Taking people in BulgariaPhase 3
Tests milsaperidone added to usual treatment for major depressive disorder
Tests milsaperidone or placebo added to usual care in adults with depression.
Key facts
- Who runs it
- Vanda Pharmaceuticals
- Where
- Kirdzhali, Pleven, Plovdiv, Sofia, Targovishte, Varna, and Vratsa, BulgariaSee the 9 sitesAlso in 4 other countries, 48 sites
- Trial code
- Registry title
- Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 500 people, planned
- Started
- 3 Mar 2025
- Expected to end
- Mar 2028
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Milsaperidone
- Placebo
- Record updated
- 24 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 65 with major depression whose current antidepressant is not working well enough. Milsaperidone or placebo is added to the antidepressant.
- Age
- 18 to 65 years, inclusive
- Sex
- Men and women can join
- Disease stage
- Major depressive disorder (MDD) by DSM-5-TR criteria, with an inadequate response to current antidepressant treatment, confirmed by the investigator using the ATRQ questionnaire
- Earlier treatment
- Must currently be on antidepressant therapy that is not working well enough
Main reasons for not taking part
- Any other psychiatric diagnosis than MDD during their lifetime
- Any other psychiatric diagnosis than MDD within 6 months of screening
- Any other psychiatric condition that was the main focus of treatment within 12 months of screening
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in Bulgaria
Also in 4 other countries, 48 sites
- Medical Center Lifemed EOODKirdzhali, BulgariaTaking people
- Ambulatory-Group Practice For Specialized Psychiatric Help Datamed Ltd.Pleven, BulgariaTaking people
- Medical Center Mentalcare Ltd.Plovdiv, BulgariaTaking people
- Children's Health Medical Center EOODSofia, BulgariaTaking people
- Medical Center Intermedica Ltd.Sofia, BulgariaTaking people
- Mental Health Center Sofia EOODSofia, BulgariaTaking people
- Multiprofile Hospital For Active Treatment - Targovishte ADTargovishte, BulgariaTaking people
- Diagnostics-Consultancy Center Mladost M Varna OODVarna, BulgariaTaking people
- Center For Mental Health Vratsa EOODVratsa, BulgariaTaking people
About the trial
What the trial wants to find out
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
The 2 groups in the trial
- MilsaperidoneTreatment being tested
- PlaceboPlacebo, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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
- Plain-language title
- Tests milsaperidone added to usual treatment for major depressive disorderGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06830044, who can take part
- Record updated
- 24 September 2026