Actively Recruiting
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder
Led by Xenon Pharmaceuticals Inc. · Updated on 2025-10-22
450
Participants Needed
46
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating azetukalner as a monotherapy in adults diagnosed with Major Depressive Disorder (MDD) in this Phase 3, multicenter, randomized, double-blind, placebo-controlled study. The trial aims to assess the clinical efficacy, safety, and tolerability of azetukalner compared to placebo in adults with moderate-to-severe MDD, focusing on changes in depression severity over a 6-week treatment period. Participants will receive either azetukalner 20 mg or a matching placebo, taken orally once daily with food, preferably with the evening meal, for 6 weeks. The study includes a screening period of approximately 4 weeks before baseline and monitors participants through 8 weeks after the final dose to assess safety. The trial is designed with two treatment arms and uses quadruple masking to ensure unbiased results. During the study, participants will undergo regular assessments including the Hamilton Depression Rating Scale (HAMD-17) at baseline, Week 1, and Week 6, the Snaith-Hamilton Pleasure Scale (SHAPS), and the Clinical Global Impression of Severity (CGI-S) scale. Safety and tolerability are evaluated throughout the study and follow-up periods by monitoring adverse events. Overall participation lasts from screening through 8 weeks post-treatment, with close attention to depression symptoms and participant well-being.
CONDITIONS
Brief Title
A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 74 years of age
- Experienced first major depressive episode before age 50
- Body Mass Index (BMI) of 40 kg/m2 or less
- Meets DSM-5-TR criteria for current major depressive disorder and is currently in a major depressive episode confirmed by the Mini International Neuropsychiatric Interview (MINI)
- Current major depressive episode duration between 6 weeks and 24 months
You will not qualify if you...
- Primary diagnosis of mood disorder other than Major Depressive Disorder
- History of 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 disorders
- Current diagnosis of MDD with seasonal pattern, depression with peripartum or perimenopausal onset, post traumatic stress disorder, antisocial or borderline personality disorder, panic disorder and/or agoraphobia, or ADHD treated with psychostimulants during current episode or unstable symptoms
- 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 in last 2 years, or more than one suicide attempt after age 24
- History of non-suicidal self-harm behavior within 12 months prior to screening
- Use of antidepressants or prohibited medications within 2 weeks (4 weeks for fluoxetine) or within less than 5 times the drug's half-life prior to randomization
- History of non-response to two or more antidepressant drugs during current major depressive episode
- Medical conditions interfering with study purposes or conduct
- 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 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 after completing treatment.
Visits as needed for safety monitoring
Trial Site Locations
Total: 46 locations
1
IMA Clinical Research Phoenix
Phoenix, Arizona, United States, 85012
Actively Recruiting
2
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
Actively Recruiting
3
Woodland Research Northwest
Rogers, Arkansas, United States, 72758
Actively Recruiting
4
Behavioral Research Specialists, Llc
Glendale, California, United States, 91206
Actively Recruiting
5
Marvel Clinical Research
Huntington Beach, California, United States, 92647
Actively Recruiting
6
Irvine Clinical Research
Irvine, California, United States, 92614
Actively Recruiting
7
CalNeuro Research Group, Inc.
Los Angeles, California, United States, 90025
Actively Recruiting
8
Excell Research Inc.
Oceanside, California, United States, 92056
Actively Recruiting
9
Atp Clinical Research
Orange, California, United States, 92866
Actively Recruiting
10
Nrc Research Institute
Orange, California, United States, 92868
Actively Recruiting
11
CenExel CNS-TO (Collaborative Neuroscience Research)
Torrance, California, United States, 90504
Actively Recruiting
12
Sunwise Clinical Research
Walnut Creek, California, United States, 94596
Actively Recruiting
13
Ct Clinical Research Associates
Cromwell, Connecticut, United States, 06416
Actively Recruiting
14
CNS Clinical Research Group
Coral Springs, Florida, United States, 33067
Actively Recruiting
15
NeoClinical Research
Hialeah, Florida, United States, 33016
Actively Recruiting
16
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32256
Actively Recruiting
17
Accel Research Sites Lakeland
Lakeland, Florida, United States, 33803
Actively Recruiting
18
Accel Research Sites - St. Petersburg-Largo
Largo, Florida, United States, 33777
Actively Recruiting
19
PharmaSouth Research
Miami, Florida, United States, 33165
Actively Recruiting
20
Quantum Clinical Trials
Miami Beach, Florida, United States, 33140
Terminated
21
Harmony Clinical Research Inc
North Miami Beach, Florida, United States, 33162
Actively Recruiting
22
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32801
Actively Recruiting
23
Combined Research Orlando Phase I-Iv
Orlando, Florida, United States, 32807
Actively Recruiting
24
Panhandle Research and Medical Clinic
Pensacola, Florida, United States, 32503
Actively Recruiting
25
Advanced Discovery Research
Atlanta, Georgia, United States, 30318
Actively Recruiting
26
Synexus - Atlanta
Atlanta, Georgia, United States, 30328
Actively Recruiting
27
CenExel iResearch
Decatur, Georgia, United States, 30030
Actively Recruiting
28
Psych Atlanta, Pc
Marietta, Georgia, United States, 30060
Actively Recruiting
29
Cenexel Iresearch - Savannah
Savannah, Georgia, United States, 31405
Actively Recruiting
30
Northwest Clinical Trials Inc
Boise, Idaho, United States, 83704
Actively Recruiting
31
Chicago Research Center Inc.
Chicago, Illinois, United States, 60634
Actively Recruiting
32
Boston Clinical Trials Llc
Boston, Massachusetts, United States, 02131
Actively Recruiting
33
ELIXIA
Springfield, Massachusetts, United States, 01103
Actively Recruiting
34
IMA Clinical Research Las Vegas
Las Vegas, Nevada, United States, 89102
Actively Recruiting
35
Redbird Research
Las Vegas, Nevada, United States, 89119
Actively Recruiting
36
IMA Clinical Research
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
37
Integrative Clinical Trials
Brooklyn, New York, United States, 11229
Actively Recruiting
38
Richmond Behavioral Associates
Staten Island, New York, United States, 10314
Actively Recruiting
39
New Hope Clinical Research
Charlotte, North Carolina, United States, 28211
Actively Recruiting
40
Pahl Pharmaceutical Professionals Llc
Oklahoma City, Oklahoma, United States, 73112
Actively Recruiting
41
Lehigh Center For Clinical Research
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
42
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States, 38119
Actively Recruiting
43
Delricht Research - Plano
Plano, Texas, United States, 75024
Actively Recruiting
44
Aim Trials, Llc
Plano, Texas, United States, 75093
Actively Recruiting
45
Grayline Research Center
Wichita Falls, Texas, United States, 76309
Actively Recruiting
46
Core Clinical Research
Everett, Washington, United States, 98201
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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