50
Participants
Start Date
September 1, 2024
Primary Completion Date
September 1, 2026
Study Completion Date
December 1, 2026
Dyanavel 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."
Placebo
"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."
RECRUITING
Rochester Center for Behavioral Medicine, Rochester Hills
Rochester Center for Behavioral Medicine
OTHER