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)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522775-29-00

Enrollment

Registered

2026-03-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive episodes associated with Bipolar disorder I or II (Bipolar Depression)

Brief summary

Change from baseline in the MADRS total score at Week 6.

Detailed description

Change from baseline in the CGI-S score at Week 6., Change from baseline in the MADRS total score at Week 1., Change from baseline in the SHAPS total score at Week 6.

Interventions

DRUGPlacebo

DRUGXPF-010

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in the MADRS total score at Week 6.	—

Secondary

Measure	Time frame
Change from baseline in the CGI-S score at Week 6., Change from baseline in the MADRS total score at Week 1., Change from baseline in the SHAPS total score at Week 6.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 11, 2026