Evaluating milsaperidone for treating major depressive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy and safety of milsaperidone as an adjunctive therapy for patients diagnosed with Major Depressive Disorder (MDD) who have not responded adequately to current antidepressant treatments. Participants will be randomly assigned to receive either milsaperidone or a placebo, with their responses monitored over the course of the trial. The study will utilize the Antidepressant Treatment Response Questionnaire to confirm inadequate response to existing therapies. The goal is to determine if milsaperidone can provide additional benefits in managing MDD symptoms.

Why it matters

Who can join: the full rules

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
* Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment

Where it's running

• Vanda Investigational Site
  Phoenix, Arizona, United States Recruiting
• Vanda Investigational Site
  Little Rock, Arkansas, United States Recruiting
• Vanda Investigational Site
  Garden Grove, California, United States Recruiting
• Vanda Investigational Site
  Orange, California, United States Recruiting
• Vanda Investigational Site
  Redlands, California, United States Recruiting
• Vanda Investigational Site
  San Jose, California, United States Recruiting

+3 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Vanda Pharmaceuticals
• Email: clinicaltrials@vandapharma.com
• Phone: 202-734-3400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.