Actively Recruiting
A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder (ADHD).
Led by Rochester Center for Behavioral Medicine · Updated on 2024-11-21
50
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- 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
- Diagnosis of ADHD confirmed by SCID-5 ADHD module at screening
- Age between 18 and 65 years at time of consent
- Sexually active males or females of childbearing potential agree to use two birth control methods or remain abstinent during the trial and 30 days after
- Women of childbearing potential test negative for pregnancy at screening
- Residence in Michigan or ability to commute within 50 miles one way to study site
- Ability to swallow intact tablets
- Ability to understand and comply with study protocol, including assessments and dosage regimens
- Minimum intellectual functioning without significant general intellectual deficit
- Ability to provide written informed consent in English
- Fluency in English sufficient to communicate with study staff
- Negative drug screen for methamphetamine, cocaine, and illicit drugs except cannabis
- Score of 4 or higher on CGI-S at screening
You will not qualify if you...
- Immediate family of investigator or study affiliates
- Treatment with unapproved drugs or clinical trial participation within 30 days prior to screening
- Medical issues from being severely underweight or overweight
- Uncontrolled comorbid psychiatric disorders needing prohibited medication or behavioral programs
- Current suicide risk or suicide attempt within past two years
- History of substance abuse or dependence within past year except nicotine and caffeine
- Positive illicit substance test at screening
- Serious unstable medical conditions including cardiovascular, renal, hepatic, respiratory, or hematologic illness
- History of intellectual impairment or severe learning disability
- History of seizure disorder except infantile febrile seizures, tic disorder, or Tourette's disorder
- History of organic heart disease or congenital heart conditions
- Likely to add psychotropic medications apart from study drug during trial
- Previous enrollment in this study
- Plans to relocate or extended travel inconsistent with visit schedule
- Use of prohibited medications that cannot be stopped before treatment
- Known allergy or intolerance to amphetamine-based medications
- Use of MAO inhibitors within 14 days before study
- Use of medications likely to interfere with study drug efficacy or results
- Recent use of CNS stimulant medications within past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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