RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2025-03-03
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06830044

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female patient 18 to 65 years of age, inclusive;
  2. * Meets DSM-5-TR criteria for MDD
  3. * Currently having an inadequate response to antidepressant therapy as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ)
  1. * Within the patients lifetime, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD
  2. * Within 6 months of Screening, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD that is a primary diagnosis
  3. * Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment

Contacts and Locations

Study Contact

Vanda Pharmaceuticals
CONTACT
202-734-3400
clinicaltrials@vandapharma.com

Study Locations (Sites)

Vanda Investigational Site
Little Rock, Arkansas, 72211
United States
Vanda Investigational Site
Richardson, Texas, 75080
United States

Collaborators and Investigators

Sponsor: Vanda Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-03
Study Completion Date2028-03

Study Record Updates

Study Start Date2025-03-03
Study Completion Date2028-03

Terms related to this study

Additional Relevant MeSH Terms

  • Major Depressive Disorder (MDD)