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Study identifier: NCT06830044 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder

Condition: Major Depressive Disorder (MDD)  ·  Sponsor: Vanda Pharmaceuticals

PhasePhase 3
Planned participants500
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where38 locations · 4 countries

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

Vanda Pharmaceuticals  ·  202-734-3400  ·  clinicaltrials@vandapharma.com

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (38)

Vanda Investigational SitePhoenix, Arizona, United StatesRecruiting
Vanda Investigational SiteLittle Rock, Arkansas, United StatesRecruiting
Vanda Investigational SiteGarden Grove, California, United StatesRecruiting
Vanda Investigational SiteLemon Grove, California, United StatesRecruiting
Vanda Investigational SiteOrange, California, United StatesRecruiting
Vanda Investigational SiteSan Jose, California, United StatesRecruiting
Vanda Investigational SiteWalnut Creek, California, United StatesRecruiting
Vanda Investigational SiteColorado Springs, Colorado, United StatesRecruiting
Vanda Investigational SiteFort Myers, Florida, United StatesRecruiting
Vanda Investigational SiteMiami, Florida, United StatesActive Not Recruiting
Vanda Investigational SiteMiami, Florida, United StatesRecruiting
Vanda Investigational SiteTampa, Florida, United StatesActive Not Recruiting

+ 26 more locations — full list on the registry record.

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