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A Clinical Trial of PRAX-114 in Participants With Major Depressive Disorder

NCT04832425 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2022-07-21

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of PRAX-114 in participants with moderate to severe major depressive disorder (MDD). Participants will be randomized to receive 28 days of either 40 mg PRAX-114 or placebo in a 1:1 ratio.

Conditions

Interventions

DRUG

PRAX-114

40 mg once daily

DRUG

Placebo

Placebo once daily

Sponsors & Collaborators

Principal Investigators

  • VP, Clinical Development · Praxis Precision Medicines

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-03-30
Primary Completion
2022-05-05
Completion
2022-05-05
FDA Drug
Yes

Countries

  • United States
  • Australia

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 NCT04832425 on ClinicalTrials.gov