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MIN-101 reduces negative symptoms in schizophrenia

MIN-101, a 5-HT_2a and sigma2 antagonist from Minerva Neurosciences, significantly reduced negative symptoms in schizophrenia and was well-tolerated, according to recent findings.

“Antipsychotic drugs such as amisulpride and, more recently, asenapine and cariprazine have been suggested to be beneficial for negative symptoms, but their specificity and advantages in this regard remain debatable,” Michael Davidson, MD, of the Tel Aviv University Sackler School of Medicine, Israel, and colleagues wrote. “On the other hand, some dopamine D₂ receptor blocking antipsychotic drugs produce secondary negative symptoms, which are not always easy to distinguish from primary negative symptoms.”

To determine efficacy, safety, and tolerability of MIN-101, researchers conducted a 12-week, randomized, double-blind, placebo-controlled trial among 244 individuals with schizophrenia who were symptomatically stable for at least 3 months. Study participants had scores of at least 20 on the negative subscale of the Positive and Negative Syndrome Scale (PANSS). After at least 5 days’ withdrawal from all antipsychotic treatment, participants were randomly assigned to receive 32 mg or 64 mg of MIN-101 per day or placebo for 12 weeks.

Participants who received 32 mg per day (effect size = 0.45) or 64 mg per day (effect size = 0.57) of MIN-101 exhibited significantly lower PANSS negative factor scores.

Participants who received MIN-101 exhibited superior improvement in PANSS negative symptom, total, and activation scores, the Clinical Global Impressions Scale severity item, and the Brief Negative Symptom Scale.

PANSS positive scale scores did not significantly differ between MIN-101 and placebo groups, according to researchers.

Further, there were no clinically significant changes in vital signs, routine laboratory values, weight, metabolic indices, and Abnormal Involuntary Movement Scale scores.

“This study is unique in reporting on a non-D2-receptor-blocking drug with specific therapeutic effects on negative symptoms of schizophrenia,” the researchers wrote. “The validity of these results is supported by findings related to the primary and secondary outcome measures and by the lack of potential confounders, such as improvements in extrapyramidal symptoms or positive symptoms and unblinding through the observation of adverse effects.” – by Amanda Oldt

Disclosure: Davidson reports employment and stock options with Minerva Neurosciences. Please see the study for a full list of relevant financial disclosures.