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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Collaborator: |
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00181571 |
Purpose
This is a double-blind, placebo-controlled study using daily doses of up to 1.3 mg/kg/day of Concerta in the treatment of adults with the DSM-IV diagnosis of attention deficit hyperactivity disorder (ADHD) (childhood onset). We hypothesize ADHD symptomatology in adults with DSM-IV ADHD will be responsive to Concerta treatment and Concerta-associated response of ADHD symptomatology in adults will be sustained over time.
| Condition | Intervention | Phase |
|---|---|---|
|
ADHD |
Drug: methylphenidate HCl (Concerta) Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-Blind Comparison of Concerta and Placebo in Adults With Attention Deficit Hyperactivity Disorder |
| Enrollment: | 297 |
| Study Start Date: | June 2003 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Concerta
|
Drug: methylphenidate HCl (Concerta)
up to a maximum dose of 1.3 mg Concerta/kg/day, and not more than 144 mg/day for any subject regardless of weight.
Other Name: Concerta
|
|
Placebo Comparator: 2
Placebo
|
Drug: Placebo
up to a maximum dose of 1.3 mg Placebo /kg/day, and not more than 144 mg/day for any subject regardless of weight.
|
Concerta was specially developed to replace three-times-a-day IR methylphenidate, making it an ideal option for patients with ADHD. Moreover, the once-a-day administration of Concerta secures a steady delivery of methylphenidate across the day, minimizing the well-known risks of peaks and valleys of IR methylphenidate, which could offer an added advantage to the pharmacokinetic advantage of once-a-day administration. Despite these putative advantages, whether this new delivery system will lead to the same results as those documented with immediate-response methylphenidate in the treatments of adults with ADHD requires empirical corroboration. To this end we are conducting a randomized controlled clinical trial to evaluate the short- and medium-term safety and efficacy of Concerta in the treatment of adults with ADHD with and without co-morbid psychiatric disorders. We also wish to examine the role of genetics in predicting ADHD treatment response to Concerta. There is growing literature that supports the role of genetic factors in treatment response in youth with ADHD, and we seek to further explore this relationship in adults.
The proposed study includes the use of a 34-week design to document the response rate, assessment of the impact of Concerta on functional capacities (quality of life, psychosocial function) and cognition, and careful assessment of safety and tolerability.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Clinically significant abnormal baseline laboratory values which include the following:
Non-English speaking subjects will not be allowed into the study for the following reasons:
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Cambridge, Massachusetts, United States, 02138 | |
| Principal Investigator: | Janet Wozniak, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Janet Wozniak, MD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00181571 History of Changes |
| Other Study ID Numbers: | 2003-p-000037 |
| Study First Received: | September 13, 2005 |
| Last Updated: | July 12, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
ADHD Adults Concerta Double-Blind |
|
Hyperkinesis Attention Deficit Disorder with Hyperactivity Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Methylphenidate |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |