NCT07172516 A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
| NCT ID | NCT07172516 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Xenon Pharmaceuticals Inc. |
| Condition | Bipolar Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-08-08 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2025-08-08 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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). * Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 12 months. * Participant has self-injurious behavior without intent to die in the 12 months prior to screening. * Participant has used antidepressants, mood stabilizers, anticonvulsants, antipsychotics, or other prohibited medications within the 1 week or within a period less than 5 times the drug's half-life, whichever is longer prior to randomization. * Participants with medical conditions that may interfere with the purpose or conduct of the study. * Participant is pregnant, breastfeeding, or planning to become pregnant.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07172516 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying Bipolar Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07172516 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT07172516 currently recruiting?
Yes, NCT07172516 is actively recruiting participants. Contact the research team at XenonCares@xenon-pharma.com for enrollment information.
Where is the NCT07172516 trial being conducted?
This trial is being conducted at Tucson, United States, Little Rock, United States, Rogers, United States, Bellflower, United States and 11 additional locations.
Who is sponsoring the NCT07172516 clinical trial?
NCT07172516 is sponsored by Xenon Pharmaceuticals Inc.. The trial plans to enroll 400 participants.
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