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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Vanda Pharmaceuticals
Study ID
NCT06830044
Phase
PHASE3
Status
Recruiting
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Conditions

  • Major Depressive Disorder (MDD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Milsaperidone — DRUG
    Oral milsaperidone
  • Placebo — DRUG
    Oral placebo

Study Details

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

Key Dates

Start date
Mar 3, 2025
Status verified
Feb 2025
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Milsaperidone
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 6 weeks ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
Vanda Investigational SitePhoenixArizona85012
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteLittle RockArkansas72211
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteGarden GroveCalifornia92845
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteLemon GroveCalifornia91945
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteOrangeCalifornia92868
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteSan JoseCalifornia95124
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteWalnut CreekCalifornia94596
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteColorado SpringsColorado80910
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteFort MyersFlorida33912
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteMiamiFlorida33135-
Vanda Investigational SiteMiamiFlorida33173
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteTampaFlorida33614-
Vanda Investigational SiteChicagoIllinois60634
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteSaint CharlesMissouri63304
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteLas VegasNevada89119
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteNew YorkNew York10035
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteStaten IslandNew York10314
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteMediaPennsylvania19063
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteRichardsonTexas75080
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteWitchita FallsTexas76309
Vanda Pharmaceuticals Inc.
202-734-3400
Vanda Investigational SiteBellevueWashington98007
Vanda Pharmaceuticals Inc.
202-734-3400

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Vanda Investigational Site· Phoenix, AZVanda Investigational Site· Little Rock, ARVanda Investigational Site· Garden Grove, CAVanda Investigational Site· Lemon Grove, CAVanda Investigational Site· Orange, CAVanda Investigational Site· San Jose, CA

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