Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
Recruiting · NCT06830044 · Interventional (participants receive a specific treatment) · Lead sponsor: Vanda Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
MilsaperidonePlacebo
What this trial is about
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
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 is running
38 locations listed across 12 US states.
- Vanda Investigational Site - Phoenix, Arizona, United States
- Vanda Investigational Site - Little Rock, Arkansas, United States
- Vanda Investigational Site - Garden Grove, California, United States
- Vanda Investigational Site - Lemon Grove, California, United States
- Vanda Investigational Site - Orange, California, United States
- Vanda Investigational Site - San Jose, California, United States
- Vanda Investigational Site - Walnut Creek, California, United States
- Vanda Investigational Site - Colorado Springs, Colorado, United States
- Vanda Investigational Site - Fort Myers, Florida, United States
- Vanda Investigational Site - Miami, Florida, United States
- Vanda Investigational Site - Miami, Florida, United States
- Vanda Investigational Site - Tampa, Florida, United States
- Vanda Investigational Site - Chicago, Illinois, United States
- Vanda Investigational Site - Saint Charles, Missouri, United States
- Vanda Investigational Site - Las Vegas, Nevada, United States
- Vanda Investigational Site - New York, New York, United States
- Vanda Investigational Site - Staten Island, New York, United States
- Vanda Investigational Site - Media, Pennsylvania, United States
- Vanda Investigational Site - Richardson, Texas, United States
- Vanda Investigational Site - Witchita Falls, Texas, United States
- Vanda Investigational Site - Bellevue, Washington, United States
- Vanda Investigational Site - Bialystok, Poland
- Vanda Investigational Site - Brno, Czechia
- Vanda Investigational Site - Bydgoszcz, Poland
- Vanda Investigational Site - Gdansk, Poland
- Vanda Investigational Site - Katowice, Poland
- Vanda Investigational Site - Katowice, Poland
- Vanda Investigational Site - Pilsen, Czechia
- Vanda Investigational Site - Poruba, Czechia
- Vanda Investigational Site - Prague, Czechia
- Vanda Investigational Site - Prague, Czechia
- Vanda Investigational Site - Prague, Czechia
- Vanda Investigational Site - Sofia, Bulgaria
- Vanda Investigational Site - Sofia, Bulgaria
- Vanda Investigational Site - Sofia, Bulgaria
- Vanda Investigational Site - Suchy Las, Poland
- Vanda Investigational Site - Targovishte, Bulgaria
- Vanda Investigational Site - Varna, Bulgaria