Zarinara 2010.
Methods | A 6‐week double‐blind, parallel‐group randomised clinical trial with 2 arms:
No control/no‐intervention group |
|
Participants | Number of participants screened: 60 Number of participants included: 38 Number randomised to methylphenidate: 19 Number of participants followed up in the methylphenidate group: 18 Number of withdrawals in the methylphenidate group: 1 MPH group Diagnosis of ADHD: DSM‐IV‐TR (subtype: combined (100%)) Age: mean 9.57 years old (range 6‐13) IQ: above 70 Sex: 13 males, 6 females Methylphenidate‐naïve: 100% (newly diagnosed) Ethnicity: Persian (100%) Country: Iran Comorbidity: not stated Comedication: not stated Sociodemographics: not stated Inclusion criteria:
Exclusion criteria:
|
|
Interventions | Methylphenidate type: not stated Methylphenidate dosage: 20‐30 mg/day depending on weight (20 mg/day for < 30 kg and 30 mg/day for > 30 kg) Methylphenidate titration: 3 weeks (week 1: 10 mg/day twice daily; week 2: 20 mg/day twice daily; and week 3: 30 mg/day for children > 30 kg 3 times daily) Duration of intervention: 6 weeks inclusive titration Treatment compliance: not stated |
|
Outcomes | Adverse effects checklist (20 possible adverse events), rated by a child psychiatrist on days 7, 21, 42. Body weight and vital signs assessed at baseline, week 1, 2, 4, 6. 12‐lead ECG and physical examination at baseline and week 6 | |
Notes | Sample calculation: not stated Ethics approval: yes Funding/vested interests/authors' affiliations: this study was supported by a grant from Tehran University of Medical Sciences Key conclusions of the study authors: the results suggest that venlafaxine may be useful for the treatment of ADHD. In addition, a tolerable side‐effect profile is one of the advantages of venlafaxine in the treatment of ADHD Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: no Supplemental information regarding data requested through personal communication with the authors in August 2013. No reply |