RecruitingPhase 4NCT06248229

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

A Single Center, Flexible-Dose, 10-Week, Randomized, Double-Blinded, Placebo-Controlled, Clinical Trial To Study The Efficacy Of Dyanavel XR In Treating Co-Occurring Fatigue In Adults With Attention Deficit/Hyperactivity Disorder (ADHD)

Sponsor

Rochester Center for Behavioral Medicine

Enrollment

50 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Fatigue Attention Deficit Hyperactivity Disorder Attention Deficit Disorder

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a medication called Dyanavel XR (amphetamine extended-release) can reduce fatigue in adults who also have ADHD (attention deficit hyperactivity disorder). Many people with ADHD also struggle with persistent fatigue, and this trial explores whether treating ADHD helps with that exhaustion. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with ADHD - You score above the clinical threshold for both ADHD symptoms and fatigue on standardized questionnaires - You agree to use birth control during the study if sexually active **You may NOT be eligible if...** - You do not meet clinical criteria for ADHD - Your fatigue does not meet a minimum severity threshold - You have heart conditions or other serious medical problems that would make stimulant medication unsafe - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDyanavel XR

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.