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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00181714
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : February 7, 2012
Last Update Posted : May 7, 2013
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 16, 2005
Results First Submitted Date  ICMJE January 5, 2012
Results First Posted Date  ICMJE February 7, 2012
Last Update Posted Date May 7, 2013
Study Start Date  ICMJE November 2003
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2012)
Cigarette Smoking [ Time Frame: 24 months ]
Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Prevention of Cigarette Smoking
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta
Official Title  ICMJE Prevention of Cigarette Smoking in ADHD Youth With Concerta
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 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE ADHD
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: OROS MPH
Single arm- open treatment with extended duration methylphenidate (OROS MPH)
Intervention: Drug: methylphenidate HCl (Concerta)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2011)
203
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
150
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00181714
Other Study ID Numbers  ICMJE 2003-P-001313
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joseph Biederman, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Ortho-McNeil Janssen Scientific Affairs, LLC
Investigators  ICMJE
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date May 2013

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