ClinicalTrials.gg
RecruitingNCT06248229Updated Nov 21, 2024

A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder (ADHD).

A Phase 4 interventional study of Dyanavel XR and Placebo in Fatigue, Attention Deficit Hyperactivity Disorder and Attention Deficit Disorder, sponsored by Rochester Center for Behavioral Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-21.

Sponsored by Rochester Center for Behavioral Medicine · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 2 months later.

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Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 704 studies in Fatigue with a site in United States — 92 open to participants now, 114 under way, 10 of them phase 3. Fatigue · United States.

Planned enrollment
287th of 610
50 · median 47
Started
2024
with 31 others
Phase 4
26 of 704
2 open now
Primary completion
2026-09
later than 26 of 113 live
Registered
602nd of 704
by date

Among the 704 studies in Fatigue with a site in United States, this one is the 287th largest by planned enrollment of the 610 interventional ones that give a count, is one of 32 that started in 2024, is one of 26 in phase 4, reaches primary completion later than 26 of the 113 other live ones, and was the 602nd registered.

Fatigue

2,231 studies on the registry are indexed under Fatigue; 427 are open to participants now.

Browse Fatigue studies →

Open to participants now

92 of the 704 studies in Fatigue with a site in United States are open now. Recruiting first, the newest first:

87 more — sign in →

All 92 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 239 Fatigue studies recruiting now, 111 (46%) set no upper age limit and 98 (41%) stop at 75 or younger; 23 take children under 18; 73 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 704 studies in Fatigue with a site in United States, or all of them as a file.
02

Study summary

The goal of this clinical trial is to study the impact of Dyanavel on co-occuring fatigue in adults with Attention Deficit/Hyperactivity Disorder. The main question it aims to answer is whether Dyanavel XR leads to a statistically significant reduction in fatigue compared to placebo, as measured by the Fatigue Symptom Inventory.

Read the detailed description

10-week single center, randomized, double-blind, placebo-controlled, flexible titration trial evaluating the efficacy of Dyanavel (Dyanavel XR) XR in the treatment of fatigue symptoms in adult subjects with a diagnosis of ADHD. Subjects will be randomly assigned (1:1) to a Dyanavel (Dyanavel XR) XR (flexible titration dosing) group (n = 22 to 25) or placebo group (n = 22 to 25). The study will utilize an intent to treat model and impute data, if statistically feasible, from dropouts utilizing a MNAR (missing not at random) approach.

03

Conditions studied

  • Fatigue
  • Attention Deficit Hyperactivity Disorder
  • Attention Deficit Disorder
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • At screening, all subjects must have a Fatigue Symptom Inventory average score on both of the interference and severity scales greater than 3.
  • At screening, all subjects must score in the range on the ADHD-RS-IV, meaning a score greater than 36.
  • At screening, all subjects must meet criteria for an ADHD diagnosis as determined by the SCID-5 ADHD module.
  • All subjects must be 18-65 years of age at the time of consent.
  • All sexually active males or females of child baring potential must agree to practice two different methods of or remain abstinent during the course of the trial. Methods of birth control or contraception will be logged. Male and female contraception will be continued throughout the study and for 30 days after study discontinuation. Women of must test negative for pregnancy at the Screening Visit.
  • All subjects must live within the state of Michigan during the duration of the trial or be able to commute to the study site from a neighboring state with no more than a 50 mile one-way driving distance.
  • All subjects must be able to swallow intact tablets.
  • Subjects, in the opinion of the investigator, must be able to understand and comply with protocol requirements- including assessments, prescribed dosage regimens, and discontinuation of concomitant medications.
  • All subjects must have a minimum level of intellectual functioning without evidence of significant general intellectual deficit, as determined by the primary investigator. Specific learning disorders will not be considered general intellectual deficits.
  • All subjects must be able to provide written, personally signed and dated to participate in the study in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations before completing any study related procedures.
  • All subjects must be fluent in English and have a degree of understanding sufficient to communicate suitably with the primary investigator and the study coordinator.
  • Subjects must have a negative drug screen for methamphetamine, cocaine and other illicit drugs (illegal for recreational use in the State of Michigan) excluding cannabis due to legality of cannabis in Michigan. Subjects with a positive drug screen for confirmed prescription or over the counter use of medications will require the necessary washout per PI instruction. Subjects who test positive for any prohibited medications per PI may be permitted with PI approval. Re-tests will not be allowed for a positive screen of an illicit drug.
  • All subjects must score at or above a 4 on the CGI-S at screening

