NCT00783835

Study to Evaluate the Efficacy and Quality of Life of Long-Acting Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

A Multicenter Open Trial to Evaluate the Effectiveness and Quality of Life in Adults With Attention Deficit /Hyperactivity Disorder (ADHD) Treated With Long Acting Methylphenidate (CONCERTA)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Janssen-Cilag Farmaceutica Ltda. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Long-Acting Methylphenidate	Long-Acting Methylphenidate within the range of 18, 36, 54 and 76 milligram will be orally administered once daily up to Day 56.

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-11-03
• Last updated: 2013-07-23
• Results posted: 2013-07-23

Locations

5 sites across 1 country: Brazil