Published in The Journal of Clinical Psychiatry, study data suggest that MIN-101 may improve cognitive deficits in individuals with clinically significant negative symptoms of schizophrenia.
Participants (n=244) aged 18 to 60 years with stable symptoms of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) and moderate to severe negative symptoms were randomly assigned to placebo (n=83), MIN-101 32 mg (n=78), or MIN-101 64 mg (n=83) in a 12-week, prospective, double-blind study. In a post hoc analysis, researchers assessed changes in z and T scores from baseline to 12 weeks in the cognitive composite score and in individual results on the Brief Assessment of Cognition in Schizophrenia (BACS). Results were compared across the placebo and MIN-101 study arms.
The BACS token motor (P =.04), verbal fluency (P =.01), and composite z scores (P =.05) were significantly improved over the course of the study in the MIN-101 32-mg group compared with the placebo group. At week 4, the clinical improvements from baseline in the negative factor of the Positive and Negative Syndrome Scale (PANSS) were significantly correlated with improvements from baseline on the BACS cognitive composite (P =.020) for the MIN-101 64 mg group. At week 12, this same relationship was observed in the 64-mg group (P =.002). In addition, at week 12 in the 64 mg-group, improvement in the PANSS negative factor was associated with improved verbal memory (P =.017) and with improvements in the Trail Making task, which measures attention and processing speed (P =.003). No similar correlations were observed in the 32-mg group at either of these time points.
Additional studies are needed to further elucidate the mechanism by which MIN-101 may alleviate certain negative symptoms and improve cognitive functioning in patients with schizophrenia. Researchers hope that in demonstrating the potential efficacy of MIN-101, they may improve the pharmacotherapy options available to patients with schizophrenia.
Disclosures: This study was funded by Minerva Neurosciences Inc. Please refer to the original article for disclosure information from the study authors.
Keefe RSE, Harvey PD, Khan A, et al. Cognitive effects of MIN-101 in patients with schizophrenia and negative symptoms: results from a randomized controlled trial. J Clin Psychiatry. 2018;79(3):17m11753.