Exclusion criteria

Exclusion Criteria:

  • Subjects must not be an immediate family of the Investigator or others directly affiliated with the study.
  • Subjects must not have received treatment with a drug that has not received regulatory approval or participated in a clinical trial within 30 days prior to screening.
  • Subjects must not have medical complications arising from being severely underweight or overweight.
  • Subjects must not have a current comorbid psychiatric disorder that is uncontrolled and associated with significant symptoms or that requires a prohibited medication or behavioral modification program. Comorbid psychiatric diagnoses will be assessed during a psychiatric intake and scoring of the SCID and MINI. The Investigator will review on a case by case basis.
  • Subjects must not currently be considered a suicide risk (as determined by the primary investigator and assessed by the C-SSRS). They must not have made a suicide attempt within the past two years. They cannot have current suicidal ideation with intent and plan to act, or current suicidal behavior.
  • Subjects must not have a history of substance abuse or drug dependence according to criteria currently or within one year prior to study participation, excluding nicotine and caffeine. This is determined through clinical history and symptom checklist to be obtained at visit 1.
  • Subjects must not test positive for an illicit substance at the time of screening.
  • Subjects must not have a serious chronic or acute unstable medical condition or illness, including cardiovascular, renal, hepatic, respiratory, or hematologic illness, narrow angle glaucoma, or other unstable medical or psychiatric conditions that in the opinion of the Investigator would compromise participation or would likely lead to hospitalization during the duration of the study. Subjects with a history of intellectual impairment or a severe learning disability are also excluded.
  • Subjects must not have a history of seizure disorder (other than infantile febrile seizures), any tic disorder, current diagnosis and/or family history of Tourette's disorder.
  • Subjects must not have a history of organic heart disease including coronary artery disease, past myocardial infarction, angina, arrhythmias, congestive heart failure, valvular heart disease and congenital heart disease.
  • Subjects must not be likely (as assessed by the primary investigator) to add psychotropic medications, apart from their current regimen or the drug under study, to their treatment regimen during the course of the study.
  • Subjects must not have been previously enrolled in this study.
  • Subjects must not anticipate relocation outside the geographic range of the investigative site during participation in the study. Subjects must not have extended travel plans inconsistent with the recommended visit intervals.
  • Subjects must not be taking any excluded medications that cannot be discontinued prior to beginning treatment with study medication. Subjects' medical history will be reviewed by the PI and current prescription regimen will be reviewed for wakefulness-promoting drugs including CNS stimulants, histaminergic, noradrenergic and dopaminergic medications, as well as CYP2D6 inhibitors. The primary investigator will determine on a case by case basis if concomitant use of the patient's current prescriptions would affect response to Dyanavel XR. Stimulant medications must be washed out prior to baseline (methylphenidate or amphetamine based).
  • Subjects must not have a known , allergy intolerance or documented history of non-responsivity to amphetamine-based medications.
  • Subjects who, in the opinion of the Investigator, are unsuitable in any other way to participate in the study.
  • Subjects who have taken an MAOI within 14 days of the beginning of the study.
  • Subjects currently taking a medication regimen that would otherwise likely interfere with the efficacy of Dyanavel XR or the integrity of study results as determined on a case by case basis by the primary investigator.
  • Subjects who have recently (within the previous 3 months) been on CNS stimulant medications
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Dyanavel XR (Active Agent)

