Safety and efficacy of dasotraline for patients with attention deficit/hyperactivity disorder: a systematic review and meta-analysis of 1594 patients including GRADE qualifications.

INTRODUCTION: Attention-deficit/hyperactivity disorder (ADHD) is a complex neurodevelopmental disorder. It is one of the most common mental disorders in youth worldwide characterized by persistent overactivity and impulsivity/inattention symptoms associated with social and academic impairment. dasotraline has been suggested to play a pivotal role as a serotonin, norepinephrine, and dopamine reuptake inhibitor. This study aimed to create evidence from published randomized clinical trials (RCTs) about the benefits of dasotraline for ADHD patients.

METHODS: A computer literature search (PubMed, Scopus, Web of Science, and Cochrane CENTRAL) was conducted. We included RCTs comparing dasotraline versus placebo. The primary outcome measure was the ADHD Rating Scale-IV score, pooled as the mean difference between the two groups from baseline to the endpoint. The secondary outcome measures were the ADHD Rating Scale-IV Inattention score, ADHD Rating Scale-IV Hyperactivity score.

RESULTS: Five RCTs with a total of 1594 patients were included in this study. dasotraline showed a significant improvement in the primary outcome (MD -2.65, 95% CI [-4.14 to -1.17], P= 0.0004 CONCLUSION: The results showed that dasotraline demonstrated a significant improvement in both primary and secondary outcomes, establishing its efficacy as a novel treatment for ADHD symptoms. However, mild to moderate side effects were observed.