TY - JOUR
T1 - Efficacy and safety of MIN-101
T2 - A 12-week randomized, double-blind, placebo-controlled trial of a new drug in development for the treatment of negative symptoms in schizophrenia
AU - Davidson, Michael
AU - Saoud, Jay
AU - Staner, Corinne
AU - Noel, Nadine
AU - Luthringer, Elisabeth
AU - Werner, Sandra
AU - Reilly, Joseph
AU - Schaffhauser, Jean Yves
AU - Rabinowitz, Jonathan
AU - Weiser, Mark
AU - Luthringer, Remy
N1 - Funding Information:
This phase 2b clinical trial was funded by Minerva Neurosciences.
PY - 2017/12/1
Y1 - 2017/12/1
N2 - Objective: The authors assessed the efficacy, safety, and tolerability of MIN-101, a compound with affinities for sigma- 2 and 5-HT2A receptors and no direct dopamine affinities, in comparison with placebo in treating negative symptoms in stabilized patients with schizophrenia. Method: The trial enrolled 244 patients who had been symptomatically stable for at least3monthsandhadscores 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 medication, patients were randomly assigned to receive placebo or 32 mg/day or 64 mg/day of MIN-101 for 12 weeks. The primary outcome measure was the PANSS negative factor score (pentagonal structure model). Secondary outcome measures were PANSS total score and scores on the Clinical Global Impressions Scale (CGI), the Brief Negative Symptom Scale, the Brief Assessment of Cognition in Schizophrenia, and the Calgary Depression Scale for Schizophrenia. Results: A statistically significant difference in PANSS negative factor score was observed, with lower scores for the MIN-101 32 mg/day and 64 mg/day groups compared with the placebo group (effect sizes, d=0.45 and d=0.57, respectively). Supporting these findings were similar effects on several of the secondary outcome measures, such as the PANSS negative symptom, total, and activation factor scores, the CGI severity item, and the Brief Negative Symptom Scale. There were no statistically significant differences in PANSS positive scale score between the MIN-101 and placebo groups. No clinically significant changes were observed in vital signs, routine laboratory values, weight, metabolic indices, and Abnormal Involuntary Movement Scale score. Conclusions: MIN-101 demonstrated statistically significant efficacy in reducing negative symptoms and good tolerability in stable schizophrenia patients.
AB - Objective: The authors assessed the efficacy, safety, and tolerability of MIN-101, a compound with affinities for sigma- 2 and 5-HT2A receptors and no direct dopamine affinities, in comparison with placebo in treating negative symptoms in stabilized patients with schizophrenia. Method: The trial enrolled 244 patients who had been symptomatically stable for at least3monthsandhadscores 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 medication, patients were randomly assigned to receive placebo or 32 mg/day or 64 mg/day of MIN-101 for 12 weeks. The primary outcome measure was the PANSS negative factor score (pentagonal structure model). Secondary outcome measures were PANSS total score and scores on the Clinical Global Impressions Scale (CGI), the Brief Negative Symptom Scale, the Brief Assessment of Cognition in Schizophrenia, and the Calgary Depression Scale for Schizophrenia. Results: A statistically significant difference in PANSS negative factor score was observed, with lower scores for the MIN-101 32 mg/day and 64 mg/day groups compared with the placebo group (effect sizes, d=0.45 and d=0.57, respectively). Supporting these findings were similar effects on several of the secondary outcome measures, such as the PANSS negative symptom, total, and activation factor scores, the CGI severity item, and the Brief Negative Symptom Scale. There were no statistically significant differences in PANSS positive scale score between the MIN-101 and placebo groups. No clinically significant changes were observed in vital signs, routine laboratory values, weight, metabolic indices, and Abnormal Involuntary Movement Scale score. Conclusions: MIN-101 demonstrated statistically significant efficacy in reducing negative symptoms and good tolerability in stable schizophrenia patients.
UR - http://www.scopus.com/inward/record.url?scp=85036621148&partnerID=8YFLogxK
U2 - 10.1176/appi.ajp.2017.17010122
DO - 10.1176/appi.ajp.2017.17010122
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AN - SCOPUS:85036621148
SN - 0002-953X
VL - 174
SP - 1195
EP - 1202
JO - American Journal of Psychiatry
JF - American Journal of Psychiatry
IS - 12
ER -