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| Name | Class |
|---|---|
| Ortho-McNeil Janssen Scientific Affairs, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OROS MPH | Experimental | Single arm- open treatment with extended duration methylphenidate (OROS MPH) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylphenidate HCl (Concerta) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cigarette Smoking | Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ) | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Biederman, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Cambridge | Massachusetts | 02138 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23639146 | Derived | Hammerness P, Fried R, Petty C, Meller B, Biederman J. Assessment of cognitive domains during treatment with OROS methylphenidate in adolescents with ADHD. Child Neuropsychol. 2014;20(3):319-27. doi: 10.1080/09297049.2013.790359. Epub 2013 May 2. | |
| 21143432 | Derived | Hammerness P, Biederman J, Petty C, Henin A, Moore CM. Brain biochemical effects of methylphenidate treatment using proton magnetic spectroscopy in youth with attention-deficit hyperactivity disorder: a controlled pilot study. CNS Neurosci Ther. 2012 Jan;18(1):34-40. doi: 10.1111/j.1755-5949.2010.00226.x. Epub 2010 Dec 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | OROS-Methylphenidate | Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Signed Consent/Enrolled |
| |||||||||||||
| Began Treatment With OROS-MPH |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OROS-Methylphenidate | Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cigarette Smoking | Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ) | Clinical trial subjects included in this analysis included those adolescents who took at least one dose of OROS MPH following baseline assessment (N=154), with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule of 24 months | Posted | Number | percent | 24 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OROS-Methylphenidate | Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| leg fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| TMJ | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
The main limitation of this report stems from its uncontrolled, open-label design. Thus, we cannot assert a causal relationship between lower smoking rates and OROS MPH prescription.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Hammerness, MD | Massachusetts General Hospital | 617-503-1063 | phammerness@partners.org |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D000073869 | Tobacco Smoking |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| 19394037 | Derived | Hammerness P, Wilens T, Mick E, Spencer T, Doyle R, McCreary M, Becker J, Biederman J. Cardiovascular effects of longer-term, high-dose OROS methylphenidate in adolescents with attention deficit hyperactivity disorder. J Pediatr. 2009 Jul;155(1):84-9, 89.e1. doi: 10.1016/j.jpeds.2009.02.008. Epub 2009 Apr 25. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 5 |
| 154 |
| 45 |
| 154 |
| viral illness | General disorders | Non-systematic Assessment |
|
| spontaneous pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| unintentional carbon monoxide poisoning | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| allergies | General disorders | Non-systematic Assessment |
|
| anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| asthma attack | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| back pain | General disorders | Non-systematic Assessment |
|
| jumbled thoughts | General disorders | Non-systematic Assessment |
|
| chest pain | General disorders | Non-systematic Assessment |
|
| cold symptoms | General disorders | Non-systematic Assessment |
|
| congestion | General disorders | Non-systematic Assessment |
|
| costosternal muscle strain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| cranky | General disorders | Non-systematic Assessment |
|
| decreased appetite | General disorders | Non-systematic Assessment |
|
| decreased energy | General disorders | Non-systematic Assessment |
|
| deer tick bite | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| dental infection | Infections and infestations | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| dizziness | General disorders | Non-systematic Assessment |
|
| dull | General disorders | Non-systematic Assessment |
|
| ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
|
| foot pain | General disorders | Non-systematic Assessment |
|
| hand lesion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| headache | General disorders | Non-systematic Assessment |
|
| heart racing | General disorders | Non-systematic Assessment |
|
| hoarse voice | General disorders | Non-systematic Assessment |
|
| hot/cold flashes | General disorders | Non-systematic Assessment |
|
| hyper | General disorders | Non-systematic Assessment |
|
| increased urination | Renal and urinary disorders | Non-systematic Assessment |
|
| infected ingrown tonail | Infections and infestations | Non-systematic Assessment |
|
| inflamed adenoids | General disorders | Non-systematic Assessment |
|
| initial insomnia | General disorders | insomnia | Non-systematic Assessment |
|
| insomnia | General disorders | Non-systematic Assessment |
|
| irritable | General disorders | Non-systematic Assessment |
|
| jittery | General disorders | Non-systematic Assessment |
|
| knee pain | General disorders | Non-systematic Assessment |
|
| lightheadedness | General disorders | Non-systematic Assessment |
|
| low interest | General disorders | Non-systematic Assessment |
|
| menstrual cramps | Reproductive system and breast disorders | Non-systematic Assessment |
|
| moody | General disorders | Non-systematic Assessment |
|
| muscle aches | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| nose bleed | General disorders | Non-systematic Assessment |
|
| orthodontic pain | General disorders | Non-systematic Assessment |
|
| otitis | General disorders | Non-systematic Assessment |
|
| pain extension in bilateral arms/legs | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| phinorhea | General disorders | Non-systematic Assessment |
|
| rapid pulse | General disorders | Non-systematic Assessment |
|
| rash (poison ivy) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| runny nose | General disorders | Non-systematic Assessment |
|
| sad | General disorders | Non-systematic Assessment |
|
| shoulder pain | General disorders | Non-systematic Assessment |
|
| sore throat | General disorders | Non-systematic Assessment |
|
| stomach ache | Gastrointestinal disorders | Non-systematic Assessment |
|
| teary | General disorders | Non-systematic Assessment |
|
| tense | General disorders | Non-systematic Assessment |
|
| tight breathing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| toothache | General disorders | Non-systematic Assessment |
|
| twisted ankle pain | General disorders | Non-systematic Assessment |
|
| upper respiratory infection | Infections and infestations | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| weight loss | General disorders | Non-systematic Assessment |
|
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| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |