Tests milsaperidone added to usual treatment for major depressive disorder
Tests milsaperidone or placebo added to usual care in adults with depression.
Plain-language title generated from the registry record
Registry title: Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
Key facts
- Where
- Bia?ystok, Białystok, Bydgoszcz, Gdansk, Katowice, Suchy Las, Torun, Tuszyn, and Warsaw, PolandSee the 10 sites
- Phase
- Phase 3
AI summary: who the study is looking for
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
Read by machine on 9 November 2026.
Could this be for you?
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?
Source: NCT06830044, who can take part
Where in Poland
- Podlaskie Centrum PsychogeriatriiBia?ystok, PolandTaking people
- Prywatne Gabinety Lekarskie „Promedicus” Anna Agnieszka TomczakBiałystok, PolandTaking people
- Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata TrzaskaBydgoszcz, PolandTaking people
- Uniwersyteckie Centrum KliniczneGdansk, PolandTaking people
- Clinic BBP Bożena PawełczykKatowice, PolandTaking people
- Gyncentrum Sp. z o.o.Katowice, PolandTaking people
- Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger MolendaSuchy Las, PolandTaking people
- OŚRODEK BADAŃ KLINICZNYCH CLINSANTE SPÓŁKA CYWILNA EWA GALCZAK-NOWAK, MAŁGORZATA TRZASKATorun, PolandTaking people
- Inventiva Biomedical And Research Sp. z o.o.Tuszyn, PolandTaking people
- Gyncentrum Sp. z o. o.Warsaw, PolandTaking people
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?
Trial details
- Who runs it
- Vanda Pharmaceuticals
- Trial code
- NCT06830044EU 2024-520333-68-00
- Record updated
- 24 September 2026
- Original description
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 DisorderRead full original descriptionShow less
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
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
Inclusion: 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: 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.