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NCT06830044 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
A Phase 3 study of Major Depressive Disorder (MDD), sponsored by Vanda Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT06830044: Recruiting Phase 3 study of Major Depressive Disorder (MDD), sponsored by Vanda Pharmaceuticals.
NCT06830044 is a Phase 3 study of Major Depressive Disorder (MDD) that is actively recruiting participants, run by Vanda Pharmaceuticals. The registered enrollment target is 500 participants, above the 136-participant average among 22 other Major Depressive Disorder (MDD) trials with a reported enrollment target (268% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06830044, a Phase 3 study of Major Depressive Disorder (MDD), is actively recruiting participants, sponsored by Vanda Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study Summary
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
Primary Outcome
The MADRS is a clinician-rated 10 item scale. Individual item scores are summed for a total possible score of 0 to 60 with a higher score indicating increased severity of depressive symptoms.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Milsaperidone
Study Locations (20)
California
- Vanda Investigational Site - Garden Grove
- Vanda Investigational Site - Lemon Grove
- Vanda Investigational Site - Orange
- Vanda Investigational Site - San Jose
- Vanda Investigational Site - Walnut Creek
Florida
- Vanda Investigational Site - Fort Myers
- Vanda Investigational Site - Miami
- Vanda Investigational Site - Miami
- Vanda Investigational Site - Tampa
New York
- Vanda Investigational Site - New York
- Vanda Investigational Site - Staten Island
Texas
- Vanda Investigational Site - Richardson
- Vanda Investigational Site - Witchita Falls
Arizona
- Vanda Investigational Site - Phoenix
Arkansas
- Vanda Investigational Site - Little Rock
Colorado
- Vanda Investigational Site - Colorado Springs
Illinois
- Vanda Investigational Site - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2025-03-03 |
| Est. Completion | 2028-03 |
| Phase | Phase 3 |
What NCT06830044 shows while recruiting
NCT06830044 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 136-participant average among 22 other Major Depressive Disorder (MDD) trials with a reported enrollment target (268% higher).
The record links to 1 condition, with Major Depressive Disorder (MDD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06830044 names 20 study sites across 11 states, led by California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT06830044 about?
NCT06830044 is a clinical study titled "Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in 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
What is the current status of trial NCT06830044?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2025-03-03. Estimated completion is 2028-03.
What conditions does trial NCT06830044 study?
This clinical trial studies the following conditions: Major Depressive Disorder (MDD).
What interventions are being tested in trial NCT06830044?
The interventions under investigation include: Placebo (DRUG), Milsaperidone (DRUG).
Who is sponsoring clinical trial NCT06830044?
This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06830044 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder (MDD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06830044's enrollment target sits among peer trials
500 1st of 22 higher than 22 of 22 other Major Depressive Disorder (MDD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder (MDD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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