An open-label, single-arm pilot study evaluated the efficacy of the combined melatonin and memantine preparation (Miladean) as add-on therapy in 20 children and adolescents (aged 8-15 years) with cognitive and behavioral impairments within hyperkinetic conduct disorder (F90.1, n=7), schizotypal disorder (F21, n=10), and schizophrenia (F20, n=3). All patients received stable background therapy, to which Miladean was added (2 tablets sublingually at bedtime) for 8 weeks. Cognitive tests (Raven's Progressive Matrices, Stroop test, computerized Go/No-Go task), sleep quality questionnaire (modified Spiegel scale), and ADHD symptom scales (SNAP-IV) were used to assess outcomes. The drug demonstrated a favorable safety and tolerability profile. A statistically significant reduction in symptoms of inattention and hyperactivity-impulsivity on the SNAP-IV scale (p0.001), improved sleep quality (p=0.002), and increased reaction speed in the Go/No-Go task (p=0.001-0.033) were observed. A trend towards improved performance on the intelligence test (Raven's Progressive Matrices, p=0.067-0.077) was noted. The preliminary data obtained at this study indicate the potential efficacy of Miladean in correcting cognitive and behavioral impairments in children across various diagnostic categories and justify conducting further double-blind, placebo-controlled studies.
Goryunov et al. (Thu,) studied this question.