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NCT07172516 · ClinicalTrials.gov registry record · Phase 3
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
A Phase 3 study of Bipolar Disorder and Bipolar Depression, sponsored by Xenon Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT07172516: Recruiting Phase 3 study of Bipolar Disorder and Bipolar Depression, sponsored by Xenon Pharmaceuticals.
NCT07172516 is a Phase 3 study of Bipolar Disorder and Bipolar Depression that is actively recruiting participants, run by Xenon Pharmaceuticals. The registered enrollment target is 400 participants, above the 330-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (21% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07172516, a Phase 3 study of Bipolar Disorder and Bipolar Depression, is actively recruiting participants, sponsored by Xenon Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Azetukalner
Study Locations (20)
California
- Clinical Innovations Inc - Bellflower
- ProScience Research Group - Culver City
- ATP Clinical Research - Orange
- NRC Research Institute - Orange
- Clinical Innovations Inc - Riverside
Florida
- PharmaSouth Research, LLC - Coral Gables
- Clinical Neuroscience Solutions, Inc. - Jacksonville
- Central Miami Medical Institute - Miami
- Clinical Neuroscience Solutions, Inc - Orlando
Georgia
- Synexus Clinical Research, Inc. - Atlanta
- Atlanta Center for Medical Research - Atlanta
- CenExel iResearch - Decatur
- Denali Health Atlanta, LLC - Stone Mountain
Arkansas
- Woodland International Research Group - Little Rock
- Woodland Research Northwest - Rogers
New York
- Integrative Clinical Trials LLC - Brooklyn
- Neurobehavioral Research Inc - Cedarhurst
Arizona
- Noble Clinical Research - Tucson
Missouri
- Psychiatric Care and Research Center - O'Fallon
New Jersey
- Lumina Clinical Research Center - Cherry Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2025-08-08 |
| Est. Completion | 2028-08 |
| Phase | Phase 3 |
What NCT07172516 shows while recruiting
NCT07172516 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 330-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (21% higher).
The record links to 4 conditions, with Bipolar Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07172516 names 20 study sites across 8 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT07172516 about?
NCT07172516 is a clinical study titled "A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)". 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).
What is the current status of trial NCT07172516?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2025-08-08. Estimated completion is 2028-08.
What conditions does trial NCT07172516 study?
This clinical trial studies the following conditions: Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder.
What interventions are being tested in trial NCT07172516?
The interventions under investigation include: Placebo (DRUG), Azetukalner (DRUG).
Who is sponsoring clinical trial NCT07172516?
This trial is sponsored by Xenon Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07172516 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07172516's enrollment target sits among peer trials
400 17th of 162 higher than 145 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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