Previous studies have shown l-methylfolate to be a safe and beneficial therapy for neuropsychiatric conditions, including major depressive disorder and schizophrenia in adults. The purpose of this study was to assess safety and describe patient experience using l-methylfolate calcium in a real-world pediatric and adolescent population. A retrospective chart review of patients (7 to 20 y of age, mean age 16 y) prescribed l-methylfolate calcium at a psychiatry clinic in Amherst, NY, between January 1, 2010 and November 10, 2015 was conducted. Patients to whom l-methylfolate calcium 15 mg/d (n=139) or 7.5 mg/d (n=7) was administered were identified; 44 patients who were prescribed but to whom l-methylfolate calcium was not administered were included as a comparator population. Common neuropsychiatric diagnoses included anxiety disorders (68% in the treatment population vs. 50% in the comparator population) and mood disorders (57% in the treatment population vs. 52% in the comparator population). Antidepressants (69% vs. 55%) and mood stabilizers or antiepileptic drugs (63% vs. 57%) were frequently prescribed in combination with l-methylfolate calcium. Adverse events occurred less frequently in the treated population, possibly due to the addition of l-methylfolate calcium (10% vs. 25%, P=0.02). The most common adverse events in the treated population were impaired sleep (5 patients) and increased anxiety (3 patients). Rates of laboratory abnormalities did not differ significantly between the treated and comparator populations (P=0.13). Positive subjective treatment experiences were reported by 22.5% of treated patients and negative subjective treatment experiences were reported by 5.4% of treated patients. L-methylfolate calcium was well-tolerated in a pediatric/adolescent population and may provide benefits for patients with a range of neuropsychiatric conditions.
RAINKA, ALADEEN, GENGO, CAPOTE: Dent Neurologic Institute, Amherst, NY, and State University of New York at Buffalo, Buffalo, NY
WESTPHAL: Dent Neurologic Institute, Amherst, NY
MEANEY and GREGER: State University of New York at Buffalo, Buffalo, NY
At the time of the study, J.M., and J.G. were students at the State University of New York at Buffalo School of Pharmacy and Pharmaceutical Sciences.
Supported by Nestle Health Science-Pamlab Inc., Covington, LA (a subsidiary of Alfasigma USA Inc.).
The authors declare no conflicts of interest.
Please send correspondence to: Traci Aladeen, PharmD, Dent Neurologic Institute, 3980 Sheridan Drive, Amherst, NY 14226 (e-mail: firstname.lastname@example.org).