A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder (ADHD).

Part of paid clinical trials in Rochester Hills, Michigan.

Sponsor
Rochester Center for Behavioral Medicine
Study ID
NCT06248229
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Dyanavel XR — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 1, 2024
Status verified
Nov 2024
Primary completion
Sep 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dyanavel XR (Active Agent)
    Dyanavel 5, 10, 15 or 20 mg once daily in the morning
  • Placebo Comparator: Placebo
    Matching placebo 5, 10, 15 or 20 mg once daily in the morning

Primary Outcome Measure

Fatigue Symptom Inventory (FSI) [ Time Frame: Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rochester Center for Behavioral MedicineRochester HillsMichigan48307-

Find similar trials in Rochester Hills, MI

By condition
ADHD
By specialty
PsychiatryMental healthBehavioral health
By research site
Rochester Center for Behavioral Medicine· Rochester Hills, MI

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