Novel Compound Shows Promise in Treating Negative Symptoms of Schizophrenia
MIN-101–a novel Chemical that binds into sigma-2 along with 5-HT2A receptors–appears to reduce negative symptoms of schizophrenia with No major side effects, according to a Research at AJP at Advance.
Unlike antipsychotics, MIN-101 has no direct activity on serotonin receptors.
While most present antipsychotics are good at treating the positive symptoms of the disorder (like hallucinations and delusions), controlling the adverse symptoms (like anhedonia) has shown more difficult.
To compare the safety and effectiveness of MIN-101 with placebo, Michael Davidson, M.D., of Minerva Neurosciences and colleagues recruited 244 patients with schizophrenia who had been symptomatically stable for at least three months and had scores of at least 20 about the negative subscale of the Positive and Negative Syndrome Scale (PANSS). Following at least five days of withdrawal in most antipsychotic medication, the patients were randomly assigned to receive placebo or MIN-101 daily (either at 32 mg/day or even 64 mg/day) for 12 months).
Following 12 months, the patients taking MIN-101 showed statistically significant improvements in their PANSS negative symptom scores (effect sizes of 0.45 and 0.57 for the high and low doses, respectively [signaling a moderate impact]), but no gaps in their positive symptom scores or their Abnormal Involuntary Movement Scale (AIMS) scores. In addition, no clinically significant changes were observed in vital signs, weight, and metabolic indices, the authors reported.
“A relevant clinical issue is whether the improvement of adverse symptoms mentioned here is specific and clinically meaningful. Really, it is possible that MIN-101 has a very favorable impact on mood. On the other hand, the impact of negative symptoms was maintained after controlling for depression, which suggests the effect was not synonymous with improvement in mood,” Davidson and colleagues wrote.
“In addition, in the current trial, there was not any significant improvement in positive symptoms. The AIMS scores were low and showed only small variations. Thus, the improvement in negative symptoms cannot be credited to improvements in extrapyramidal symptoms, at least with respect to dyskinetic symptoms.”
This phase 2b clinical trial was funded by Minerva Neurosciences, the programmer of MIN-101. The research authors have financial ties to the company.