Attention Deficit Hyperactivity DisorderPhase 2/3NCT04839562
A Controlled Study of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD) in Adults
A Phase 2/3 study testing Solriamfetol 75 MG and Solriamfetol 150 MG in people with Attention Deficit Hyperactivity Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
A double-blind, placebo controlled study of solriamfetol for adults age 18 to 65 with diagnosis of Attention Deficit Hyperactivity Disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Solriamfetol 75 MG and Solriamfetol 150 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2021to 27 Jan 2023
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ages 18-65 years of age.
- 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.
- A score of 20 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS)
Who cannot join
- Individuals with known renal insufficiency or renal impairment.
- A history of intolerance to solriamfetol
- 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.
- 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.
- Any medical condition that the Principal Investigator (PI) believes will be exacerbated by study participation.
- A history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to screening.
Show all 16Show fewer
- A known history of narrow-angle glaucoma.
- Current (within 3 months) DSM-V criteria for abuse or dependence with any psychoactive substance other than nicotine.
- 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.
- 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.
- Current use of MAO Inhibitor or use within the past two weeks.
- Concomitant medications with high potential for dopaminergic or sympathomimetic effects.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Solriamfetol for ADHD in Adults: A Double-Blind Placebo Controlled Pilot Study
A double-blind, placebo controlled study of solriamfetol for adults age 18 to 65 with diagnosis of Attention Deficit Hyperactivity Disorder.
Read the detailed 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Solriamfetol 75 MG, Solriamfetol 150 MG, Placebo
- Keywords
- attention deficit hyperactivity disorder, clinical trial, solriamfetol
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solriamfetol 75 MGDrug
Also called Sunosi 75 mg
Daily oral consumption
Solriamfetol 150 MGDrug
Also called Sunosi 150 mg
Daily oral consumption
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Solriamfetol 75 MG; Drug: Solriamfetol 150 MG |
| 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: six weeks
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start6 Aug 2021
- Primary completion27 Jan 2023
- Study completion27 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig B. Surman, MD, Massachusetts General Hospital
- Investigators
- Craig Surman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839562
- Sponsor's protocol ID
- 2020P003608
- Status last verified
- Mar 2024
- First submitted
- 6 Apr 2021
- Last updated
- 4 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37819836
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solriamfetol for ADHD in Adults: A Double-Blind Placebo Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04839562
- Acronym / sponsor ID
- 2020P003608
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- attention deficit hyperactivity disorder, clinical trial, solriamfetol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Posted 4 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double-blind, placebo controlled study of solriamfetol for adults age 18 to 65 with diagnosis of Attention Deficit Hyperactivity Disorder.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| solriamfetol | Experimental | Drug: Solriamfetol 75 MG, Drug: Solriamfetol 150 MGParticipant 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. |
| placebo | Placebo comparator | Other: PlaceboParticipant 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ages 18-65 years of age.
- 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.
- A score of 20 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS)
Key exclusion criteria (16 listed)
- Individuals with known renal insufficiency or renal impairment.
- A history of intolerance to solriamfetol
- 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.
- 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.
- Any medical condition that the Principal Investigator (PI) believes will be exacerbated by study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solriamfetol 75 MGAlso: Sunosi 75 mgDaily oral consumption | Drug | solriamfetol |
| Solriamfetol 150 MGAlso: Sunosi 150 mgDaily oral consumption | Drug | solriamfetol |
| PlaceboPlacebo | Other | placebo |
Primary outcome
Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score
Time frame: six weeks
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.
A Priori Definition of Clinical Improvement
Time frame: six weeks
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.
12 secondary outcomes
Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Global Executive Composite Index
Time frame: 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
Time frame: 6 weeks
Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Metacognition Index
Time frame: 6 weeks
Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Inhibit Subscale
Time frame: 6 weeks
Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Shift Subscale
Time frame: 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
Time frame: 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
Time frame: 6 weeks
Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Initiate Subscale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37819836Surman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Surman, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Solriamfetol 75 MG and Solriamfetol 150 MG in people with Attention Deficit Hyperactivity Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score (time frame: six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04839562, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.