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XEN1101 for Depression

Phase 2
Recruiting
Led By James W Murrough, MD, PhD
Research Sponsored by James Murrough
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women, age 18-65 years;
Are you willing to not take any other psychotropic medications during the trial?
Must not have
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Has a history of schizophrenia or other psychotic disorder, major depressive disorder with psychotic features, or bipolar I or II disorder.
Timeline
Screening 6 weeks
Treatment 8 weeks
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial is testing a new treatment for mood disorders that involves a potassium channel subtype. The goal is to see if the channel opener XEN1101 is effective.

Who is the study for?
This trial is for men and women aged 18-65 with moderate to severe Major Depressive Disorder, as confirmed by a psychiatrist using the SCID-5-RV. Participants must not take other psychotropic meds during the study, have significant anhedonia (SHAPS score ≥20), and be able to follow study requirements. Exclusions include depression with peripartum onset, recent suicide attempts, swallowing issues, major neurocognitive disorders, or unstable medical conditions.Check my eligibility
What is being tested?
The trial is testing XEN1101—a drug that targets specific brain potassium channels—as a potential new treatment for depression against a placebo. The goal is to see if XEN1101 can improve symptoms in those who haven't responded well to other treatments.See study design
What are the potential side effects?
While side effects of XEN1101 are not detailed here, similar medications may cause changes in heart rhythm (QT prolongation), liver enzyme elevations, skin or eye pigment changes. Side effects often vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
You have a health condition that could affect your safety during the trial or the accuracy of the study results.
Select...
You have a history of severe mental illnesses such as schizophrenia, bipolar disorder or major depression with psychotic features.
Select...
You have been diagnosed with depression during pregnancy or after giving birth.
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You have attempted suicide within the past two years.

Timeline

Screening ~ 6 weeks
Treatment ~ 8 weeks
Follow Up ~4 weeks
This trial's timeline: 6 weeks for screening, 8 weeks for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in activation within the reward circuit by fMRI
Secondary outcome measures
Change in Clinical Global Impression Scale
Change in Montgomery-Åsberg Depression Rating Scale Score
Change in Quick Inventory of Depressive Symptomatology, Self-Report [QIDS-SR] Score
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: XEN1101Active Control1 Intervention
Subjects will take two 10 mg capsules of XEN1101 daily for 8 weeks for a total daily dose of 20 mg.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will take a matching placebo daily for eight weeks.

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

James MurroughLead Sponsor
8 Previous Clinical Trials
201 Total Patients Enrolled
5 Trials studying Depression
124 Patients Enrolled for Depression
Baylor College of MedicineOTHER
1,001 Previous Clinical Trials
6,001,892 Total Patients Enrolled
28 Trials studying Depression
5,599 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,783 Previous Clinical Trials
2,689,089 Total Patients Enrolled
665 Trials studying Depression
251,374 Patients Enrolled for Depression

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04827901 — Phase 2
Depression Research Study Groups: XEN1101, Placebo
Depression Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04827901 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04827901 — Phase 2
Depression Patient Testimony for trial: Trial Name: NCT04827901 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would prospective participants be accepted at this point in the clinical trial?

"According to clinicaltrials.gov, this medical trial is currently searching for participants. It was first made public on October 19th 2021 and has since been updated as recent as November 8th 2022."

Answered by AI

What criteria must an individual meet to qualify for participation in this research?

"In order to join this clinical investigation, potential participants must be diagnosed with melancholia and should fall within the 18-65 age bracket. The researcher team is accepting a maximum of 60 enrollees."

Answered by AI

Has XEN1101 been granted regulatory clearance by the FDA?

"After careful consideration, XEN1101's safety was judged to be a 2 on the scale of 1-3. This is because current data suggests it is safe but there are no results yet which demonstrate its efficacy."

Answered by AI

Does this research extend to octogenarians?

"In line with the study's requirements, only individuals between 18 and 65 years of age are eligible for enrollment."

Answered by AI

How many individuals are partaking in this clinical experiment?

"Affirmative. Clinicaltrials.gov highlights that this clinical investigation is currently recruiting patients, after being first posted on October 19th 2021 and most recently updated on November 8th 2022. 60 individuals need to be enrolled at 2 different sites of care."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
Texas
What site did they apply to?
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
2
3+

Why did patients apply to this trial?

For help and uplifting therapy. I’m sick of struggling would like to be happy again.
PatientReceived 1 prior treatment
I currently take other medications which I have been on for years with very minimal results.
PatientReceived no prior treatments
I've tried several other drugs in the past. However, none have provided true long-term term efficacy.
PatientReceived no prior treatments
I've tried several other drugs in the past, in addition to talk therapy.. However, none have provided true long-term term efficacy.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Baylor College of Medicine: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
XEN1101 for Major Depressive Disorder
James Murrough 2021. "XEN1101 for Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04827901.
All > Mdd
~17 spots leftby Apr 2025
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