Hallucinations and other psychotic symptoms may arise in children and adolescents treated with methylphenidate (multiple brands) for attention-deficit/hyperactivity disorder (ADHD), new research suggests.
The meta-analysis, which included 10 randomized controlled trials, 17 nonrandomized studies, and 18 patient reports, showed that 1% to 2.5% of participants experienced such troublesome symptoms. However, investigators emphasize that the quality of the data in the included studies is subpar and that there is a possibility of bias.
Therefore, the results do not provide definitive proof of an association between methylphenidate and increased risk for psychotic symptoms, they write.
Nonetheless, until more definitive findings become available, “physicians, patients, and their caregivers should be aware of this possible adverse event,” lead author Erica Ramstad, a pregraduate research student in the Department of Children and Youth Psychiatry, Psychiatric Research Unit, Region Zeland, Denmark, told Medscape Medical News.
“However, concerns about this rare possible adverse event should of course be balanced against the potential beneficial effects of methylphenidate on ADHD symptoms, general behavior, and quality of life,” Ramstad added.
The study was published online July 10 in the Scandinavian Journal of Child and Adolescent Psychiatry and Psychology.
First-Line Therapy
Methylphenidate and other psychostimulants are the recommended first-line therapy for ADHD in multiple guidelines.
Previous studies have reported psychotic symptoms in children and adolescents treated with this agent for ADHD. However, Ramstad and colleagues note that to the best of their knowledge, no previous systematic review of the literature has examined psychotic symptoms in this patient population.
“Because so many children and adolescents are prescribed methylphenidate, it is important that the risk of adverse events is better understood,” they write.
The investigators examined two previous Cochrane systematic reviews that assessed the safety and efficacy of methylphenidate in children and adolescents with ADHD.
One review assessed randomized clinical trials; the other, which is currently in press, included observational studies, randomized trials without a placebo or comparator group, and patient reports.
The researchers updated these systematic reviews with additional randomized clinical trials published through March 2017.
The study included 1103 participants from randomized clinical trials, another 76,237 participants from nonrandomized studies, and 12 reports or small series describing 18 additional patients.
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