Altin 2013.
Methods | A observational, prospective and non‐interventional study of methylphenidate, atomoxetine and nootropic medication use for 12 months | |
Participants | Number of participants screened: not stated Number of participants included: 546 Number of participants randomised: methylphenidate: 221. Atomoxetine: 234. Nootropic medicine: 91 Number followed‐up in each arm: methylphenidate: 133 (60.2%). Atomoxetine: 146 (62.4%). Nootropic med: 77 (84.6%) Number of withdrawals in each arm: methylphenidate: 52. Atomoxetine: 59. Nootropic med: 16 Diagnosis of ADHD: DSM‐IV‐TR (subtype: not stated) Age: mean: 9.6 (2.8) + 9.9 (2.7) + 9.4 (2.5), range: 6‐17 years old IQ: not stated Sex: male: 206 (88.0%) 180 (81.4%) 70 (76.9%) Methylphenidate‐naïve: not stated Ethnicity: white 129 (55.1%) + 93 (42.1%) + 91 (100.0%); Asian: 102 (43.6%) + 128 (57.9%) + 0 (0.0%); Black or African American: 2 (0.9%) + 0 (0.0%) + 0 (0.0%); other: 1 (0.4%) + 0 (0.0%) + 0 (0.0%). Country: Russian Federation, China, Taiwan, Egypt, United Arab Emirates, and Lebanon Setting: outpatient clinic Comorbidity: yes Comedication: yes Sociodemographics: not stated Inclusion criteria:
Exclusion criteria: Discontinuation of the original prescribed monotherapy |
|
Interventions | Methylphenidate type: not stated Methylphenidate dosage: not stated Administration schedule: not stated Duration of intervention: 12 months Treatment compliance: not stated |
|
Outcomes |
Non‐serious adverse events: 3 patients discontinued treatment in the methylphenidate group due to headache, anxiety and depressed mood |
|
Notes | Sample calculation: yes Ethics approval: yes Funding/vested interest: sponsored by Eli Lilly Authors' affiliations: Eli Lilly Neuroscience, Eli Lilly & Company Turkey; Eli Lilly Egypt; Eli Lilly Canada; Lilly Research Laboratories, Indianapolis; Eli Lilly and Company, Hungary; Dept. of Neurology, Neurosurgery and Medical Genetics of Pediatric Faculty, Moscow, Russian Federation; Dept of Psychological Medicine, Children's Hospital of Fudan University, Shanghai, China Key conclusions of the study authors: after 12 months of treatment, clinical and functional outcomes were improved in children and adolescents from non‐Western countries who initiated and remained on their prescribed pharmacological monotherapy Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: not stated Supplemental information requested from the study authors twice in June 2016 with no answer |