A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)
Public ClinicalTrials.gov record NCT07076407. 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-NOVA3 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
- NCT07076407
- 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
- Jul 8, 2025 (Actual)
- Primary completion
- May 2027 (Estimated)
- Completion
- Jul 2027 (Estimated)
- Last update posted
- Oct 15, 2026
2025 – 2027
United States locations
- U.S. sites
- 35
- U.S. states
- 18
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Harmonex Neuroscience Research | Dothan | Alabama | 36303 | — |
| University of Alabama at Birmingham, Huntsville Regional Medical Campus | Huntsville | Alabama | 35801 | — |
| Pillar Clinical Research | Bentonville | Arkansas | 72712 | — |
| SanRo Clinical Research Group | Bryant | Arkansas | 72022 | — |
| Clinical Innovations Inc | Bellflower | California | 90706 | — |
| Center for Neurohealth | La Jolla | California | 93037 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | — |
| California Neuroscience Research | Sherman Oaks | California | 91403 | — |
| Pacific Clinical Research Management Group | Upland | California | 91786 | — |
| Institute of Living | Hartford | Connecticut | 06106 | — |
| Gulfcoast Clinical Research Center | Fort Myers | Florida | 33912 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| Equipath Health and Research Tampa Bay, Llc | Riverview | Florida | 33578 | — |
| Delricht Research | Atlanta | Georgia | 30329 | — |
| Emory University Brain Health Center | Atlanta | Georgia | 30329 | — |
| Advanced Quality Medical Research | Orland Park | Illinois | 60462 | — |
| Smart Trials, LLC | Jefferson | Louisiana | 70121 | — |
| Pharmasite Research Inc. | Baltimore | Maryland | 21208-6605 | — |
| Adams Clinical Boston | Boston | Massachusetts | 02116 | — |
| Activmed Practices & Research, Llc - Methuen | Methuen | Massachusetts | 01844 | — |
| Adams Clinical Watertown | Watertown | Massachusetts | 02472 | — |
| Vitalix Clinical, Inc | Worcester | Massachusetts | 01608 | — |
| Psychiatric Care and Research Center | O'Fallon | Missouri | 63368 | — |
| St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri | 63304 | — |
| Lumina Clinical Research Center | Cherry Hill | New Jersey | 08002 | — |
| Princeton Medical Institute | Princeton | New Jersey | 08540 | — |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | — |
| Bioscience Research, LLC | Mount Kisco | New York | 10549 | — |
| Fieve Clinical Research, Inc. | New York | New York | 10017 | — |
| IMA Clinical Research | New York | New York | 10128 | — |
| Magnolia Clinical Research, Llc | Cary | North Carolina | 27511 | — |
| Insight Clinical Trials | Independence | Ohio | 44195 | — |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73116 | — |
| Austin Clinical Trial Partners | Austin | Texas | 78737 | — |
| Boeson Research | Provo | Utah | 84604 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07076407, 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 15, 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 NCT07076407 live on ClinicalTrials.gov.