Actively Recruiting
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder
Led by Xenon Pharmaceuticals Inc. · Updated on 2026-06-02
450
Participants Needed
44
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating azetukalner as a treatment for adults diagnosed with Moderate-to-Severe Major Depressive Disorder (MDD). This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the clinical effectiveness, safety, and tolerability of azetukalner when used alone in adults aged 18 to 74 years who are currently experiencing a major depressive episode. The study is sponsored by Xenon Pharmaceuticals Inc. and focuses on improving depressive symptoms over a six-week period. Participants will be randomly assigned to receive either azetukalner 20 mg or a placebo once daily, taken orally with food, preferably with the evening meal. Treatment lasts for six weeks, during which the effects of the medication will be closely monitored. The study uses a quadruple-blind design, meaning that participants, care providers, investigators, and outcome assessors will not know which treatment is given to ensure unbiased results. During the study, participants will undergo regular assessments including the Hamilton Depression Rating Scale (HAMD-17) to measure changes in depression severity from baseline to Week 6, along with other scales like the Snaith-Hamilton Pleasure Scale (SHAPS) and Clinical Global Impression of Severity (CGI-S). Safety and tolerability will be monitored from about four weeks before treatment through eight weeks after the final dose. The total participation duration covers treatment and follow-up to evaluate both short-term effects and safety outcomes.
CONDITIONS
Brief Title
A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 74 years
- Experienced first major depressive episode before age 50
- Body Mass Index (BMI) 40 kg/m2 or less
- Meets DSM-5-TR criteria for current major depressive disorder confirmed by MINI
- Current major depressive episode lasting between 6 weeks and 24 months
You will not qualify if you...
- Primary diagnosis of mood disorder other than Major Depressive Disorder
- History of psychotic or catatonic features, mixed features, Bipolar I or II, OCD, schizophrenia, or other psychotic disorders
- Current diagnosis of seasonal pattern MDD, peripartum or perimenopausal depression, PTSD, antisocial or borderline personality disorder, panic disorder or agoraphobia, unstable ADHD
- Substance or alcohol use disorder within 12 months prior to screening (excluding tobacco)
- Active suicidal plan or intent within 6 months prior to screening, suicidal behavior within 2 years, or more than one suicide attempt after age 24
- History of non-suicidal self-harm within 12 months prior to screening
- Use of antidepressants or prohibited medications within 2 weeks (4 weeks for fluoxetine) or less than 5 times drug half-life before randomization
- History of non-response to two or more antidepressants in current episode
- Medical conditions interfering with study conduct or purpose
- Pregnant, breastfeeding, or planning pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants take Azetukalner 20 mg or placebo orally once a day with food for 6 weeks.
Weekly visits for up to 6 weeks
Duration - 8 weeks post-final dose
Participants are monitored for safety and tolerability of the study medication after treatment ends.
Visits as needed during 8 weeks post-treatment
Trial Site Locations
Total: 44 locations
1
Harmonex Neuroscience Research
Dothan, Alabama, United States, 36303
Terminated
2
University of Alabama at Birmingham, Huntsville Regional Medical Campus
Huntsville, Alabama, United States, 35801
Actively Recruiting
3
Pillar Clinical Research
Bentonville, Arkansas, United States, 72712
Actively Recruiting
4
SanRo Clinical Research Group
Bryant, Arkansas, United States, 72022
Actively Recruiting
5
Clinical Innovations Inc
Bellflower, California, United States, 90706
Actively Recruiting
6
Center for Neurohealth
La Jolla, California, United States, 93037
Actively Recruiting
7
Artemis Institute for Clinical Research
San Diego, California, United States, 92103
Actively Recruiting
8
California Neuroscience Research
Sherman Oaks, California, United States, 91403
Actively Recruiting
9
Pacific Clinical Research Management Group
Upland, California, United States, 91786
Terminated
10
Institute of Living
Hartford, Connecticut, United States, 06106
Actively Recruiting
11
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States, 33912
Actively Recruiting
12
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
Actively Recruiting
13
Equipath Health and Research Tampa Bay, Llc
Riverview, Florida, United States, 33578
Actively Recruiting
14
Delricht Research
Atlanta, Georgia, United States, 30329
Actively Recruiting
15
Emory University Brain Health Center
Atlanta, Georgia, United States, 30329
Actively Recruiting
16
Advanced Quality Medical Research
Orland Park, Illinois, United States, 60462
Actively Recruiting
17
Smart Trials, LLC
Jefferson, Louisiana, United States, 70121
Actively Recruiting
18
Pharmasite Research Inc.
Baltimore, Maryland, United States, 21208-6605
Actively Recruiting
19
Adams Clinical Boston
Boston, Massachusetts, United States, 02116
Actively Recruiting
20
Activmed Practices & Research, Llc - Methuen
Methuen, Massachusetts, United States, 01844
Actively Recruiting
21
Adams Clinical Watertown
Watertown, Massachusetts, United States, 02472
Actively Recruiting
22
Vitalix Clinical, Inc
Worcester, Massachusetts, United States, 01608
Actively Recruiting
23
Psychiatric Care and Research Center
O'Fallon, Missouri, United States, 63368
Actively Recruiting
24
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, United States, 63304
Actively Recruiting
25
Lumina Clinical Research Center
Cherry Hill, New Jersey, United States, 08002
Actively Recruiting
26
Princeton Medical Institute
Princeton, New Jersey, United States, 08540
Actively Recruiting
27
Bio Behavioral Health
Toms River, New Jersey, United States, 08755
Actively Recruiting
28
Bioscience Research, LLC
Mount Kisco, New York, United States, 10549
Actively Recruiting
29
Fieve Clinical Research, Inc.
New York, New York, United States, 10017
Actively Recruiting
30
IMA Clinical Research
New York, New York, United States, 10128
Actively Recruiting
31
Magnolia Clinical Research, Llc
Cary, North Carolina, United States, 27511
Actively Recruiting
32
Insight Clinical Trials
Independence, Ohio, United States, 44195
Actively Recruiting
33
Sooner Clinical Research
Oklahoma City, Oklahoma, United States, 73116
Actively Recruiting
34
Austin Clinical Trial Partners
Austin, Texas, United States, 78737
Actively Recruiting
35
Boeson Research
Provo, Utah, United States, 84604
Actively Recruiting
36
Suomen Terveystalo Oy
Helsinki, Finland, 00180
Actively Recruiting
37
Oulu Mentalcare Oy
Oulu, Finland, 90100
Actively Recruiting
38
In Vivo Sp. z.o.o.
Bydgoszcz, Poland, 85-048
Actively Recruiting
39
Clinical Medical Research Sp. z o.o.
Katowice, Poland, 40156
Actively Recruiting
40
Praktyka Lekarska Malgorzata Wojtanowska-Bogacka
Poznan, Poland, 60192
Actively Recruiting
41
Specjalistyczna Praktyka Lekarska, Filip Rybakowski
Poznan, Poland, 60744
Actively Recruiting
42
Clinica Nutrimed Cercetare Sr
Bucharest, Romania, 020744
Actively Recruiting
43
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas
Liptovský Mikuláš, Slovakia, 03123
Actively Recruiting
44
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 8035
Actively Recruiting
Research Team
X
Xenon Medical Affairs
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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