A Phase 2/3 Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of PRAX-114 in Participants With Major Depressive Disorder

Praxis Precision Medicines1 site in 1 country216 target enrollmentMarch 30, 2021

ConditionsMajor Depressive Disorder

InterventionsPRAX-114 Placebo

Overview

Phase: Phase 2
Intervention: PRAX-114
Conditions: Major Depressive Disorder
Sponsor: Praxis Precision Medicines
Enrollment: 216
Locations: 1
Primary Endpoint: Change from baseline in 17-Item Hamilton Depression Rating Scale (HAM-D17) total score at Day 15
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 30, 2021

End Date

May 5, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Praxis Precision Medicines

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Recurrent MDD diagnosis with a current episode duration of at least 8 weeks and no more than 24 months.
•HAM-D17 total score of ≥23 at Screening and Baseline.
•Body mass index (BMI) between 18 and 38 kg/m2 (inclusive).

Exclusion Criteria

•Lifetime history of seizures, including febrile seizures.
•Neurodegenerative disorder (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, or Huntington's disease).
•Lifetime history of bipolar disorder, a psychotic disorder (eg, schizophrenia or schizoaffective disorder), or obsessive compulsive disorder or a history of a psychotic mood episode in last 2 years.
•Any current psychiatric disorder (other than MDD).
•Lifetime history of treatment resistant depression.
•Received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS) within the last year or transcranial magnetic stimulation (TMS) within the last 6 months prior to Screening.
•Daily consumption of more than 2 standard alcohol-containing beverages for males or more than 1 standard alcohol-containing beverages for females.

Arms & Interventions

PRAX-114

40 mg PRAX-114 once daily

Intervention: PRAX-114

Placebo

Placebo once daily

Intervention: Placebo

Outcomes

Primary Outcomes

Change from baseline in 17-Item Hamilton Depression Rating Scale (HAM-D17) total score at Day 15

Time Frame: 15 days

The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement.

Secondary Outcomes

HAM-D17 remission (total score of ≤7) at Day 15, Day 29, and all other time points(8 days, 15 days, 22 days, 29 days, 36 days, and 43 days)
Incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) measured suicidal ideation or behavior(Up to 43 days)
Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 15 and all other time points(8 days, 15 days, 22 days, 29 days, 36 days, and 43 days)
Patient Global Impression-Improvement (PGI-I) score at Day 15 and all other time points(8 days, 15 days, 22 days, 29 days, 36 days, and 43 days)
Change from baseline in HAM-D17 total score at Day 29(29 days)
Clinical Global Impression-Improvement (CGI-I) score at Day 15 and all other time points(8 days, 15 days, 22 days, 29 days, 36 days, and 43 days)
Incidence of AEs by preferred term(Up to 43 days)
Change from baseline in HAM-D17 total score at all other time points(8 days, 22 days, 36 days, and 43 days)
HAM-D17 response (reduction from baseline score of ≥50%) at Day 15, Day 29, and all other time points(8 days, 15 days, 22 days, 29 days, 36 days, and 43 days)
Change from baseline in the Symptoms of Depression Questionnaire (SDQ) total and sub-scale scores at Day 15 and all other time points(8 days, 15 days, 22 days, 29 days, 36 days, and 43 days)
Change from baseline in the Work and Social Adjustment Scale (WSAS) at Day 15 and all other time points(8 days, 15 days, 22 days, 29 days, 36 days, and 43 days)
Change from baseline in the 12-Item Short Form Survey (SF-12) at Day 15 and all other time points(8 days, 15 days, 22 days, 29 days, 36 days, and 43 days)
Incidence and severity of Adverse Events (AE)(43 days)