A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-74
SponsorXenon Pharmaceuticals Inc.
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Azetukalner
DrugAzetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks
Placebo
DrugPlacebo taken orally once a day with food (with the evening meal when possible) for 6 weeks
Treatment groups
450 Participants
are divided into 2 treatment groupsGroup A: AzetukalnerExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6
The HAMD-17 consists of 17 items that are used to rate the severity of depression symptoms. Each item is scored in a range of 0 to 2 points or 0 to 4 points, with higher scores indicating a greater degree of depression. The score for each item is summed to compute a total score, which ranges from 0 to 52 points.
Time frame
Baseline to Week 6Secondary outcomes
1
Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) score at Week 6
The SHAPS is a 14-item self-report questionnaire used to assess anhedonia. Each item on the SHAPS is worded so that higher scores indicate greater anhedonia. A total score can be derived by summing the responses to each item. Items answered with "strongly agree" are assigned a score of 1, while "strongly disagree" responses are assigned a score of 4 points. Total scores on the SHAPS can range from 14 to 56 points, with higher scores corresponding to higher levels of anhedonia.
Time frame
Baseline to Week 62
Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 1
The HAMD-17 consists of 17 items that are used to rate the severity of depression symptoms. Each item is scored in a range of 0 to 2 points or 0 to 4 points, with higher scores indicating a greater degree of depression. The score for each item is summed to compute a total score, which ranges from 0 to 52 points.
Time frame
Baseline to Week 13
Change from baseline in the Clinical Global Impression of Severity (CGI-S) score at Week 6
The CGI-S is a clinician-rated global measure of participant overall disease severity. Participants are rated on a 7-point severity scale, with higher scores indicating more severe depression.
Time frame
Baseline to Week 64
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.Sponsors and contacts
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Source ClinicalTrials.gov