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Sponsors and Collaborators: |
Massachusetts General Hospital Eli Lilly and Company |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00181766 |
This is an open-label study with daily doses up to 144 mg/day Strattera in the treatment of adults with attention deficit hyperactivity disorder not otherwise specified. The researchers hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to Strattera treatment and Strattera treatment (in doses of up to 120 mg/day or 1.5 mg/kg/day, whichever is less) in adults with ADHD NOS will be safe and well tolerated.
Condition | Intervention | Phase |
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ADHD NOS |
Drug: atomoxetine (Strattera) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study of Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified |
Estimated Enrollment: | 30 |
Study Start Date: | December 2003 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Strattera (atomoxetine) is a non-stimulant specific norepinephrine reuptake inhibitor recently approved by the Food and Drug Administration for the treatment of child, adolescent and adult patients with ADHD. It is possible Strattera could be a viable alternative treatment for ADHD individuals. The purpose of this study is to assess the effectiveness, safety and tolerability of Strattera in adults with ADHD NOS. If this initial study shows promise, we will follow-up with a randomized clinical trial.
The study includes:
Primary outcomes measure symptom reduction.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects with the diagnosis of attention deficit hyperactivity disorder not otherwise specified (ADHD NOS), by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), as manifested in clinical evaluation and confirmed by structured interview. This is operationalized by either:
Exclusion Criteria:
Clinically significant abnormal baseline laboratory values which include the following:
Only English-speaking subjects will be allowed into the study for the following reasons:
Contact: Meghan Kotarski, BS | 617-503-1051 | mkotarski@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Cambridge, Massachusetts, United States, 02138 | |
Contact: Meghan Dougherty, BS 617-503-1051 mdougherty2@partners.org | |
Contact: Megan Aleardi, BA 617-503-1405 maleardi@partners.org | |
Principal Investigator: Joseph Biederman, MD |
Principal Investigator: | Joseph Biederman, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Joseph Biederman, MD ) |
Study ID Numbers: | 2003-P-002052 |
Study First Received: | September 13, 2005 |
Last Updated: | June 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00181766 |
Health Authority: | United States: Institutional Review Board |
ADHD NOS Adults Strattera Open-Label |
Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood |
Atomoxetine Attention Deficit and Disruptive Behavior Disorders Hyperkinesis |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents |
Adrenergic Uptake Inhibitors Physiological Effects of Drugs Pharmacologic Actions |