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Sponsors and Collaborators: |
Massachusetts General Hospital McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00181740 |
This will be an open label pilot study of Concerta in the treatment of adults with the diagnosis of Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS). We hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to Concerta treatment in the short term and Concerta-associated response of ADHD symptomatology in adults with ADHD NOS will be sustained over the medium term.
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 Concerta Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified |
Estimated Enrollment: | 30 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | July 2005 |
Concerta is a stimulant medication approved for the treatment of ADHD in children. We propose to study the safety and efficacy of Concerta therapy in adults with ADHD NOS. Adult ADHD NOS is operationalized by either
Our hypotheses will be examined in two phases of an open label, pilot study. Phase I of the study consists of a six-week acute effectiveness trial. Phase II consists of continuation for responders in which subjects who respond in Phase I will be re-assessed every four weeks for six months. Effectiveness will be measured by improvements in clinician-rated scales, including: ADHD Symptom Checklist, Clinical Global Impression: ADHD, and Global Assessment of Functioning.
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 DSM-IV, as manifested in clinical evaluation and confirmed by structured interview. This is operationalized by either
Subjects receiving non-MAOI antidepressants (e.g., SSRI’s, bupropion, venlafaxine), or benzodiazepines who have been on a stable regimen for > 3 months for any of the conditions listed above. Subjects taking SSRIs will be allowed into the study for the following reasons:
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:
United States, Massachusetts | |
Massachusetts General Hospital | |
Cambridge, Massachusetts, United States, 02138 |
Principal Investigator: | Joseph Biederman, MD | Massachusetts General Hospital |
Study ID Numbers: | 2003-P-001355 |
Study First Received: | September 13, 2005 |
Last Updated: | October 6, 2005 |
ClinicalTrials.gov Identifier: | NCT00181740 |
Health Authority: | United States: Institutional Review Board |
ADHD NOS Adults Concerta Open-Label |
Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Atomoxetine |
Methylphenidate 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 |