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Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
NCT06830044 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06830044
The ClinicalTrials.gov registry entry for NCT06830044 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanda Pharmaceuticals, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06830044 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06830044?
The interventions under investigation include: Placebo (DRUG), Milsaperidone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06830044?
This trial is sponsored by Vanda Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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