BridgeMD
New treatment option for Fatigue
Official title A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder (ADHD).
ClinicalTrials.gov ID: NCT06248229
What this study is testing
What is Dyanavel XR?
Dyanavel XR is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for fatigue.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- At screening, all people must have a Fatigue Symptom Inventory average score on both of the interference and severity scales greater than 3.
- At screening, all people must score in the clinically significant range on the ADHD-RS-IV, meaning a score greater than 36.
- At screening, all people must meet criteria for an ADHD diagnosis as determined by the SCID-5 ADHD module.
- All people 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 birth control or remain abstinent...
You likely can't join if
- people must not be an immediate family of the Investigator or others directly affiliated with the study.
- people must not have received treatment with a drug that has not received regulatory approval or participated in a clinical trial within 30 days...
- people must not have medical complications arising from being severely underweight or overweight.
- people must not have a current comorbid psychiatric disorder that is uncontrolled and associated with significant symptoms or that requires a...
- people must not currently be considered a suicide risk (as determined by the primary investigator and assessed by the C-SSRS). They must not have...
- people must not have a history of substance abuse or drug dependence according to DSM-5 criteria currently or within one year prior to study...
See the full eligibility criteria
Who can join
- At screening, all people must have a Fatigue Symptom Inventory average score on both of the interference and severity scales greater than 3.
- At screening, all people must score in the clinically significant range on the ADHD-RS-IV, meaning a score greater than 36.
- At screening, all people must meet criteria for an ADHD diagnosis as determined by the SCID-5 ADHD module.
- All people 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 birth control or remain abstinent during the course of the trial. Methods of birth control or contraception...
- All people 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 people must be able to swallow intact tablets.
- people, 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 people 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...
- All people must be able to provide written, personally signed and dated informed consent to participate in the study in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP)...
- All people must be fluent in English and have a degree of understanding sufficient to communicate suitably with the primary investigator and the study coordinator.
- people 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. people...
- All people must score at or above a 4 on the CGI-S at screening
What rules you out
- people must not be an immediate family of the Investigator or others directly affiliated with the study.
- people 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.
- people must not have medical complications arising from being severely underweight or overweight.
- people 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...
- people 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...
- people must not have a history of substance abuse or drug dependence according to DSM-5 criteria currently or within one year prior to study participation, excluding nicotine and caffeine. This is determined through...
- people must not test positive for an illicit substance at the time of screening.
- people 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...
- people 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.
- people 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.
- people 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.
- people must not have been previously enrolled in this study.
- people must not anticipate relocation outside the geographic range of the investigative site during participation in the study. people must not have extended travel plans inconsistent with the recommended visit...
- people must not be taking any excluded medications that cannot be discontinued prior to beginning treatment with study medication. people' medical history will be reviewed by the PI and current prescription regimen will...
- people must not have a known hypersensitivity, allergy intolerance or documented history of non-responsivity to amphetamine-based medications.
- people who, in the opinion of the Investigator, are unsuitable in any other way to participate in the study.
- people who have taken an MAOI within 14 days of the beginning of the study.
- people currently taking a medication regimen that would otherwise likely interfere with the how well it works of Dyanavel XR or the integrity of study results as determined on a case by case basis by the primary...
- people who have recently (within the previous 3 months) been on CNS stimulant medications
The study team makes the final eligibility decision.
Where it's taking place
- Rochester Hills, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester Hills, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.