Actively Recruiting
A Single Center, Flexible-Dose, 10-Week, Randomized, Double-Blinded, Placebo-Controlled Trial to Study the Efficacy of Dyanavel XR in Treating Fatigue in Adults With Attention Deficit/Hyperactivity Disorder
Led by Rochester Center for Behavioral Medicine · Updated on 2024-11-21
50
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the impact of Dyanavel XR on fatigue in adults diagnosed with Attention Deficit/Hyperactivity Disorder (ADHD). This clinical trial aims to determine if Dyanavel XR can reduce fatigue symptoms compared to a placebo. The study uses a randomized, double-blind, placebo-controlled design with flexible dosing over a 10-week period. Participants will be randomly assigned to receive either Dyanavel XR or a matching placebo, starting at 5 mg once daily in the morning. Dosage may be adjusted weekly or bi-weekly based on individual response and side effects, with the investigator available to guide dosing between Weeks 0 and 4. Tablets should be swallowed whole and can be taken with or without food. Throughout the study, participants will attend regular visits for symptom evaluation and side effect monitoring. Various assessments, including the Fatigue Symptom Inventory, Behavior Rating Inventory of Executive Functioning-Adult, ADHD Rating Scale, and other quality of life and sleep questionnaires, will be conducted at screening, baseline, and multiple weeks during treatment. Safety and efficacy will be closely monitored, and the study is expected to conclude by December 2026.
CONDITIONS
Brief Title
A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder (ADHD).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years at the time of consent
- Diagnosed with ADHD as determined by the SCID-5 ADHD module
- Fatigue Symptom Inventory average score greater than 3 on both interference and severity scales at screening
- Clinically significant ADHD-RS-IV score greater than 36 at screening
- Score of 4 or higher on the Clinical Global Impression-Severity scale at screening
- Able to swallow intact tablets
- Fluent in English with sufficient understanding to communicate with investigators
- Live within Michigan or commute up to 50 miles one-way to the study site
- Sexually active participants of childbearing potential agree to use two methods of birth control or remain abstinent during the trial and for 30 days after
- Negative pregnancy test for women of childbearing potential at screening
- Negative drug screen for illicit drugs except cannabis; must comply with washout for prohibited medications as instructed
- Able to provide written informed consent and comply with study procedures
- Minimum intellectual functioning without significant general intellectual deficit as assessed by the investigator
You will not qualify if you...
- Immediate family of the investigator or study affiliates
- Treatment with non-approved drugs or participation in other clinical trials within 30 days prior to screening
- Medical complications from being severely underweight or overweight
- Current uncontrolled comorbid psychiatric disorders requiring prohibited medications or behavioral programs
- Current suicide risk or suicide attempt within past two years
- History of substance abuse or drug dependence within one year, excluding nicotine and caffeine
- Positive test for illicit substances at screening
- Serious unstable medical or psychiatric conditions including cardiovascular, renal, hepatic, respiratory, hematologic illness, or narrow angle glaucoma
- History of seizure disorder (except infantile febrile seizures), tic disorders, or Tourette's disorder
- History of organic heart disease
- Likely to require addition of psychotropic medications during the study
- Previous enrollment in this study
- Anticipated relocation or extended travel inconsistent with visit schedule
- Taking excluded medications that cannot be discontinued prior to study start
- Known allergy or intolerance to amphetamine-based medications
- Use of MAOI within 14 days prior to study
- Recent (within 3 months) use of CNS stimulant medications
- Investigator judgment of unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 weeks
Participants receive Dyanavel XR or placebo once daily in the morning with flexible dosing adjustments based on weekly and bi-weekly evaluations. The dose is started at 5 mg and may be titrated up to 20 mg according to clinical judgment during the first 4 weeks.
Weekly visits for the first 4 weeks and bi-weekly visits thereafter
Trial Site Locations
Total: 1 location
1
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States, 48307
Actively Recruiting
Research Team
J
Jaime Saal, MA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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