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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

Full criteria on ClinicalTrials.gov

Sites (57)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical Center Lifemed EOOD
Coordinator of this site? Confirm its status
KirdzhaliBulgariaRecruiting
Ambulatory-Group Practice For Specialized Psychiatric Help Datamed Ltd.
Coordinator of this site? Confirm its status
PlevenBulgariaRecruiting
Medical Center Mentalcare Ltd.
Coordinator of this site? Confirm its status
PlovdivBulgariaRecruiting
Children's Health Medical Center EOOD
Coordinator of this site? Confirm its status
SofiaBulgariaRecruiting
Medical Center Intermedica Ltd.
Coordinator of this site? Confirm its status
SofiaBulgariaRecruiting
Mental Health Center Sofia EOOD
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SofiaBulgariaRecruiting
Multiprofile Hospital For Active Treatment - Targovishte AD
Coordinator of this site? Confirm its status
TargovishteBulgariaRecruiting
Diagnostics-Consultancy Center Mladost M Varna OOD
Coordinator of this site? Confirm its status
VarnaBulgariaRecruiting
Center For Mental Health Vratsa EOOD
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VratsaBulgariaRecruiting
Medipa S R O
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BrnoCzechiaRecruiting
A-Shine s.r.o.
Coordinator of this site? Confirm its status
Plzen 3CzechiaRecruiting
MPMeditrine s.r.o.
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PorubaCzechiaRecruiting
INEP medical s.r.o.
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PragueCzechiaRecruiting
Praglandia s.r.o.
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PragueCzechiaRecruiting
Medical Services Prague S R O
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PragueCzechiaRecruiting
Clintrial s.r.o.
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Prague 10CzechiaRecruiting
Praxis Dr. med. Kirsten Hahn
Coordinator of this site? Confirm its status
BerlinGermanyNot yet recruiting
FutureMeds GmbH
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BerlinGermanyNot yet recruiting
Pharmakologisches Studienzentrum Chemnitz GmbH
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ChemnitzGermanyNot yet recruiting
Facharzt für Psychiatrie und Psychotherapie
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StralsundGermanyNot yet recruiting
Prywatne Gabinety Lekarskie „Promedicus” Anna Agnieszka Tomczak
Coordinator of this site? Confirm its status
BiałystokPolandRecruiting
Podlaskie Centrum Psychogeriatrii
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Bia?ystokPolandRecruiting
Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska
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BydgoszczPolandRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Clinic BBP Bożena Pawełczyk
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KatowicePolandRecruiting
Gyncentrum Sp. z o.o.
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KatowicePolandRecruiting
Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
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Suchy LasPolandRecruiting
OŚRODEK BADAŃ KLINICZNYCH CLINSANTE SPÓŁKA CYWILNA EWA GALCZAK-NOWAK, MAŁGORZATA TRZASKA
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TorunPolandRecruiting
Inventiva Biomedical And Research Sp. z o.o.
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TuszynPolandRecruiting
Gyncentrum Sp. z o. o.
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WarsawPolandRecruiting
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BellevueUnited StatesRecruiting
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BostonUnited StatesRecruiting
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CarmelUnited StatesRecruiting
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CharlotteUnited StatesRecruiting
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ChicagoUnited StatesRecruiting
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CincinnatiUnited StatesRecruiting
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Colorado SpringsUnited StatesRecruiting
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Fort MyersUnited StatesRecruiting
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Garden GroveUnited StatesRecruiting
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HoustonUnited StatesRecruiting
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Las VegasUnited StatesRecruiting
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Little RockUnited StatesRecruiting
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MediaUnited StatesActive, not recruiting
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MiamiUnited StatesActive, not recruiting
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New YorkUnited StatesRecruiting
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OrangeUnited StatesRecruiting
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PhoenixUnited StatesRecruiting
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PlanoUnited StatesRecruiting
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RedlandsUnited StatesRecruiting
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RichardsonUnited StatesRecruiting
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Saint CharlesUnited StatesRecruiting
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San JoseUnited StatesRecruiting
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SnellvilleUnited StatesRecruiting
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Staten IslandUnited StatesRecruiting
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TampaUnited StatesActive, not recruiting
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Coordinator of this site? Confirm its status
Walnut CreekUnited StatesRecruiting
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Witchita FallsUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.