NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

NCT07172516

RecruitingPhase 3

Sponsor: Xenon Pharmaceuticals Inc.

Conditions: Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder

Interventions: Azetukalner, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 74 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (28)

Tucson, Arizona, United States
Little Rock, Arkansas, United States
Rogers, Arkansas, United States
Bellflower, California, United States
Culver City, California, United States
Orange, California, United States
Orange, California, United States
Riverside, California, United States
Coral Gables, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Stone Mountain, Georgia, United States
Orland Park, Illinois, United States
O'Fallon, Missouri, United States
Las Vegas, Nevada, United States
Cherry Hill, New Jersey, United States
Brooklyn, New York, United States
Cedarhurst, New York, United States
Charlotte, North Carolina, United States
Allentown, Pennsylvania, United States
Memphis, Tennessee, United States
Atascocita, Texas, United States
Wichita Falls, Texas, United States
Everett, Washington, United States