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

Launched by VANDA PHARMACEUTICALS · Feb 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called milsaperidone to see how well it works and how safe it is for people who are struggling with Major Depressive Disorder (MDD). Milsaperidone will be compared to a placebo, which is a treatment that looks like the real medication but doesn’t contain any active ingredients. The goal is to find out if milsaperidone can help improve the symptoms of depression in patients who are not getting enough relief from their current antidepressant treatment.

To participate in the study, you need to be between 18 and 65 years old and diagnosed with MDD according to specific criteria. You should also be experiencing limited improvement from your current antidepressant. However, if you have a different psychiatric diagnosis or have recently been treated for another mental health condition, you may not be eligible for this trial. Participants can expect to receive either milsaperidone or the placebo during the study, and they will work closely with the study team to monitor their progress and any side effects. This trial is important as it could help find new treatment options for those who are struggling with depression.

Gender

ALL

Eligibility criteria

• Inclusion 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)
• Exclusion Criteria:
• • 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