About 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.
Eligibility criteria
Qualifiers
At screening, all subjects must have a Fatigue Symptom Inventory average score on both of the interference and severity scales greater than 3.
At screening, all subjects must score in the clinically significant range on the ADHD-RS-IV, meaning a score greater than 36.
At screening, all subjects must meet criteria for an ADHD diagnosis as determined by the SCID-5 ADHD module.
All subjects must be 18-65 years of age at the time of consent.
Disqualifiers
Subjects must not be an immediate family of the Investigator or others directly affiliated with the study.
Subjects 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.
Subjects must not have medical complications arising from being severely underweight or overweight.
Subjects 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 psychiatric diagnoses will be assessed during a psychiatric intake and scoring of the SCID and MINI. The Investigator will review on a case by case basis.
Trial design
Treatments tested in this trial
- Dyanavel XR
- Placebo