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

Last updated: July 20, 2022
Sponsor: Praxis Precision Medicines
Overall Status: Completed

Phase

2/3

Condition

Affective Disorders

Depression (Adult And Geriatric)

Depression

Treatment

N/A

Clinical Study ID

NCT04832425
PRAX-114-213
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Recurrent MDD diagnosis with a current episode duration of at least 8 weeks and nomore than 24 months.
  2. HAM-D17 total score of ≥23 at Screening and Baseline.
  3. Body mass index (BMI) between 18 and 38 kg/m2 (inclusive).

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 216
Study Start date:
March 30, 2021
Estimated Completion Date:
May 05, 2022

Connect with a study center

  • Praxis Research Site

    Toowong, Queensland 4066
    Australia

    Site Not Available

  • Praxis Research Site

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Praxis Research Site

    Noble Park, Victoria 3174
    Australia

    Site Not Available

  • Praxis Research Site

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Praxis Research Site

    Garden Grove, California 92845
    United States

    Site Not Available

  • Praxis Research Site

    Lafayette, California 94549
    United States

    Site Not Available

  • Praxis Research Site

    Lemon Grove, California 91945
    United States

    Site Not Available

  • Praxis Research Site

    Oceanside, California 92056
    United States

    Site Not Available

  • Praxis Research Site

    Pico Rivera, California 90660
    United States

    Site Not Available

  • Praxis Research Site

    Redlands, California 92374
    United States

    Site Not Available

  • Praxis Research Site

    Coral Springs, Florida 33067
    United States

    Site Not Available

  • Praxis Research Site

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Praxis Research Site

    Orange City, Florida 32763
    United States

    Site Not Available

  • Praxis Research Site

    Orlando, Florida 32801
    United States

    Site Not Available

  • Praxis Research Site

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • Praxis Research Site

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Praxis Research Site

    Chicago, Illinois 60076
    United States

    Site Not Available

  • Praxis Research Site

    Gaithersburg, Maryland 20877
    United States

    Site Not Available

  • Praxis Research Site

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Praxis Research Site

    O'Fallon, Missouri 63368
    United States

    Site Not Available

  • Praxis Research Site

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Praxis Research Site

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Praxis Research Site

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • Praxis Research Site

    Cedarhurst, New York 11516
    United States

    Site Not Available

  • Praxis Research Site

    Rochester, New York 14618
    United States

    Site Not Available

  • Praxis Research Site

    Staten Island, New York 10312
    United States

    Site Not Available

  • Praxis Research Site

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Praxis Research Site

    Portland, Oregon 97210
    United States

    Site Not Available

  • Praxis Research Site

    Allentown, Pennsylvania 18104
    United States

    Site Not Available

  • Praxis Research Site

    Media, Pennsylvania 19063
    United States

    Site Not Available

  • Praxis Research Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Praxis Research Site

    Austin, Texas 78737
    United States

    Site Not Available

  • Praxis Research Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Praxis Research Site

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Praxis Research Site

    Everett, Washington 98201
    United States

    Site Not Available

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