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.
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.
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.
Parallel
Dyanavel XR
DrugDosing 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.
Placebo
DrugDosing 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.
Fatigue Symptom Inventory (FSI)
Rating scale completed by study coordinator or PI. Score would be 0-10 with 10 being a worse outcome.
Behavior Rating Inventory of Executive Functioning- Adult (BRIEF-A)
Rating scale to assess subject's cognitive functioning. T scores are used to interpret the individual's level of executive functioning, and are derived from their raw scores. T-scores of 65 or over are considered clinically significant.
ADHD Rating Scale (ADHD-RS)
Rating scale to evaluate symptoms of adult ADHD. Scores range from 0-54, with higher scores indicates a worse outcome.
ADHD Quality of Life Scale (ADHDQOL)
Rating scale to assess quality of life, with possible scores ranging from 0-100. Higher scores are indicative of a better outcome.
Clinical Global Impression Scales (CGI)
Clinician's subjective rating of subject's severity on a 7-point likert scale from 0-7, with higher scores indicative of a worse outcome.
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