion of inability, in the judgement of the investigator, to appropriately monitor experiences during the study and take steps to report these experiences or respond in a manner preserving personal health and safety.
15. If clinically appropriate, any subjects taking medication exclusionary to the study (including agents used for management of ADHD) must be tapered off this medication prior to baseline visit for the length of 5 half-lives of the medication, corresponding to 95% of the agent leaving the participant's system), plus several days or otherwise sufficient period of time to allow assessment of eligibility for participation off medication.
16. Any condition, including a moderate to severe untreated sleep disorder or other mental health disorder, that renders inability, in the investigator's judgement, to determine whether ADHD symptoms are primarily due to ADHD.
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| Name | Affiliation | Role |
|---|---|---|
| Craig Surman, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37819836 | Derived | Surman CBH, Walsh DM, Horick N, DiSalvo M, Vater CH, Kaufman D. Solriamfetol for Attention-Deficit/Hyperactivity Disorder in Adults: A Double-Blind Placebo-Controlled Pilot Study. J Clin Psychiatry. 2023 Oct 9;84(6):23m14934. doi: 10.4088/JCP.23m14934. |
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66 participants signed consent to participate in the study, per definition of enrollment. 6 of these participants ended up being excluded, and were never exposed (3 lost to follow up, 2 withdrew, 1 found to be ineligible after enrollment). 60 participants total were exposed to solriamfetol or placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Solriamfetol | Participant will receive daily doses of solriamfetol, at 75 mg at week one and 150 mg at week 2, and with intention that dosing remain stable for the last four weeks of study participation, such that investigators will ask a subject to go back down to 75 mg during any of the weeks following week 2 only if only if 150 mg is not tolerated. Solriamfetol 75 MG: Daily oral consumption Solriamfetol 150 MG: Daily oral consumption |
| FG001 | Placebo | Participant will receive daily doses of placebo, at 75 mg at week one and 150 mg at week 2, and with intention that dosing remain stable for the last four weeks of study participation, such that investigators will ask a subject to go back down to 75 mg during any of the weeks following week 2 only if only if 150 mg is not tolerated. Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Solriamfetol | Participant will receive daily doses of solriamfetol, at 75 mg at week one and 150 mg at week 2, and with intention that dosing remain stable for the last four weeks of study participation, such that investigators will ask a subject to go back down to 75 mg during any of the weeks following week 2 only if only if 150 mg is not tolerated. Solriamfetol 75 MG: Daily oral consumption Solriamfetol 150 MG: Daily oral consumption |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score | Difference between active and placebo for change in Adult ADHD Investigator Symptom Rating total score from baseline to week 6 visit. The minimum score on this scale is 0, the maximum score for the scale is 54 points.Higher numbers indicate more ADHD symptoms, lower scores reflect lower ADHD symptoms. | Posted | Mean | 95% Confidence Interval | score on a scale | six weeks |
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Baseline to endpoint (6 weeks)
Adverse events were reported at weekly study visits or spontaneously by subjects
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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 | Solriamfetol | Participant will receive daily doses of solriamfetol, at 75 mg at week one and 150 mg at week 2, and with intention that dosing remain stable for the last four weeks of study participation, such that investigators will ask a subject to go back down to 75 mg during any of the weeks following week 2 only if only if 150 mg is not tolerated. Solriamfetol 75 MG: Daily oral consumption Solriamfetol 150 MG: Daily oral consumption |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold/Infection/Allergy | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Craig Surman | Massachusetts General Hospital | 6176808489 | csurman@partners.org |
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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 | Oct 22, 2022 | Dec 6, 2023 | Prot_SAP_000.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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| ID | Term |
|---|---|
| C000623308 | solriamfetol |
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| Solriamfetol 150 MG | Drug | Daily oral consumption |
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| Placebo | Other | Placebo |
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| 6 weeks |
| Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Behavioral Regulation Index | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores. The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales that are indexed under two categories, one of which is Behavioral Regulation (BRI). The raw score of the BRI is converted into a T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | 6 weeks |
| Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Metacognition Index | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales that are indexed under two categories, one of which is Metacognition Index (MI). The raw score of the MI is converted into a T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | 6 weeks |
| Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Inhibit Subscale | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Inhibit subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | 6 weeks |
| Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Shift Subscale | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. Ther are 9 subscales that are indexed under two categories, one of which is the Shift subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | 6 weeks |
| Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Emotional Control Subscale | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Emotional Control subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | 6 weeks |
| Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Self-Monitor Subscale | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Self-Monitor subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | 6 weeks |
| Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Initiate Subscale | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Initiate subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | 6 weeks |
| Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Working Memory Subscale | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores) The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Working Memory subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | 6 weeks |
| Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Plan/Organize Subscale | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Plan/Organize subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | 6 weeks |
| Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Task Monitor Subscale | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Task Monitor subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | 6 weeks |
| Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Organization of Materials Subscale | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Organization of Materials subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | 6 weeks |
| BG001 | Placebo | Participant will receive daily doses of placebo, at 75 mg at week one and 150 mg at week 2, and with intention that dosing remain stable for the last four weeks of study participation, such that investigators will ask a subject to go back down to 75 mg during any of the weeks following week 2 only if only if 150 mg is not tolerated. Placebo: Placebo |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Highest Education | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Socioeconomic Status | Yearly Household Income | Mean | Standard Deviation | Dollars |
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| Clinical Global Impressions Severity (Baseline) | Clinical Global Impressions (CGI) scale for ADHD. The CGI is a measure of illness severity, improvement, and efficacy of treatment. The CGI asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" A higher number signifies a higher rating of mental illness. | Count of Participants | Participants |
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| Global Assessment of Functioning Scale Score (Baseline) | The Global Assessment of Functioning (GAF) scale is a clinician rated scale that assesses global functioning using a scale from 1 (worst) to 100 (best). | Mean | Full Range | total score on a scale |
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| OG001 | Placebo | Participant will receive daily doses of placebo, at 75 mg at week one and 150 mg at week 2, and with intention that dosing remain stable for the last four weeks of study participation, such that investigators will ask a subject to go back down to 75 mg during any of the weeks following week 2 only if only if 150 mg is not tolerated. Placebo: Placebo |
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| Primary | A Priori Definition of Clinical Improvement | 25% reduction in ADHD symptoms as measured by the Adult ADHD Investigator Symptom Rating Scale (AISRS), and a Clinical Global Impression Improvement score of 2 (much) or 1 (very much) improved. The minimum score on the AISRS scale is 0, the maximum score for the scale is 54 points.Higher numbers indicate more ADHD symptoms, lower scores reflect lower ADHD symptoms. The Clinical Global Impression (CGI) Improvement scores range from 0 to 7, with 0=not assessed,1=very much improved), 2=much improved, through to 7=very much worse. Lower scores therefore mean better outcomes. | Posted | Count of Participants | Participants | six weeks |
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| Secondary | Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Global Executive Composite Index | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. Ther are 9 subscales that are indexed under two categories, Behavioral Regulation (BRI) and Metacognition (MI), and these indexes form the overall summary score, the Global Executive Composite (GEC). Raw scores for each scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Behavioral Regulation Index | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores. The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales that are indexed under two categories, one of which is Behavioral Regulation (BRI). The raw score of the BRI is converted into a T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Metacognition Index | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales that are indexed under two categories, one of which is Metacognition Index (MI). The raw score of the MI is converted into a T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Inhibit Subscale | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Inhibit subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Shift Subscale | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. Ther are 9 subscales that are indexed under two categories, one of which is the Shift subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Emotional Control Subscale | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Emotional Control subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Self-Monitor Subscale | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Self-Monitor subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Initiate Subscale | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Initiate subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Working Memory Subscale | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores) The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Working Memory subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Plan/Organize Subscale | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Plan/Organize subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Task Monitor Subscale | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Task Monitor subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Organization of Materials Subscale | We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Organization of Materials subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores reflect worse functioning, and lower scores reflect better functioning. | Posted | Count of Participants | Participants | 6 weeks |
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| 0 |
| 29 |
| 0 |
| 29 |
| 28 |
| 29 |
| EG001 | Placebo | Participant will receive daily doses of placebo, at 75 mg at week one and 150 mg at week 2, and with intention that dosing remain stable for the last four weeks of study participation, such that investigators will ask a subject to go back down to 75 mg during any of the weeks following week 2 only if only if 150 mg is not tolerated. Placebo: Placebo | 0 | 31 | 0 | 31 | 28 | 31 |
| Increased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Nausea/Vomiting/Diarrhea (Gastrointestinal) | Gastrointestinal disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Sedation | General disorders | Systematic Assessment |
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| Increased Energy | General disorders | Systematic Assessment |
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| Cardiovascular | Cardiac disorders | Systematic Assessment |
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| Tense/jittery | General disorders | Systematic Assessment |
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| Agitated/irritable | General disorders | Systematic Assessment |
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| Anxious/Worried | Psychiatric disorders | Systematic Assessment |
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| Mucosal Dryness | Gastrointestinal disorders | Systematic Assessment |
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| Dizzy/Lightheaded | General disorders | Systematic Assessment |
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| Neurological | Nervous system disorders | Systematic Assessment |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Genitourinary | Renal and urinary disorders | Systematic Assessment |
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| Dermtological | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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Not provided
Not provided