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

Phase 2
Waitlist Available
Research Sponsored by Praxis Precision Medicines
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days

Summary

This trial is testing a new oral medication called PRAX-114 to see if it can help adults with depression, especially those who haven't had success with other treatments or aren't on any medication. The drug works by balancing brain chemicals related to mood.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in HAM-D17 total score at Day 15
Secondary study objectives
Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 15 and all other time points
Change from baseline in HAM-D17 total score at Day 29
Change from baseline in HAM-D17 total score at all other time points
+6 more
Other study objectives
Incidence and severity of Adverse Events (AE)
Incidence of AEs by preferred term
Incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) measured suicidal ideation or behavior

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: PRAX-114 (60 mg)Experimental Treatment1 Intervention
60 mg PRAX-114 once daily
Group II: PRAX-114 (40 mg)Experimental Treatment1 Intervention
40 mg PRAX-114 once daily
Group III: PRAX-114 (20 mg)Experimental Treatment1 Intervention
20 mg PRAX-114 once daily
Group IV: PRAX-114 (10 mg)Experimental Treatment1 Intervention
10 mg PRAX-114 once daily
Group V: PlaceboPlacebo Group1 Intervention
Placebo once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
60 mg PRAX-114
2021
Completed Phase 2
~110
10 mg PRAX-114
2021
Completed Phase 2
~110
20 mg PRAX-114
2021
Completed Phase 2
~110
40 mg PRAX-114
2021
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

Praxis Precision MedicinesLead Sponsor
9 Previous Clinical Trials
1,069 Total Patients Enrolled
1 Trials studying Depression
216 Patients Enrolled for Depression
Executive Director Clinical DevelopmentStudy DirectorPraxis Precision Mediciines
VP, Clinical DevelopmentStudy DirectorPraxis Precision Mediciines
7 Previous Clinical Trials
713 Total Patients Enrolled
1 Trials studying Depression
216 Patients Enrolled for Depression
~25 spots leftby Dec 2025
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