NCT04969510

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

A Phase 2 Double-blind, Placebo-Controlled, Dose-Ranging Clinical Trial to Evaluate the Efficacy and Safety of PRAX-114 in Adjunctive and Monotherapy Treatment of Participants With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Praxis Precision Medicines · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Major Depressive Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-24
• Primary completion: 2022-07-15
• Completion: 2022-08-02
• First posted: 2021-07-20
• Last updated: 2022-08-19

Locations

24 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study