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

NCT04969510 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-08-19

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of 10, 20, 40 and 60 mg oral PRAX-114 compared to placebo in the treatment of adults with MDD. The study will enroll participants on adjunctive treatment who had an inadequate response to their current antidepressant treatment and participants not currently being treated with pharmacotherapy for MDD. A sub-study to investigate the pharmacokinetics (PK) of PRAX-114 and metabolites when dosed in the evening in participants with MDD will be conducted in a subset of participants at selected research sites with serial PK sampling capabilities.

Conditions

Interventions

DRUG

10 mg PRAX-114

Once daily oral treatment

DRUG

20 mg PRAX-114

Once daily oral treatment

DRUG

40 mg PRAX-114

Once daily oral treatment

DRUG

60 mg PRAX-114

Once daily oral treatment

DRUG

Placebo

Once daily oral treatment

Sponsors & Collaborators

Principal Investigators

  • Executive Director Clinical Development · Praxis Precision Mediciines

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
2021-06-24
Primary Completion
2022-07-15
Completion
2022-08-02
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 NCT04969510 on ClinicalTrials.gov