Expired Study
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Cambridge, Massachusetts 02138


Purpose:

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.


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


Study is Available At:


Original ID:

2003-P-001313


NCT ID:

NCT00181714


Secondary ID:


Study Acronym:


Brief Title:

Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta


Official Title:

Prevention of Cigarette Smoking in ADHD Youth With Concerta


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

12 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Massachusetts General Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Interven


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

203


Enrollment Type:

Actual


Overall Contact Information

Official Name:Paul Hammerness, MD
Principal Investigator
Massachusetts General Hospital

Study Dates

Start Date:November 2003
Completion Date:January 2011
Completion Type:Actual
Primary Completion Date:January 2011
Primary Completion Type:Actual
Verification Date:October 2012
Last Changed Date:October 30, 2012
First Received Date:September 13, 2005
First Results Date:January 5, 2012

Study Outcomes

Outcome Type:Primary Outcome
Measure:Cigarette Smoking
Time Frame:24 months
Safety Issues:False
Description:Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)

Study Interventions

Intervention Type:Drug
Name:methylphenidate HCl (Concerta)
Description:OROS MPH will be openly prescribed to a maximum of 1.5 mg/kg/day (maximum 126 mg/day). Doses will be titrated according to clinical assessment of efficacy and tolerability.
Arm Name:OROS MPH
Other Name:Concerta

Study Arms

Study Arm Type:Experimental
Arm Name:OROS MPH
Description:Single arm- open treatment with extended duration methylphenidate (OROS MPH)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Massachusetts General Hospital
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Ortho-McNeil Janssen Scientific Affairs, LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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