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Can a new oral drug lift severe depression?

NCT ID NCT05376150

NEW Symptom relief Sponsor: Xenon Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing an experimental oral drug called XEN1101 in adults with major depressive disorder. The trial enrolls 168 people aged 18 to 65 who are in a moderate to severe depressive episode. Participants receive either 10 mg or 20 mg of XEN1101 or a placebo for six weeks. The main goal is to see whether the drug reduces depression severity, measured by a standard rating scale, and whether it improves the ability to feel pleasure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XEN1101, an experimental oral drug
What this could lead to
If XEN1101 works, it could offer a new oral option for people whose depression has not improved with current treatments.
What could go wrong
This is a Phase 2 trial with 168 participants, so any benefit seen may not hold up in larger studies. XEN1101 can cause dizziness, sleepiness, and other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

168 people

The number who actually took part.

Started

May 2022

Finished

Oct 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Be properly informed of the nature and risks of the study and given written informed consent. * Male or female, aged 18 through 65 years (inclusive) with a body mass index (BMI) ≤35 kg/m². * Subject must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current MDD and currently in a moderate to severe major depressive episode (MDE), confirmed using the Mini International Neuropsychiatric Interview (MINI). * Current MDE duration ≥2 months and \<24 months at the time of screening. * Current illness severity that is at least moderate, defined as a score of ≥20 on the HAM-D17 at screening and on Day 1. * Score ≥20 on the SHAPS at screening and on Day1. * Must be willing to comply with the study protocol for the full term of the study. Key Exclusion Criteria: * A primary psychiatric diagnosis other than MDD as defined by DSM-5 (comorbid anxiety disorders \[including agoraphobia, generalized anxiety disorder, social anxiety disorder, post-traumatic stress disorder (PTSD), and panic disorder\] are allowed). * Concomitant use of antidepressants and/or other disallowed pharmacotherapy (including benzodiazepines). * History of schizophrenia or other psychotic disorder, MDD with psychotic features, bipolar I or II disorder, or MDD with mixed features. * History of non-response to \>1 antidepressant drug due to lack of efficacy in the current MDE. * Failing \>3 antidepressant drug trials, for any reason, in the current MDE. * History of non-response to electroconvulsive therapy (ECT) in the past 10 years. * Active suicidal plan/intent in the past 6 months, or more than 1 lifetime suicide attempt. * Females who are pregnant, breastfeeding, or planning to become pregnant during the first administration of study drug until 3 months after the last dose of study drug. * Meets criteria for a substance use disorder within the past 12 months, with the exception of tobacco use, and/or has a positive urine toxicology screen for drugs of abuse. * Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.

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Conditions

The condition(s) this trial relates to.

Depression major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder

Contacts and locations

Locations

  • AIM Trials

    Plano, Texas, 75093, United States

  • Advanced Research Center

    Anaheim, California, 92805, United States

  • Altea Research

    Las Vegas, Nevada, 89102, United States

  • Artemis Institute for Clinical Research

    Riverside, California, 92503, United States

  • Artemis Institute for Clinical Research

    San Diego, California, 92103, United States

  • Bio Behavioral Health

    Toms River, New Jersey, 08755, United States

  • CCM Clinical Reseach Group, LLC

    Miami, Florida, 33133, United States

  • California Neuropsychopharmacology Clinical Research Institute

    Pico Rivera, California, 90660, United States

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75231, United States

  • Global Medical Institutes (GMI)

    Miami, Florida, 33125, United States

  • Hassman Research Institute

    Marlton, New Jersey, 08009, United States

  • Manhattan Behavioral Medicine, PLLC

    New York, New York, 10036, United States

  • Meridian International Research

    Miami, Florida, 33014, United States

  • Neurobehavioral Research, Inc. (NBR)

    Cedarhurst, New York, 11516, United States

  • Psych Atlanta, PC

    Marietta, Georgia, 30060, United States

  • Revive Research Institute, Inc.

    Elgin, Illinois, 60123, United States

  • Richard M Weisler and Association

    Raleigh, North Carolina, 27609, United States

  • Sunwise Clinical Research, LLC

    Lafayette, California, 94549, United States

  • i-Research, Atlanta

    Decatur, Georgia, 30030, United States

  • iResearch

    Savannah, Georgia, 31405, United States

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