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)
Study identification
- NCT ID
- NCT07172516
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Xenon Pharmaceuticals Inc.
- Industry
- Enrollment
- 400 participants
Conditions and interventions
Interventions
- Azetukalner Drug
- Placebo Drug
Drug
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 7, 2025
- Primary completion
- May 31, 2028
- Completion
- Jul 31, 2028
- Last update posted
- May 4, 2026
2025 – 2028
United States locations
- U.S. sites
- 28
- U.S. states
- 15
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Noble Clinical Research | Tucson | Arizona | 85704 | Recruiting |
| Woodland International Research Group | Little Rock | Arkansas | 72211 | Recruiting |
| Woodland Research Northwest | Rogers | Arkansas | 72758 | Recruiting |
| Clinical Innovations Inc | Bellflower | California | 90706 | Recruiting |
| ProScience Research Group | Culver City | California | 90230 | Recruiting |
| ATP Clinical Research | Orange | California | 92866 | Recruiting |
| NRC Research Institute | Orange | California | 92868 | Recruiting |
| Clinical Innovations Inc | Riverside | California | 92506 | Recruiting |
| PharmaSouth Research, LLC | Coral Gables | Florida | 33146 | Recruiting |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | Recruiting |
| Central Miami Medical Institute | Miami | Florida | 33125 | Recruiting |
| Clinical Neuroscience Solutions, Inc | Orlando | Florida | 32801 | Recruiting |
| Synexus Clinical Research, Inc. | Atlanta | Georgia | 30328 | Recruiting |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | Recruiting |
| CenExel iResearch | Decatur | Georgia | 30030 | Recruiting |
| Denali Health Atlanta, LLC | Stone Mountain | Georgia | 30083 | Recruiting |
| Advanced Quality Medical Research | Orland Park | Illinois | 60462 | Recruiting |
| Psychiatric Care and Research Center | O'Fallon | Missouri | 63368 | Recruiting |
| Redbird Clinical Research, LLC | Las Vegas | Nevada | 89119 | Recruiting |
| Lumina Clinical Research Center | Cherry Hill | New Jersey | 08002 | Recruiting |
| Integrative Clinical Trials LLC | Brooklyn | New York | 11229 | Recruiting |
| Neurobehavioral Research Inc | Cedarhurst | New York | 11516 | Recruiting |
| DelRicht Research | Charlotte | North Carolina | 28210 | Recruiting |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18103 | Recruiting |
| Clinical Neuroscience Solutions, Inc | Memphis | Tennessee | 38119 | Recruiting |
| Elevate Synapsis, LLC | Atascocita | Texas | 77346 | Recruiting |
| Grayline Research Center | Wichita Falls | Texas | 76309 | Recruiting |
| Eastside Therapeutics Resources, INC dba Core Clinical Research | Everett | Washington | 98201 | Recruiting |
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 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 May 4, 2026 · Synced May 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07172516 live on ClinicalTrials.gov.