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

Conditions

• Major Depressive Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• XEN1101 10 mg — DRUG
  XEN1101 oral capsule
• XEN1101 20 mg — DRUG
  XEN1101 oral capsule
• Placebo — DRUG
  Placebo capsule

Study Details

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.

Key Dates

Start date

May 19, 2022

Status verified

Sep 2024

Primary completion

Sep 18, 2023

Completion

Oct 16, 2023

Study Design

Enrollment

168 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: XEN1101 10 mg
  During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 10 mg, orally with food, per day
• Experimental: XEN1101 20 mg
  During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 20 mg, orally with food, per day
• Placebo Comparator: placebo
  During the double blind treatment period (42 days), subjects will take 1 capsule of placebo, orally with food, per day

Primary Outcome Measure

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score. [ Time Frame: From baseline to end of treatment (Week 6). ]

Locations (20)

Find similar trials in Anaheim, CA

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