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

NCT ID: NCT04832425

Last Updated: 2022-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-30

Study Completion Date

2022-05-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PRAX-114

40 mg PRAX-114 once daily

Group Type EXPERIMENTAL

PRAX-114

Intervention Type DRUG

40 mg once daily

Placebo

Placebo once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo once daily

Interventions

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PRAX-114

40 mg once daily

Intervention Type DRUG

Placebo

Placebo once daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Praxis Precision Medicines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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VP, Clinical Development

Role: STUDY_DIRECTOR

Praxis Precision Medicines

Locations

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Praxis Research Site

Phoenix, Arizona, United States

Site Status

Praxis Research Site

Garden Grove, California, United States

Site Status

Praxis Research Site

Lafayette, California, United States

Site Status

Praxis Research Site

Lemon Grove, California, United States

Site Status

Praxis Research Site

Oceanside, California, United States

Site Status

Praxis Research Site

Pico Rivera, California, United States

Site Status

Praxis Research Site

Redlands, California, United States

Site Status

Praxis Research Site

Jacksonville, Florida, United States

Site Status

Praxis Research Site

Orange City, Florida, United States

Site Status

Praxis Research Site

Orlando, Florida, United States

Site Status

Praxis Research Site

Atlanta, Georgia, United States

Site Status

Praxis Research Site

Decatur, Georgia, United States

Site Status

Praxis Research Site

Chicago, Illinois, United States

Site Status

Praxis Research Site

Gaithersburg, Maryland, United States

Site Status

Praxis Research Site

Worcester, Massachusetts, United States

Site Status

Praxis Research Site

O'Fallon, Missouri, United States

Site Status

Praxis Research Site

Las Vegas, Nevada, United States

Site Status

Praxis Research Site

Berlin, New Jersey, United States

Site Status

Praxis Research Site

Marlton, New Jersey, United States

Site Status

Praxis Research Site

Cedarhurst, New York, United States

Site Status

Praxis Research Site

Rochester, New York, United States

Site Status

Praxis Research Site

Staten Island, New York, United States

Site Status

Praxis Research Site

Dayton, Ohio, United States

Site Status

Praxis Research Site

Allentown, Pennsylvania, United States

Site Status

Praxis Research Site

Media, Pennsylvania, United States

Site Status

Praxis Research Site

Memphis, Tennessee, United States

Site Status

Praxis Research Site

Austin, Texas, United States

Site Status

Praxis Research Site

San Antonio, Texas, United States

Site Status

Praxis Research Site

Charlottesville, Virginia, United States

Site Status

Praxis Research Site

Everett, Washington, United States

Site Status

Praxis Research Site

Noble Park, Victoria, Australia

Site Status

Countries

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United States Australia

Other Identifiers

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PRAX-114-213

Identifier Type: -

Identifier Source: org_study_id

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