A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
← catalyst calendarNCT07172516 · readout ≤ 680 d
Sponsored by Xenon Pharmaceuticals Inc. (industry) · XENE — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
400estimated
Sites
28
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-08-08 | actual | When the study began enrolling |
| Primary completion | Jun 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2025-09-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Bipolar Disorder
- Bipolar Depression
- Bipolar I Disorder
- Bipolar II Disorder
Interventions
- Drug: Azetukalner — also filed as XEN1101
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFChange from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.
measured Baseline to Week 6
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