Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: ADHD
Intervention: methylphenidate HCl (Concerta) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s): Joseph Biederman, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
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 aged 12-17 who meet Diagnostic and Statistical Manual of Mental Disorders,
Fourth Edition (DSM-IV) criteria for ADHD.
The researchers hypothesize that OROS MPH treatment will be associated with low rates of
cigarette smoking in ADHD youth.
Clinical Details
Official title: Prevention of Cigarette Smoking in ADHD Youth With Concerta
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Cigarette Smoking
Eligibility
Minimum age: 12 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Adolescent outpatients between 12 to 17 years of age (inclusive).
2. Subjects with the DSM-IV diagnosis of ADHD, as manifested in the clinical evaluation
and confirmed by structured interview.
3. 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 Criteria:
1. Any serious or unstable medical illness including hepatic, renal, gastroenterologic,
respiratory, cardiovascular (including ischemic heart disease, hypertension),
endocrinologic, neurologic, immunologic, or hematologic disease.
2. Clinically significant abnormal baseline laboratory values
3. History of seizures
4. Active tic disorder
5. Pregnant or nursing females
6. Mental retardation (intelligence quotient [IQ] < 75)
7. Organic brain disorder
8. Eating disorders
9. Psychosis
10. Current bipolar disorder (current episode)
11. Current depression > mild (CGI-S > 3)
12. Current anxiety > mild (CGI-S > 3)
13. Substance abuse or dependence within the past 2 months
14. Recent change in non-monoamine oxidase inhibitor (MAOI) antidepressants (< 3 months)
15. Recent change in benzodiazepines (< 3 months)
16. Concerta non-responder
Locations and Contacts
Massachusetts General Hospital, Cambridge, Massachusetts 02138, United States
Additional Information
Starting date: November 2003
Last updated: May 2, 2013
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