Conditions: Attention Deficit Hyperactivity Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 43
Healthy volunteers: no

Brief summary:
This study will examine the efficacy and safety of HLD200 in patients age 6-12 years with ADHD using a classroom study design.

Detailed description:
The study consists of two distinct treatment phases. The first is the 6-week open-label, treatment optimization phase during which subjects are titrated to an optimal daily dose of HLD200. Subjects are then randomized to receive either optimal HLD200 or matched placebo treatment for an additional week prior to final testing during a laboratory school day.

Arms:
arm 1: HLD200 (methylphenidate hydrochloride) 20, 40, 60, 80, or 100 mg capsules

Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to continue their HLD200 treatment over an one week double-blind, placebo-controlled phase. HLD200 was administered orally, once daily each evening. arm 2: Placebo capsules (dose matched to HLD200 capsules)

Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to receive placebo treatment over a one week double-blind, placebo-controlled phase. Treatments were administered orally, once daily each evening.

Interventions: intervention 1: HLD200 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: