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XEN1101 for Major Depressive Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE2

XEN1101 for Major Depressive Disorder

A Proof of Concept Randomized Controlled Trial of XEN1101 for the Treatment of Major Depressive Disorder

NCT04827901•James Murrough

Summary

This project is designed to examine the neuronal KCNQ2/3 potassium (K+) channel subtype as a novel treatment target for mood disorders through the administration of the KCNQ-selective channel opener XEN1101 (Xenon Pharmaceuticals).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent (and assent when applicable) obtained from subject
•2. Ability for subject to comply with the requirements of the study as determined by the PI;
•3. Men and women, age 18-65 years;
•4. Participants must meet DSM-5 criteria for current depressive disorder (major depressive disorder \[MDD\]) in a major depressive episode (MDE) as determined by a study psychiatrist and confirmed using the Structured Clinical Interview for DSM-5 Research Version (SCID-5-RV);
•5. Clinically significant anhedonia as determined by a SHAPS score ≥ 20 at screening;
•6. Current illness severity is at least moderate, defined as a score of ≥4 on the CGI-S Scale;
•7. If female of childbearing potential, must agree to use of a medically accepted form of contraception, or else agree to abstinence until 6 months after the last dose of study drug.

Exclusion Criteria

•1. A primary psychiatric diagnosis other than MDD as defined by DSM-5;
•2. Has a history of schizophrenia or other psychotic disorder, major depressive disorder with psychotic features, or bipolar I or II disorder.
•3. History of non-response to \>4 adequate antidepressant trials in the current episode as determined by the Antidepressant Treatment Response Questionnaire (ATRQ);
•4. History of non-response to electroconvulsive therapy in the current depressive episode;
•5. A current diagnosis of depression with peripartum onset;
•6. Diagnosis of a major neurocognitive disorder;
•7. Meets criteria for a substance use disorder within the past 6 months, with the exception of nicotine use disorder;
•8. Patient shows signs of retinal macular disease, or retinal pigment epithelium abnormality prior to randomization.
•9. Male patients, if heterosexually active with partner who is female of childbearing potential, pregnant, or breastfeeding, who are unwilling to agree to barrier contraception for the treatment period and for at least 6 months after the last dose of study drug. Female partners of male participants who are unwilling to use at least one form of highly effective contraception starting at least one cycle prior to male patient study drug initiation until 6 months after the last dose of study drug.
•10. Female participants who are pregnant, breastfeeding, or may become pregnant, or unwilling to practice birth control during participation in the study or the 6 months following;
+10 more criteria

Locations (2)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Baylor College of Medicine

Houston, Texas, United States

Key Dates

Start Date

October 19, 2021

Primary Completion Date

October 3, 2024

Completion Date

November 7, 2024

Last Updated

April 2, 2025

Enrollment

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

XEN1101

DRUG

Placebo

DRUG

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

NCT07115329

Major Depressive Disorder

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RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

NCT06793397

Major Depressive Disorder (MDD)Depression in Adults+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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XEN1101 for Major Depressive Disorder

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Preliminary Efficacy Trial of a Digital Intervention for Depression and Cannabis Use