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Study identifier: NCT04832425 Synced from ClinicalTrials.gov · August 09, 2026
● Study status: Completed

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

Condition: Major Depressive Disorder  ·  Sponsor: Praxis Precision Medicines

PhasePhase 2/Phase 3
Planned participants216
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where31 locations · 2 countries
For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.Open the site landscape →

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (31)

Praxis Research SitePhoenix, Arizona, United States
Praxis Research SiteGarden Grove, California, United States
Praxis Research SiteLafayette, California, United States
Praxis Research SiteLemon Grove, California, United States
Praxis Research SiteOceanside, California, United States
Praxis Research SitePico Rivera, California, United States
Praxis Research SiteRedlands, California, United States
Praxis Research SiteJacksonville, Florida, United States
Praxis Research SiteOrange City, Florida, United States
Praxis Research SiteOrlando, Florida, United States
Praxis Research SiteAtlanta, Georgia, United States
Praxis Research SiteDecatur, Georgia, United States

+ 19 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

PhoenixGarden GroveLafayetteLemon Grove

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