NCT05376150

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

A Proof-of-Concept, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 in Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Xenon Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is divided into 3 stages: Screening - up to 4 weeks duration; Treatment - 6 weeks duration; Follow-up - 4 weeks duration. The total study duration per subject is estimated to be approximately 14 weeks.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	XEN1101 10 mg	XEN1101 oral capsule
DRUG	XEN1101 20 mg	XEN1101 oral capsule
DRUG	Placebo	Placebo capsule

Timeline

• Start date: 2022-05-19
• Primary completion: 2023-09-18
• Completion: 2023-10-16
• First posted: 2022-05-17
• Last updated: 2024-09-19

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study