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Published Online: 28 July 2017

Efficacy and Safety of MIN-101: A 12-Week Randomized, Double-Blind, Placebo-Controlled Trial of a New Drug in Development for the Treatment of Negative Symptoms in Schizophrenia

Abstract

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 least 3 months and 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 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.

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Information & Authors

Information

Published In

Go to American Journal of Psychiatry
Go to American Journal of Psychiatry
American Journal of Psychiatry
Pages: 1195 - 1202
PubMed: 28750582

History

Received: 30 January 2017
Revision received: 21 April 2017
Revision received: 11 May 2017
Revision received: 26 May 2017
Accepted: 1 June 2017
Published online: 28 July 2017
Published in print: December 01, 2017

Keywords

  1. Schizophrenia
  2. Negative Symptoms
  3. MIN-101
  4. Sigma Receptors
  5. 5HT2 Receptors

Authors

Details

Michael Davidson, M.D. [email protected]
From the Department of Psychiatry, Tel Aviv University Sackler School of Medicine, Tel Aviv, Israel; PPRS Research, Rouffach, France; Minerva Neurosciences, Waltham, Mass.; and the Louis and Gabi Weisfeld School of Social Work, Faculty of Social Sciences, Bar Ilan University, Ramat Gan, Israel.
Jay Saoud, Ph.D.
From the Department of Psychiatry, Tel Aviv University Sackler School of Medicine, Tel Aviv, Israel; PPRS Research, Rouffach, France; Minerva Neurosciences, Waltham, Mass.; and the Louis and Gabi Weisfeld School of Social Work, Faculty of Social Sciences, Bar Ilan University, Ramat Gan, Israel.
Corinne Staner, M.D.
From the Department of Psychiatry, Tel Aviv University Sackler School of Medicine, Tel Aviv, Israel; PPRS Research, Rouffach, France; Minerva Neurosciences, Waltham, Mass.; and the Louis and Gabi Weisfeld School of Social Work, Faculty of Social Sciences, Bar Ilan University, Ramat Gan, Israel.
Nadine Noel, Ph.D.
From the Department of Psychiatry, Tel Aviv University Sackler School of Medicine, Tel Aviv, Israel; PPRS Research, Rouffach, France; Minerva Neurosciences, Waltham, Mass.; and the Louis and Gabi Weisfeld School of Social Work, Faculty of Social Sciences, Bar Ilan University, Ramat Gan, Israel.
Elisabeth Luthringer, R.N.
From the Department of Psychiatry, Tel Aviv University Sackler School of Medicine, Tel Aviv, Israel; PPRS Research, Rouffach, France; Minerva Neurosciences, Waltham, Mass.; and the Louis and Gabi Weisfeld School of Social Work, Faculty of Social Sciences, Bar Ilan University, Ramat Gan, Israel.
Sandra Werner, Ph.D.
From the Department of Psychiatry, Tel Aviv University Sackler School of Medicine, Tel Aviv, Israel; PPRS Research, Rouffach, France; Minerva Neurosciences, Waltham, Mass.; and the Louis and Gabi Weisfeld School of Social Work, Faculty of Social Sciences, Bar Ilan University, Ramat Gan, Israel.
Joseph Reilly, M.S.
From the Department of Psychiatry, Tel Aviv University Sackler School of Medicine, Tel Aviv, Israel; PPRS Research, Rouffach, France; Minerva Neurosciences, Waltham, Mass.; and the Louis and Gabi Weisfeld School of Social Work, Faculty of Social Sciences, Bar Ilan University, Ramat Gan, Israel.
Jean-Yves Schaffhauser, Pharm.D.
From the Department of Psychiatry, Tel Aviv University Sackler School of Medicine, Tel Aviv, Israel; PPRS Research, Rouffach, France; Minerva Neurosciences, Waltham, Mass.; and the Louis and Gabi Weisfeld School of Social Work, Faculty of Social Sciences, Bar Ilan University, Ramat Gan, Israel.
Jonathan Rabinowitz, Ph.D.
From the Department of Psychiatry, Tel Aviv University Sackler School of Medicine, Tel Aviv, Israel; PPRS Research, Rouffach, France; Minerva Neurosciences, Waltham, Mass.; and the Louis and Gabi Weisfeld School of Social Work, Faculty of Social Sciences, Bar Ilan University, Ramat Gan, Israel.
Mark Weiser, M.D.
From the Department of Psychiatry, Tel Aviv University Sackler School of Medicine, Tel Aviv, Israel; PPRS Research, Rouffach, France; Minerva Neurosciences, Waltham, Mass.; and the Louis and Gabi Weisfeld School of Social Work, Faculty of Social Sciences, Bar Ilan University, Ramat Gan, Israel.
Remy Luthringer, Ph.D.
From the Department of Psychiatry, Tel Aviv University Sackler School of Medicine, Tel Aviv, Israel; PPRS Research, Rouffach, France; Minerva Neurosciences, Waltham, Mass.; and the Louis and Gabi Weisfeld School of Social Work, Faculty of Social Sciences, Bar Ilan University, Ramat Gan, Israel.

Notes

Send correspondence to Dr. Davidson ([email protected]).

Funding Information

Minerva Neurosciences Inc.
This phase 2b clinical trial was funded by Minerva Neurosciences.

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