Khodadust 2012.
Methods | A 6‐week randomised, double‐blind, parallel group study with 2 arms:
No control/no‐intervention group |
|
Participants | Number of participants screened: not stated Number of participants included: 30 Number of participants randomised to Ritalin: 15 and Stimdate: 15 Number followed up in each arm: Ritalin: 14 and Stimdate: 14 Number of withdrawals in each arm: Ritalin: 1 and Stimdate: 1 Diagnosis of ADHD: DSM‐IV‐TR (subtype: combined 100%) Age: Ritalin: 9.2 (0.5); Stimdate: 8.33 (0.5) IQ: above 70 Sex: Ritalin: 12 males, 3 females; Stimdate: 15 females Methylphenidate‐naïve: none Ethnicity: 100% Persian Comorbidity: none Comedication: none Sociodemographics: not stated Inclusion criteria:
Exclusion criteria:
|
|
Interventions | Participants were randomly assigned to 2 methylphenidate preparations: Ritalin or Stimdate Final mean methylphenidate dose: Ritalin (29.2 (SD 9.1) mg), Stimdate (31.4 (SD 8.6) mg) Administration schedule: morning and noon Duration of intervention: 6 weeks Titration period: 4 weeks initiated after randomisation Treatment compliance: not stated |
|
Outcomes |
Non‐serious adverse events: Nonserious adverse events checklist and telephone interviews asking about drug side effects were performed |
|
Notes | Sample calculation: not stated Ethics approval: not stated Funding/vested interests: none declared Key conclusions of the study authors: we recommend clinicians choose Ritalin or Stimdate according to the patient's preferences, sustained accessibility, primary response to treatment, and possible side effects encountered in course of treatment. This means that neither of these drugs has been proven to be superior to the other one Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes. See exclusion criteria 4 Supplemental information requested twice through email correspondence with the authors in June 2013. No reply |