A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
Public ClinicalTrials.gov record NCT06775379. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
X-NOVA2 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adult participants diagnosed with Major Depressive Disorder (MDD)
Study identification
- NCT ID
- NCT06775379
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 450 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 74 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 20, 2024 (Actual)
- Primary completion
- Oct 2026 (Estimated)
- Completion
- Dec 2026 (Estimated)
- Last update posted
- Oct 13, 2026
2024 – 2026
United States locations
- U.S. sites
- 45
- U.S. states
- 18
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| IMA Clinical Research Phoenix | Phoenix | Arizona | 85012 | — |
| Woodland International Research Group | Little Rock | Arkansas | 72211 | — |
| Woodland Research Northwest | Rogers | Arkansas | 72758 | — |
| Irvine Clinical Research | Irvine | California | 92614 | — |
| CalNeuro Research Group, Inc. | Los Angeles | California | 90025 | — |
| Excell Research Inc. | Oceanside | California | 92056 | — |
| Atp Clinical Research | Orange | California | 92866 | — |
| Nrc Research Institute | Orange | California | 92868 | — |
| CenExel CNS-TO (Collaborative Neuroscience Research) | Torrance | California | 90504 | — |
| Sunwise Clinical Research | Walnut Creek | California | 94596 | — |
| Kinetic Clinical Research, LLC | West Covina | California | 91790 | — |
| Ct Clinical Research Associates | Cromwell | Connecticut | 06416 | — |
| CNS Clinical Research Group | Coral Springs | Florida | 33067 | — |
| NeoClinical Research | Hialeah | Florida | 33016 | — |
| Clinical Neuroscience Solutions, LLC | Jacksonville | Florida | 32256 | — |
| Accel Research Sites Lakeland | Lakeland | Florida | 33803 | — |
| Accel Research Sites - St. Petersburg-Largo | Largo | Florida | 33777 | — |
| PharmaSouth Research | Miami | Florida | 33165 | — |
| Quantum Clinical Trials | Miami Beach | Florida | 33140 | — |
| Harmony Clinical Research Inc | North Miami Beach | Florida | 33162 | — |
| Clinical Neuroscience Solutions, LLC | Orlando | Florida | 32801 | — |
| Combined Research Orlando Phase I-Iv | Orlando | Florida | 32807 | — |
| Panhandle Research and Medical Clinic | Pensacola | Florida | 32503 | — |
| Advanced Discovery Research | Atlanta | Georgia | 30318 | — |
| Synexus - Atlanta | Atlanta | Georgia | 30328 | — |
| CenExel iResearch | Decatur | Georgia | 30030 | — |
| Psych Atlanta, Pc | Marietta | Georgia | 30060 | — |
| Cenexel Iresearch - Savannah | Savannah | Georgia | 31405 | — |
| Northwest Clinical Trials Inc | Boise | Idaho | 83704 | — |
| IMA Clinical Research | Chicago | Illinois | 60634 | — |
| Boston Clinical Trials Llc | Boston | Massachusetts | 02131 | — |
| ELIXIA | Springfield | Massachusetts | 01103 | — |
| IMA Clinical Research Las Vegas | Las Vegas | Nevada | 89102 | — |
| Redbird Research | Las Vegas | Nevada | 89119 | — |
| Integrative Clinical Trials | Brooklyn | New York | 11229 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | — |
| New Hope Clinical Research | Charlotte | North Carolina | 28211 | — |
| Neuro-Behavioral Clinical Research | North Canton | Ohio | 44720 | — |
| Pahl Pharmaceutical Professionals Llc | Oklahoma City | Oklahoma | 73112 | — |
| Lehigh Center For Clinical Research | Allentown | Pennsylvania | 18103 | — |
| Adams Clinical - Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Clinical Neuroscience Solutions, LLC | Memphis | Tennessee | 38119 | — |
| Delricht Research - Plano | Plano | Texas | 75024 | — |
| Grayline Research Center | Wichita Falls | Texas | 76309 | — |
| Core Clinical Research | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06775379, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06775379 live on ClinicalTrials.gov.