A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Public ClinicalTrials.gov record NCT07172516. 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 the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).
Study identification
- NCT ID
- NCT07172516
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 400 participants
Conditions and interventions
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
- Aug 8, 2025 (Actual)
- Primary completion
- Jun 2028 (Estimated)
- Completion
- Aug 2028 (Estimated)
- Last update posted
- Oct 13, 2026
2025 – 2028
United States locations
- U.S. sites
- 34
- U.S. states
- 15
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Noble Clinical Research | Tucson | Arizona | 85704 | — |
| Woodland International Research Group | Little Rock | Arkansas | 72211 | — |
| Woodland Research Northwest | Rogers | Arkansas | 72758 | — |
| Clinical Innovations Inc | Bellflower | California | 90706 | — |
| ProScience Research Group | Culver City | California | 90230 | — |
| ATP Clinical Research | Orange | California | 92866 | — |
| NRC Research Institute | Orange | California | 92868 | — |
| Clinical Innovations Inc | Riverside | California | 92506 | — |
| Sunwise Clinical Research | Walnut Creek | California | 94596 | — |
| PharmaSouth Research, LLC | Coral Gables | Florida | 33146 | — |
| Sarkis Clinical Research | Gainesville | Florida | 32607 | — |
| Clinical Neuroscience Solutions, LLC | Jacksonville | Florida | 32256 | — |
| Central Miami Medical Institute | Miami | Florida | 33125 | — |
| Clinical Neuroscience Solutions, LLC | Orlando | Florida | 32801 | — |
| Synexus Clinical Research, Inc. | Atlanta | Georgia | 30328 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| CenExel iResearch | Decatur | Georgia | 30030 | — |
| Denali Health Atlanta, LLC | Stone Mountain | Georgia | 30083 | — |
| Revival Research Institute | Elgin | Illinois | 60123 | — |
| Advanced Quality Medical Research | Orland Park | Illinois | 60462 | — |
| Psychiatric Care and Research Center | O'Fallon | Missouri | 63368 | — |
| Redbird Clinical Research, LLC | Las Vegas | Nevada | 89119 | — |
| Lumina Clinical Research Center | Cherry Hill | New Jersey | 08002 | — |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | — |
| Integrative Clinical Trials LLC | Brooklyn | New York | 11229 | — |
| Neurobehavioral Research Inc | Cedarhurst | New York | 11516 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | — |
| DelRicht Research | Charlotte | North Carolina | 28210 | — |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18103 | — |
| Clinical Neuroscience Solutions, LLC | Memphis | Tennessee | 38119 | — |
| Elevate Synapsis, LLC | Atascocita | Texas | 77346 | — |
| Memorial Hermann Village | Houston | Texas | 77043 | — |
| 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07172516, 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 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07172516 live on ClinicalTrials.gov.