Trial intelligence / Profile preview

MIN-117 in Major Depressive Disorder

NCT03446846Phase 2

Key facts

Status
Completed
Start
Mar 2018
Primary completion
Nov 2019
Countries
7
Modality
Multivalent & Scaffold-Based Small Molecules, Classical Binding Small Molecules
Drugs
min-117
Conditions
major depressive disorder (MDD)
01

Overview

Phase 2, randomised, double-blind trial of min-117 in major depressive disorder (MDD) (3 arms), sponsored by Minerva Neurosciences, Inc. Primary endpoint: Montgomery-Asberg Depression Rating Scale Total Score at 6 weeks. Started Mar 2018; status: completed.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • 5.0 mg MIN-117

    MIN-117 5.0 mg orally daily

  • 2.5 mg MIN-117

    MIN-117 2.5 mg orally daily

  • Placebo

    Placebo orally daily

03

Who it enrols

Adults 18-65 with moderate to severe MDD with anxious distress, history of at least one previous episode, and inadequate response to prior antidepressant treatment.

04

Endpoints

Primary

  • Montgomery-Asberg Depression Rating Scale Total Score

Secondary

  • Hamilton Anxiety Scale

  • Clinical Global Impression of Severity Scale

  • Clinical Global Impression of Improvement Scale

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