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

NCT04832425 | Completed Phase 2 FDA Drug

• 1 other identifier: PRAX-114-213
• Study Type: interventional
• Target: 216
• Locations: 2 countries
• Sites: 31

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.

Conditions

Major Depressive Disorder

Keywords

Mood Disorders; Depressive Disorder; Depression; Depressive Disorder, Unipolar; Depressive Symptoms; Agents, GABA; Receptors, GABA-A; Allosteric Regulation

Outcome Measures

Primary Outcomes (1)

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

  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.

  15 days

Secondary Outcomes (13)

• Change from baseline in HAM-D17 total score at Day 29

  29 days

• Change from baseline in HAM-D17 total score at all other time points

  8 days, 22 days, 36 days, and 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

• 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

• 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

Study Arms (2)

PRAX-114

EXPERIMENTAL

40 mg PRAX-114 once daily

Drug: PRAX-114

Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo

Interventions

PRAX-114 DRUG

40 mg once daily

PRAX-114

Placebo DRUG

Placebo once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Praxis Precision Medicines: lead

Study Sites (31)

Praxis Research Site

Phoenix, Arizona, 85012, United States

Location

Praxis Research Site

Garden Grove, California, 92845, United States

Location

Praxis Research Site

Lafayette, California, 94549, United States

Location

Praxis Research Site

Lemon Grove, California, 91945, United States

Location

Praxis Research Site

Oceanside, California, 92056, United States

Location

Praxis Research Site

Pico Rivera, California, 90660, United States

Location

Praxis Research Site

Redlands, California, 92374, United States

Location

Praxis Research Site

Jacksonville, Florida, 32256, United States

Location

Praxis Research Site

Orange City, Florida, 32763, United States

Location

Praxis Research Site

Orlando, Florida, 32801, United States

Location

Praxis Research Site

Atlanta, Georgia, 30331, United States

Location

Praxis Research Site

Decatur, Georgia, 30030, United States

Location

Praxis Research Site

Chicago, Illinois, 60076, United States

Location

Praxis Research Site

Gaithersburg, Maryland, 20877, United States

Location

Praxis Research Site

Worcester, Massachusetts, 01655, United States

Location

Praxis Research Site

O'Fallon, Missouri, 63368, United States

Location

Praxis Research Site

Las Vegas, Nevada, 89102, United States

Location

Praxis Research Site

Berlin, New Jersey, 08009, United States

Location

Praxis Research Site

Marlton, New Jersey, 08053, United States

Location

Praxis Research Site

Cedarhurst, New York, 11516, United States

Location

Praxis Research Site

Rochester, New York, 14618, United States

Location

Praxis Research Site

Staten Island, New York, 10312, United States

Location

Praxis Research Site

Dayton, Ohio, 45417, United States

Location

Praxis Research Site

Allentown, Pennsylvania, 18104, United States

Location

Praxis Research Site

Media, Pennsylvania, 19063, United States

Location

Praxis Research Site

Memphis, Tennessee, 38119, United States

Location

Praxis Research Site

Austin, Texas, 78737, United States

Location

Praxis Research Site

San Antonio, Texas, 78229, United States

Location

Praxis Research Site

Charlottesville, Virginia, 22903, United States

Location

Praxis Research Site

Everett, Washington, 98201, United States

Location

Praxis Research Site

Noble Park, Victoria, 3174, Australia

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Mood Disorders; Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• VP, Clinical Development

  Praxis Precision Medicines

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: April 5, 2021
• Study Start: March 30, 2021
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); US (30)