Table 3.
Study | Adler et al31 | Cherland and Fitzpatrick63 | Karabekiroglu et al59 | PATS group40–42 | Ramtvedt et al64 |
---|---|---|---|---|---|
Study design | Open-label | Retrospective | Open-label | Crossover, parallel | Crossover |
Treatment period | 6–12 months | 21 months | 15 days | 70 weeks | 6 weeks |
Follow-up | No | No | No | Yes | No |
Patients completed | 550 | 98 | 90 | 165 | 34 |
Age, years | 18–65 | 4–17 | 5–15 | 3.5–5 | 11.3 |
Placebo group | No | No | No | Yes | Yes |
Methylphenidate-naïve | No | Not known | Yes | Yes | Yes |
Limit for symptoms | 10% | Not known | Not known | 15 most frequent | Not known |
Changes in behavior | 1.8% | Single cases | No | Yes | Yes |
Focus of study | Changes in behavior in relation to long-term safety of methylphenidate | Psychotic side effects of methylphenidate | Short-term side effects of methylphenidate | Safety and tolerability of methylphenidate | Use of methylphenidate in minimizing adverse events |
Notes: For Adler et al, changes in behavior were mentioned in the article, but are not shown in the tables.31 For Cherland and Fitzpatrick, it was impossible to determine with certainty whether the behavioral changes observed were reversible.63 The Karabekiroglu et al study was specifically designed to study short-term effects.59 Subjects in the PATS group studies used methylphenidate off-label because of their age.40–42 In Ramtvedt et al, methylphenidate treatment was limited to 2 weeks.64