Dyanavel XR for ADHD and Fatigue
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that some medications, especially stimulant medications like methylphenidate or amphetamine-based drugs, be stopped before starting the study. The primary investigator will review your current medications to decide if they might interfere with the study drug.
What data supports the effectiveness of the drug Dyanavel XR for ADHD and fatigue?
Is Dyanavel XR safe for humans?
Dyanavel XR, an extended-release amphetamine, is generally well tolerated in clinical trials for ADHD, with safety shown in both children and adults. However, its safety in people with heart conditions hasn't been fully evaluated, though a study showed it could be safely used in adults with high blood pressure.36789
How is the drug Dyanavel XR unique for treating ADHD and fatigue?
Dyanavel XR is unique because it is an extended-release oral suspension of amphetamine, designed for those who have difficulty swallowing pills, allowing for flexible dosing based on daily needs. This formulation can be titrated (adjusted) with a single prescription, offering convenience and potentially better adherence for patients.1371011
Research Team
Joel Young, MD
Principal Investigator
Medical Director
Eligibility Criteria
Adults aged 18-65 with ADHD and significant fatigue living in or near Michigan, who can swallow tablets and follow the study plan. They must score high on specific ADHD and fatigue scales, have no major intellectual deficits, agree to use two birth control methods if applicable, and sign informed consent.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Dyanavel XR or placebo with flexible titration dosing for 10 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dyanavel XR
Dyanavel XR is already approved in United States for the following indications:
- Attention Deficit Hyperactivity Disorder (ADHD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rochester Center for Behavioral Medicine
Lead Sponsor