Recruiting NCT06775379
A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Azetukalner, Placebo.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder. Basic parameters: 18 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder
Overview
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)
Interventions
- Drug Azetukalner
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks - Drug Placebo
Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks
Primary outcome measures
- Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6 [Time frame: Baseline to Week 6]
Secondary outcome measures (4)
- Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) score at Week 6 [Time frame: Baseline to Week 6]
- Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 1 [Time frame: Baseline to Week 1]
- Change from baseline in the Clinical Global Impression of Severity (CGI-S) score at Week 6 [Time frame: Baseline to Week 6]
- To assess the safety and tolerability of azetukalner (e.g., adverse events) [Time frame: From screening (approximately 4 weeks prior to baseline) through to 8 weeks post-final dose.]
Eligibility criteria
Inclusion 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 Neuropsychiatric Interview (MINI)
- Participant's current MDE has a duration of ≥6 weeks and ≤24 months.
Exclusion criteria
- 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 other psychotic disorder.
- 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 (or presence of clinically significant borderline personality traits); Panic disorder and/or agoraphobia; ADHD treated with a psychostimulant, diagnosed during the current MDE, or with unstable symptoms, as judged by the investigator.
- 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 longer, prior to randomization.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 51 centers
- IMA Clinical Research Phoenix — Phoenix
- Woodland International Research Group — Little Rock
- Woodland Research Northwest — Rogers
- Behavioral Research Specialists, Llc — Glendale
- Marvel Clinical Research — Huntington Beach
- Irvine Clinical Research — Irvine
- CalNeuro Research Group, Inc. — Los Angeles
- Excell Research Inc. — Oceanside
- … and 43 more centers
Identifiers
NCT: NCT06775379 · XPF-010-D301