Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder

Description

The purpose of this study is to determine the efficacy and safety of milsaperidone compared to placebo as adjunctive therapy in patients with Major Depressive Disorder

Conditions

Major Depressive Disorder (MDD)

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Study Overview

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Study Details

Study overview

The purpose of this study is to determine the efficacy and safety of milsaperidone compared to placebo as adjunctive therapy in patients with Major Depressive Disorder

A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Milsaperidone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder

Condition
Major Depressive Disorder (MDD)
Intervention / Treatment

-

Contacts and Locations

Little Rock

Vanda Investigational Site, Little Rock, Arkansas, United States, 72211

Richardson

Vanda Investigational Site, Richardson, Texas, United States, 75080

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female patient 18 to 65 years of age, inclusive;
  • * Meets DSM-5-TR criteria for MDD
  • * Currently having an inadequate response to antidepressant therapy as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ)
  • * Within the patients lifetime, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD
  • * Within 6 months of Screening, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD that is a primary diagnosis
  • * Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanda Pharmaceuticals,

Study Record Dates

2028-03