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Compares treatment options for Major Depressive Disorder
Official title A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
ClinicalTrials.gov ID: NCT06775379
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 major depressive 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-NOVA2 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adult participants diagnosed with Major Depressive Disorder (MDD)
- 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 and experienced their first major depressive episode (MDE) prior to 50 years of age
- Body Mass Index (BMI) ≤40 kg/m2
- Meets the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) criteria for current major depressive disorder...
- Participant's current MDE has a duration of ≥6 weeks and ≤24 months. Key
You likely can't join if
- Participant has a primary diagnosis of a mood disorder other than MDD.
- Participant has a history of any of the following: MDD with psychotic or catatonic features; MDD with mixed features; Bipolar I or II disorder...
- Participant has a current diagnosis of any of the following: MDD with seasonal pattern; Depression with peripartum or perimenopausal onset; Post...
- Participant has a substance (excluding tobacco) or alcohol use disorder within the 12 months prior to screening.
- Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 2 years, or \>1...
- Participant has a history of non-suicidal self-harm behavior in the 12 months prior to screening.
See the full eligibility criteria
- Adults ≥18 and ≤74 years of age and experienced their first major depressive episode (MDE) prior to 50 years of age
- Body Mass Index (BMI) ≤40 kg/m2
- Meets the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) criteria for current major depressive disorder and is currently in an MDE, confirmed using the Mini International...
- Participant's current MDE has a duration of ≥6 weeks and ≤24 months. Key
- Participant has a primary diagnosis of a mood disorder other than MDD.
- Participant has a history of any of the following: MDD with psychotic or catatonic features; MDD with mixed features; Bipolar I or II disorder; Obsessive-compulsive disorder; Schizophrenia, primary thought disorder, or...
- Participant has a current diagnosis of any of the following: MDD with seasonal pattern; Depression with peripartum or perimenopausal onset; Post traumatic stress disorder; Antisocial or borderline personality disorder...
- Participant has a substance (excluding tobacco) or alcohol use disorder within the 12 months prior to screening.
- Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 2 years, or \>1 suicide attempt \>24 years of age.
- Participant has a history of non-suicidal self-harm behavior in the 12 months prior to screening.
- Participant has used antidepressants or other prohibited medications (including benzodiazepines), within the 2 weeks (4 weeks for fluoxetine) or within a period less than 5 times the drug's half-life, whichever is...
- Participant has a history of non-response to ≥2 antidepressant drugs of adequate dose and duration in the current MDE as determined by the Antidepressant Treatment Response Questionnaire (ATRQ).
- 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
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Rogers, Arkansas, United States
- Glendale, California, United States
- Huntington Beach, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Oceanside, California, United States
- Orange, California, United States
- Torrance, California, United States
- Walnut Creek, California, United States
- Cromwell, Connecticut, United States
- Coral Springs, Florida, United States
- Hialeah, Florida, United States
- Jacksonville, Florida, United States
- Lakeland, Florida, United States
- Largo, Florida, United States
- Miami, Florida, United States
- Miami Beach, Florida, United States
- North Miami Beach, Florida, United States
+ 21 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 Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Rogers, Arkansas, United States; Glendale, California, United States; Huntington Beach, California, United States; Irvine, California, United States and 35 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.