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

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00181714
First received: September 13, 2005
Last updated: May 2, 2013
Last verified: May 2013

September 13, 2005
May 2, 2013
November 2003
January 2011   (final data collection date for primary outcome measure)
Cigarette Smoking [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)
Prevention of cigarette smoking
Complete list of historical versions of study NCT00181714 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta
Prevention of Cigarette Smoking in ADHD Youth With Concerta

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
ADHD
Drug: methylphenidate HCl (Concerta)
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.
Other Name: Concerta
Experimental: OROS MPH
Single arm- open treatment with extended duration methylphenidate (OROS MPH)
Intervention: Drug: methylphenidate HCl (Concerta)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
203
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00181714
2003-P-001313
Yes
Joseph Biederman, MD, Massachusetts General Hospital
Massachusetts General Hospital
Ortho-McNeil Janssen Scientific Affairs, LLC
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
Massachusetts General Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP