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

NCT ID: NCT04969510

Last Updated: 2022-08-19

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

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-24

Study Completion Date

2022-08-02

Brief Summary

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This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of 10, 20, 40 and 60 mg oral PRAX-114 compared to placebo in the treatment of adults with MDD. The study will enroll participants on adjunctive treatment who had an inadequate response to their current antidepressant treatment and participants not currently being treated with pharmacotherapy for MDD. A sub-study to investigate the pharmacokinetics (PK) of PRAX-114 and metabolites when dosed in the evening in participants with MDD will be conducted in a subset of participants at selected research sites with serial PK sampling capabilities.

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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 (10 mg)

10 mg PRAX-114 once daily

Group Type EXPERIMENTAL

10 mg PRAX-114

Intervention Type DRUG

Once daily oral treatment

PRAX-114 (20 mg)

20 mg PRAX-114 once daily

Group Type EXPERIMENTAL

20 mg PRAX-114

Intervention Type DRUG

Once daily oral treatment

PRAX-114 (40 mg)

40 mg PRAX-114 once daily

Group Type EXPERIMENTAL

40 mg PRAX-114

Intervention Type DRUG

Once daily oral treatment

PRAX-114 (60 mg)

60 mg PRAX-114 once daily

Group Type EXPERIMENTAL

60 mg PRAX-114

Intervention Type DRUG

Once daily oral treatment

Placebo

Placebo once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily oral treatment

Interventions

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10 mg PRAX-114

Once daily oral treatment

Intervention Type DRUG

20 mg PRAX-114

Once daily oral treatment

Intervention Type DRUG

40 mg PRAX-114

Once daily oral treatment

Intervention Type DRUG

60 mg PRAX-114

Once daily oral treatment

Intervention Type DRUG

Placebo

Once daily oral treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Recurrent MDD diagnosis with a current episode duration of at least 12 weeks and no more than 24 months.
2. HAM-D17 total score of ≥20 at Screening and Baseline
3. Body mass index (BMI) between 18 and 38 kg/m2 (inclusive).
4. Adjunctive treatment participants only: Inadequate response to treatment in the current MDD episode, defined as \<50% reduction in depression severity in response to at least 1 and no more than 2 antidepressant trials at an adequate dose and duration in the current MDE as specified in the ATRQ.
5. Adjunctive treatment participants only: Stable regimen of antidepressant treatment for at least 8 weeks prior to Baseline, with no clinically meaningful change (defined as no increase in dose and no decrease in dose ≥25% for tolerability) during that period.

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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Executive Director Clinical Development

Role: STUDY_DIRECTOR

Praxis Precision Mediciines

Locations

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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

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

Gaithersburg, Maryland, United States

Site Status

Praxis Research Site

Boston, Massachusetts, 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

Cedarhurst, New York, United States

Site Status

Praxis Research Site

Rochester, 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

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-114-214

Identifier Type: -

Identifier Source: org_study_id

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