A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I… (NCT07172516) | Clinical Trial Compass
RecruitingPhase 3
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
United States400 participantsStarted 2025-08-08
Plain-language 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).
Who can participate
Age range
18 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Adults ≥18 and ≤74 years of age who experienced their first major depressive episode (MDE) prior to 50 years of age.
* Body Mass Index (BMI) ≥18 kg/m2 and ≤40 kg/m2.
* Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder and is currently in a MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI).
* Current MDE must has a duration of ≥4 weeks and ≤12 months.
Key Exclusion Criteria:
* Participant has any type of major depressive disorder (MDD) diagnosis, including MDD with psychotic features, MDD with catatonia, MDD with seasonal pattern, or postpartum depression.
* Participant has any nonbipolar psychiatric diagnosis.
* Participant has a substance use disorder (excluding tobacco) within the 6 months prior to screening visit.
* Participant has a symptomatic eating disorder within the 12 months prior to screening visit.
* Participant has a Young Mania Rating Scale (YMRS) score \>12 points at screening visit or randomization.
* Participant has been hospitalized for mania within the 30 days prior to screening visit.
* Participant is considered treatment-resistant in the current bipolar depressive episode, defined as having treatment resistance (no remission) to ≥2 different medications approved by the regional regulatory authority at an adequate dose (per regulatory approved label) and for an adequate duration (at least 6 weeks).
* Particip…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.