Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 275
Healthy volunteers: no

Brief summary:
The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and 37.5 mg) given to participants daily in the morning compared to placebo in the treatment of adults aged 18 to 55 years diagnosed with ADHD.

Detailed description:

Arms:
arm 1: Subjects will receive SHP465 12.5 mg arm 2: Subjects will receive SHP465 titrated up to 37.5 mg arm 3: Subjects will receive matching placebo

Interventions: intervention 1: SHP465 12.5mg capsules (one capsule daily) intervention 2: Placebo intervention 3: SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)
Intervention descriptions: intervention 1: one capsule daily intervention 2: Matching placebo capsule that appears identical in size, weight, shape, and color (one capsule daily) intervention 3: One capsule daily

Protocol document: