A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Recruiting · NCT07172516 · Interventional (participants receive a specific treatment) · Lead sponsor: Xenon Pharmaceuticals Inc.
View the official record on ClinicalTrials.gov →Interventions studied
AzetukalnerPlacebo
What this trial is about
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 take part
Age range
18 Years to 74 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
44 locations listed across 15 US states.
- Noble Clinical Research - Tucson, Arizona, United States
- Woodland International Research Group - Little Rock, Arkansas, United States
- Woodland Research Northwest - Rogers, Arkansas, United States
- Clinical Innovations Inc - Bellflower, California, United States
- ProScience Research Group - Culver City, California, United States
- ATP Clinical Research - Orange, California, United States
- NRC Research Institute - Orange, California, United States
- Clinical Innovations Inc - Riverside, California, United States
- Sunwise Clinical Research - Walnut Creek, California, United States
- PharmaSouth Research, LLC - Coral Gables, Florida, United States
- Sarkis Clinical Research - Gainesville, Florida, United States
- Clinical Neuroscience Solutions, LLC - Jacksonville, Florida, United States
- Central Miami Medical Institute - Miami, Florida, United States
- Clinical Neuroscience Solutions, LLC - Orlando, Florida, United States
- Synexus Clinical Research, Inc. - Atlanta, Georgia, United States
- Atlanta Center for Medical Research - Atlanta, Georgia, United States
- CenExel iResearch - Decatur, Georgia, United States
- Denali Health Atlanta, LLC - Stone Mountain, Georgia, United States
- Revival Research Institute - Elgin, Illinois, United States
- Advanced Quality Medical Research - Orland Park, Illinois, United States
- Psychiatric Care and Research Center - O'Fallon, Missouri, United States
- Redbird Clinical Research, LLC - Las Vegas, Nevada, United States
- Lumina Clinical Research Center - Cherry Hill, New Jersey, United States
- Bio Behavioral Health - Toms River, New Jersey, United States
- Integrative Clinical Trials LLC - Brooklyn, New York, United States
- Neurobehavioral Research Inc - Cedarhurst, New York, United States
- Richmond Behavioral Associates - Staten Island, New York, United States
- DelRicht Research - Charlotte, North Carolina, United States
- Lehigh Center for Clinical Research - Allentown, Pennsylvania, United States
- Clinical Neuroscience Solutions, LLC - Memphis, Tennessee, United States
- Elevate Synapsis, LLC - Atascocita, Texas, United States
- Memorial Hermann Village - Houston, Texas, United States
- Grayline Research Center - Wichita Falls, Texas, United States
- Core Clinical Research - Everett, Washington, United States
- Universitätsklinikum Carl Gustav Carus, TU Dresden - Klinik und Poliklinik für Psychiatrie - Dresden, Germany
- Multiprofile Hospital for Active Treatment "Dr. Hristo Stambolski" - Kazanlak, Bulgaria
- State Psychiatric Hospital Lovech - Lovech, Bulgaria
- Instituto de Psiquiatría y Salud Mental. Hospital General Universitario Gregorio Marañón - Madrid, Spain
- University Hospital Münster - Münster, Germany
- Hospital Universitari Son Espases - Palma de Mallorca, Spain
- HU. Álvaro Cunqueiro - Pontevedra, Spain
- Saint Naum Medical Center - Sofia, Bulgaria
- Diagnostic and Consulting Center XI Sofia - Sofia, Bulgaria
- Diagnostics-Consultative Center Mladost M Varna OOD - Varna, Bulgaria