NCT06830044RecruitingPhase 3
Evaluation of Efficacy and Safety of Milsaperidone 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
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 11 Feb 2025
- Start date
- 3 Mar 2025
- Primary completion date
- Mar 2028
- Lead sponsor
- Vanda Pharmaceuticals
- Diseases
- Depression
- NCT number
- NCT06830044
- EU CT number
- 2024-520333-68-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 500
- From 3 Mar 2025 to the primary completion date, Mar 2028
- 57 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (57)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Center Lifemed EOOD Coordinator of this site? Confirm its status | Kirdzhali | Bulgaria | Recruiting |
| Ambulatory-Group Practice For Specialized Psychiatric Help Datamed Ltd. Coordinator of this site? Confirm its status | Pleven | Bulgaria | Recruiting |
| Medical Center Mentalcare Ltd. Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| Children's Health Medical Center EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Medical Center Intermedica Ltd. Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Mental Health Center Sofia EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Multiprofile Hospital For Active Treatment - Targovishte AD Coordinator of this site? Confirm its status | Targovishte | Bulgaria | Recruiting |
| Diagnostics-Consultancy Center Mladost M Varna OOD Coordinator of this site? Confirm its status | Varna | Bulgaria | Recruiting |
| Center For Mental Health Vratsa EOOD Coordinator of this site? Confirm its status | Vratsa | Bulgaria | Recruiting |
| Medipa S R O Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| A-Shine s.r.o. Coordinator of this site? Confirm its status | Plzen 3 | Czechia | Recruiting |
| MPMeditrine s.r.o. Coordinator of this site? Confirm its status | Poruba | Czechia | Recruiting |
| INEP medical s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Praglandia s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Medical Services Prague S R O Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Clintrial s.r.o. Coordinator of this site? Confirm its status | Prague 10 | Czechia | Recruiting |
| Praxis Dr. med. Kirsten Hahn Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| FutureMeds GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| Pharmakologisches Studienzentrum Chemnitz GmbH Coordinator of this site? Confirm its status | Chemnitz | Germany | Not yet recruiting |
| Facharzt für Psychiatrie und Psychotherapie Coordinator of this site? Confirm its status | Stralsund | Germany | Not yet recruiting |
| Prywatne Gabinety Lekarskie „Promedicus” Anna Agnieszka Tomczak Coordinator of this site? Confirm its status | Białystok | Poland | Recruiting |
| Podlaskie Centrum Psychogeriatrii Coordinator of this site? Confirm its status | Bia?ystok | Poland | Recruiting |
| Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Clinic BBP Bożena Pawełczyk Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Gyncentrum Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda Coordinator of this site? Confirm its status | Suchy Las | Poland | Recruiting |
| OŚRODEK BADAŃ KLINICZNYCH CLINSANTE SPÓŁKA CYWILNA EWA GALCZAK-NOWAK, MAŁGORZATA TRZASKA Coordinator of this site? Confirm its status | Torun | Poland | Recruiting |
| Inventiva Biomedical And Research Sp. z o.o. Coordinator of this site? Confirm its status | Tuszyn | Poland | Recruiting |
| Gyncentrum Sp. z o. o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| - Coordinator of this site? Confirm its status | Bellevue | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Carmel | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Fort Myers | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Garden Grove | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Media | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Miami | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Plano | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Redlands | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Richardson | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Saint Charles | United States | Recruiting |
| - Coordinator of this site? Confirm its status | San Jose | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Snellville | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Staten Island | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Tampa | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Walnut Creek | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Witchita Falls | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.