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Compares treatment options for Bipolar Disorder
Official title A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
ClinicalTrials.gov ID: NCT07172516
What this study is testing
What is Azetukalner?
Azetukalner is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for bipolar disorder.
Also referred to as XEN1101.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- 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...
- Current MDE must has a duration of ≥4 weeks and ≤12 months. Key
You likely can't join if
- Participant has any type of major depressive disorder (MDD) diagnosis, including MDD with psychotic features, MDD with catatonia, MDD with seasonal...
- 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.
See the full eligibility 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...
- Current MDE must has a duration of ≥4 weeks and ≤12 months. Key
- 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...
- 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...
- Participants with medical conditions that may interfere with the purpose or conduct of the study.
- Participant is pregnant, breastfeeding, or planning to become pregnant.
The study team makes the final eligibility decision.
Where it's taking place
- 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
- 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
- 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
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.