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A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder

NCT05376150 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2024-09-19

No results posted yet for this study

Summary

This is a multicenter, Phase 2, double-blind, randomized, parallel-arm, placebo-controlled clinical trial to evaluate the efficacy, safety, and tolerability of XEN1101 in subjects with Major Depressive Disorder.

Conditions

Interventions

DRUG

XEN1101 10 mg

XEN1101 oral capsule

DRUG

XEN1101 20 mg

XEN1101 oral capsule

DRUG

Placebo

Placebo capsule

Sponsors & Collaborators

Principal Investigators

  • Study Director · Xenon Pharmaceuticals Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-19
Primary Completion
2023-09-18
Completion
2023-10-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05376150 on ClinicalTrials.gov