    Dyanavel 5, 10, 15 or 20 mg once daily in the morning

    Drug: Dyanavel XR

  • Placebo comparator
    Placebo

    Matching placebo 5, 10, 15 or 20 mg once daily in the morning

    Drug: Placebo

Interventions

  • Dosing will begin the morning following Visit 2. Subjects in the active group will begin the study on 5 mg of Dyanavel XR. Subjects will be advised to take one capsule each morning upon awakening, dosed consistently with respect to time. Subjects will be advised that tablets should be swallowed whole, not crushed, chewed, or cut. Subjects can take Dyanavel XR with or without food. Subjects will return to the study site on a weekly (and later, bi-weekly) basis for evaluation of symptoms and possible side effects. Subjects will be titrated to their optimal dose based on the dose titration schedule displayed in Section 5.1. The PI will be available to consult with patients as needed between Week 0 and Week 4 to adjust dosage per the PI's clinical judgment.

  • DrugPlacebo

    Dosing will begin the morning following Visit 2. Subjects in the placebo group will begin the study on 5 mg of placebo. Subjects will be advised to take one tablet each morning upon awakening, dosed consistently with respect to time. Subjects will be advised that tablets should be swallowed whole, not crushed, chewed, or cut. Subjects can take Dyanavel XR with or without food. Subjects will return to the study site on a weekly (and later, bi-weekly) basis for evaluation of symptoms and possible side effects. Subjects will be titrated to their optimal dose based on the dose titration schedule displayed in Section 5.1. The PI will be available to consult with patients as needed between Week 0 and Week 4 to adjust dosage per the PI's clinical judgment.

06

What researchers measure

Primary outcomes

  1. Fatigue Symptom Inventory (FSI)

    Rating scale completed by study coordinator or PI. Score would be 0-10 with 10 being a worse outcome.

    Time frame: Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8

Secondary outcomes

  1. Behavior Rating Inventory of Executive Functioning- Adult (BRIEF-A)

    Rating scale to assess subject's cognitive functioning. T scores are used to interpret the individual's level of executive functioning, and are derived from their raw scores. T-scores of 65 or over are considered clinically significant.

    Time frame: Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8

  2. ADHD Rating Scale (ADHD-RS)

    Rating scale to evaluate symptoms of adult ADHD. Scores range from 0-54, with higher scores indicates a worse outcome.

    Time frame: Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8

  3. ADHD Quality of Life Scale (ADHDQOL)

    Rating scale to assess quality of life, with possible scores ranging from 0-100. Higher scores are indicative of a better outcome.

    Time frame: Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8

  4. Clinical Global Impression Scales (CGI)

    Clinician's subjective rating of subject's severity on a 7-point likert scale from 0-7, with higher scores indicative of a worse outcome.

    Time frame: Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8

  5. Epworth Sleepiness Scale (ESS)

    Rating scale to assess level of daytime sleepiness. Scoers range from 0-24 with higher scores indicative of a worse outcome.

    Time frame: Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8

  6. Insomnia Severity Index (ISI)

    Rating scale to assess level of insomnia. Scores range from 0-28 with higher scores indicative of a worse outcome.

    Time frame: Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8

  7. Fibromyalgia Impact Questionnaire

    Rating scale to assess subject's symptoms of fibromyalgia. Scores can range from 0-80, with higher scores indicative of a worse outcome.

    Time frame: Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2024 (actual). Primary completion is estimated for Sep 2026, 24 months after the start.

Of 15 phase 4 interventional studies under Fatigue, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 55. This study's planned 24 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 31, 2024
First posted
Feb 8, 2024
StartActual
Sep 1, 2024
Primary completionEst.
Sep 1, 2026
CompletionEst.
Dec 1, 2026
Last update
Nov 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06248229
Lead sponsor
Rochester Center for Behavioral Medicine
Responsible party
Sponsor
First posted
Feb 8, 2024
Start date
Sep 1, 2024
Primary completion
Sep 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Nov 21, 2024

Study contacts

Jaime Saal, MA
Contact
jsaal@rcbm.net
2486088800 ext. 231
Joel Young, MD
principal investigator · Medical Director

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Amphetamine

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