Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder Methylphenidate Concerta CONQoL
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 60
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and to assess the impact of the treatment on quality of life of long-acting methylphenidate in adult participants with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a clinical condition beginning in childhood and is characterized by inadequate levels of attention, hyperactivity and impulsiveness.

Detailed description:
This is an open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study), single arm study of multiple doses of long-acting methylphenidate in participants with ADHD. The study will consist of 2 phases; a screening phase and a treatment phase. The duration of participation in the study for an individual participant will be up to 12 weeks. Participants will be given 18 milligram (mg) of long-acting methylphenidate daily in the morning and titrated up (slow increase in drug dosage guided by participant's responses) to 36 mg per day (mg/day) on Day 8. Depending on response, tolerability and clinician's judgment, the dose could be escalated to the next dose level of 54 mg/day on Day 28 to a maximum of 72 mg/day on Day 56, until each participant achieved optimal dose. Participant's safety will be monitored throughout the study.

Arms:
arm 1: None

Interventions: intervention 1: Long-Acting Methylphenidate
Intervention descriptions: intervention 1: Long-Acting Methylphenidate within the range of 18, 36, 54 and 76 milligram will be orally administered once daily up to Day 56.

Protocol document: