A Controlled Study of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD) in Adults

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Solriamfetol for ADHD in Adults: A Double-Blind Placebo Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04839562
• Other study ID #: 2020P003608
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 6, 2021
• Est. completion date: January 27, 2023

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A double-blind, placebo controlled study of solriamfetol for adults age 18 to 65 with diagnosis of Attention Deficit Hyperactivity Disorder.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 27, 2023
• Est. primary completion date: January 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Adults ages 18-65 years of age.

2. A diagnosis of childhood-onset ADHD, meeting the Diagnostic and Statistical Manual-5 (DSM-5) criteria for ADHD in adulthood, including at least 5 current symptoms of inattentive or impulsive-hyperactive traits, and childhood onset by age 12, defined as two symptoms of inattentive or of impulsive/hyperactive traits by the age of 12.

3. A score of 20 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS)

Exclusion Criteria:

1. Individuals with known renal insufficiency or renal impairment.

2. A history of intolerance to solriamfetol

3. Pregnant or nursing females, and individuals unwilling to use adequate contraceptive methods to avoid conception while they are receiving study agent and for 1 month after the last dose of study agent. For female subjects of childbearing potential adequate contraceptive methods will include: a medically acceptable form of birth control (such as male or female condoms with or without spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, hormonal contraceptives like birth control pills, or abstinence). For male subjects this will include use of male condom, being status post vasectomy at least 4 months prior to initiation of study drug exposure, or abstinence during the study.

4. A known unstable major medical illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including hypertension = 140/90 mmHg), endocrinologic (e.g. thyroid), neurologic (e.g. seizure), immunologic, hematologic, or psychiatric (including an active substance use disorder, psychosis, bipolar disorder, major depression) disorder.

5. Any medical condition that the Principal Investigator (PI) believes will be exacerbated by study participation.

6. A history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to screening.

7. A known history of narrow-angle glaucoma.

8. Current (within 3 months) DSM-V criteria for abuse or dependence with any psychoactive substance other than nicotine.

9. Multiple adverse drug reactions, defined as previous moderate to severe adverse experiences while on two or more chemically unrelated compounds, where these reactions were unpredictable from the known pharmacology of the drug.

10. Any other concomitant medication with primarily central nervous system activity that are catecholaminergic such as stimulants or atomoxetine, or have strong noradrenergic mechanisms of action such as duloxetine or venlafaxine or buproprion. Subjects may be included who are taking stable doses of agents with primary serotonergic (such as selective serotonin reuptake inhibitors or buspirone), gabaergic (such as gabapentin, pregabalin), or other anticonvulsants. We will also allow participation by individuals with rare (predicted to be less than twice a week) use of prn benzodiazepines or sedative-hypnotics.

11. Current use of MAO Inhibitor or use within the past two weeks.

12. Concomitant medications with high potential for dopaminergic or sympathomimetic effects.

13. Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Solriamfetol 75 MG
Daily oral consumption
• Solriamfetol 150 MG
Daily oral consumption

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	six weeks
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.	six weeks
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.	6 weeks
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.	6 weeks
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.	6 weeks
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.	6 weeks
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.	6 weeks
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.	6 weeks
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.	6 weeks
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.	6 weeks
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.	6 weeks
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.	6 weeks
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.	6 weeks
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.	6 weeks