Hammerness 2012.

Methods	A longitudinal treatment study, receiving daily doses of osmotic release oral system for 6 weeks
Participants	Number of participants screened: 27 Number of participants included: 20 Number of participants followed up: 10 Number of withdrawals: 10 Diagnosis of ADHD: DSM‐IV‐TR Age: mean 14.2, range 12‐17 years old IQ: > 75 Sex: not stated (majority males) Methylphenidate‐naïve: 10% Ethnicity: not stated Country: USA Comorbidity: medically healthy Comedication: no Sociodemographics: not stated Inclusion criteria Male or female. 12‐17 years of age ADHD participants must meet the study criteria for the 'Prevention of Cigarette Smoking in ADHD Youth with CONCERTA Protocol' Each participant and his/her authorised legal representative must understand the nature of this proposed study, and must sign informed consent and informed assent documents Participant and parents must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with study procedures Exclusion criteria Clinically significant chronic medical condition including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischaemic heart disease), endocrinologic, neurologic, immunologic, or haematologic disease Organic brain disorders or mental retardation (IQ < 75) Contraindication to MRI including presence of metal or surgical devices (plates, implants, braces or other items) Pregnancy; women of child bearing potential must be using a medically approved method of birth control. Women of child bearing potential will receive a urinary pregnancy test prior to each MR scanning session Severe phobia of being in small, enclosed spaces Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild will not be eligible to participate in the treatment arm of the study Participants with active, clinically significant psychiatric comorbidity Participants were dropped from the study if in the investigators' opinion there was lack of efficacy, intolerable adverse events and/or clinically significant laboratory values, pregnancy, clinical worsening, or noncompliance with the study protocol
Interventions	Methylphenidate type: osmotic release oral system Mean methylphenidate dosage: 54 mg/day (0.90 mg/kg/day). Doses were clinically adjusted up to a maximal dose of 1.5 mg/kg/day, according to tolerability and symptoms, until the participant achieved an ADHD‐specific Clinical Global Impression Scale‐Improvement score of 1‐2 Administration schedule: daily Duration of intervention: 6 weeks Treatment compliance: not stated Wash out period prior to study: prior medication for ADHD participants was discontinued 1‐4 weeks prior to the initial study scan
Outcomes	Non‐serious adverse events: Adverse events were systematically collected
Notes	Sample calculation: no Ethics approval: yes, approved by the Massachusetts General Hospital and McLean Hospital Institutional Review boards Funding: this work was supported in part by the Pediatric Psychopharmacology Council Fund and by McNeil Pharmaceuticals Vested interest/authors' affiliations: the authors have several affiliations to the medical industry both as researchers, speakers, consultants, etc. Key conclusions of the study authors: these preliminary findings suggest the presence of glutamatergic abnormalities in adolescents with ADHD, which may normalise with methylphenidate treatment. Documented clinical improvement and endpoint symptomatology by and ADHD‐specific rating scale Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes