Status:
COMPLETED
Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Ortho-McNeil Janssen Scientific Affairs, LLC
Conditions:
ADHD
Eligibility:
All Genders
12-17 years
Phase:
PHASE4
Brief Summary
This study will consist of a six-week open-label treatment period with an extended duration methylphenidate (OROS MPH) followed by subsequent monthly visits for 24 months in a large sample of youths a...
Eligibility Criteria
Inclusion
- Adolescent outpatients between 12 to 17 years of age (inclusive).
- Subjects with the DSM-IV diagnosis of ADHD, as manifested in the clinical evaluation and confirmed by structured interview.
- Subjects with sufficient current ADHD symptoms to warrant treatment, as measured by a Clinical Global Impression Severity Scale (CGI-S) score of greater than or equal to 4 (moderately ill); OR subjects already on Concerta who are judged to be responders (CGI of 1 or 2) and who tolerate treatment well.
Exclusion
- Any serious or unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, hypertension), endocrinologic, neurologic, immunologic, or hematologic disease.
- Clinically significant abnormal baseline laboratory values
- History of seizures
- Active tic disorder
- Pregnant or nursing females
- Mental retardation (intelligence quotient \[IQ\] \< 75)
- Organic brain disorder
- Eating disorders
- Psychosis
- Current bipolar disorder (current episode)
- Current depression \> mild (CGI-S \> 3)
- Current anxiety \> mild (CGI-S \> 3)
- Substance abuse or dependence within the past 2 months
- Recent change in non-monoamine oxidase inhibitor (MAOI) antidepressants (\< 3 months)
- Recent change in benzodiazepines (\< 3 months)
- Concerta non-responder
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT00181714
Start Date
November 1 2003
End Date
January 1 2011
Last Update
May 7 2013
Active Locations (1)
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1
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138