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A Clinical Trial of PRAX-114 in Participants With Major Depressive Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

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

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

NCT04832425•Praxis Precision Medicines

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Recurrent MDD diagnosis with a current episode duration of at least 8 weeks and no more 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 Criteria

•1. Lifetime history of seizures, including febrile seizures.
•2. Neurodegenerative disorder (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, or Huntington's disease).
•3. 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.
•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 the last year or transcranial magnetic stimulation (TMS) within the last 6 months prior to Screening.
•7. Daily consumption of more than 2 standard alcohol-containing beverages for males or more than 1 standard alcohol-containing beverages for females.

Locations (31)

Praxis Research Site

Phoenix, Arizona, United States

Praxis Research Site

Garden Grove, California, United States

Praxis Research Site

Lafayette, California, United States

Praxis Research Site

Lemon Grove, California, United States

Praxis Research Site

Oceanside, California, United States

Praxis Research Site

Pico Rivera, California, United States

Praxis Research Site

Redlands, California, United States

Praxis Research Site

Jacksonville, Florida, United States

Praxis Research Site

Orange City, Florida, United States

Praxis Research Site

Orlando, Florida, United States

Key Dates

Start Date

March 30, 2021

Primary Completion Date

May 5, 2022

Completion Date

May 5, 2022

Last Updated

July 21, 2022

Enrollment

216

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

PRAX-114

DRUG

Placebo

DRUG

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

NCT07115329

Major Depressive Disorder

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RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 21, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression