Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246207
Status:
COMPLETED
Last Update Posted:
2012-02-10
First Post:
2005-10-28
Brief Title:
CONCERTA OROS Methylphenidate Hydrochloride for the Treatment of Attention Deficit Hyperactivity Disorder in Adults
Sponsor:
Janssen-Ortho Inc Canada
Organization:
Janssen-Ortho Inc Canada
Study Overview
Official Title:
An Open-label Study Evaluating the Safety and Effectiveness of OROS Methylphenidate Hydrochloride CONCERTA in Adults With Attention Deficit Hyperactivity Disorder
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this pilot study is to evaluate the safety tolerability and potential effectiveness of CONCERTAÂ methylphenidate hydrochloride extended-release tablets a central nervous system CNS stimulant for the treatment of adults with Attention Deficit Hyperactivity Disorder ADHD
Detailed Description:
CONCERTA is a long-acting form of methylphenidate a CNS stimulant Methylphenidate is a recognized first-line treatment for ADHD in children and adolescents It is widely acknowledged in the scientific literature that the disorder often will persist in adulthood and is associated with significant morbidity and undesirable outcomes Despite this few studies have been conducted to investigate the efficacy and safety of stimulant therapy in treating ADHD in adults As a consequence drug treatment options for adult sufferers of ADHD are limited The primary objective of this pilot open-label study is to evaluate the safety tolerability and potential effectiveness of CONCERTA 18 36 54 or 72 mg of methylphenidate hydrochloride administered once-daily in adult subjects with Attention Deficit Hyperactivity Disorder ADHD Patients cannot have been treated with any methylphenidate- or amphetamine-containing medication within 4 weeks of screening visit Once deemed eligible subjects will be started on 18 mg of CONCERTA once-daily for 3 days titrated up on Day 4 to 36 mg and maintained at this dose for 7 days Depending on patient response the dose of CONCERTA can continue to be titrated up every 7 days first to 54 mg and then to a maximum of 72 mg per day in order to achieve the optimal dose for each patient The primary efficacy outcomes will be the changes from baseline to the end of treatment in the inattention and hyperactivityimpulsivity subscale scores of the investigator-rated Conners Adult ADHD Rating Scale CARRS Safety and tolerability will be monitored throughout the study The study hypothesis is that stimulant therapy in treating adult ADHD will be safe and effective measured by the Conners Adult ADHD Rating Scale CAARS score CONCERTA is taken orally once-daily Starting with CONCERTA 18 mg for 3 days subjects are titrated up on Day 4 to 36 mg for 7 days Depending on response tolerability and clinicians discretion the dose of CONCERTA can continue to be titrated up every 7 days first to 54 mg and then to a maximum of 72 mg per day two 36 mg tablets until each subjects optimal dose is achieved The titration period will last a maximum of 24 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None