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

NCT04969510 | Completed Phase 2 FDA Drug

• 1 other identifier: PRAX-114-214
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 24

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

Mood Disorders; Depressive Disorder; Depression; Depressive Disorder, Unipolar; Depressive Symptoms; Agents, GABA; Receptors, GABA-A; Allosteric Regulation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HAM-D17 total score at Day 15

  The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement.

  15 days

Secondary Outcomes (9)

• Change from baseline in HAM-D17 total score at Day 29

  29 days

• Change from baseline in HAM-D17 total score at all other time points

  4 days, 8 days, 22 days, 36 days, and 43 days

• Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 15 and all other time points

  4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days

• Clinical Global Impression-Improvement (CGI-I) score at Day 15 and all other time points

  4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days

• HAM-D17 response (reduction from baseline score of ≥50%) at Day 15, Day 29, and all other time points

  4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days

Other Outcomes (3)

• Incidence and severity of Adverse Events (AE)

  43 days

• Incidence of AEs by preferred term

  43 days

• Incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) measured suicidal ideation or behavior

  43 days

Study Arms (5)

PRAX-114 (10 mg)

EXPERIMENTAL

10 mg PRAX-114 once daily

Drug: 10 mg PRAX-114

PRAX-114 (20 mg)

EXPERIMENTAL

20 mg PRAX-114 once daily

Drug: 20 mg PRAX-114

PRAX-114 (40 mg)

EXPERIMENTAL

40 mg PRAX-114 once daily

Drug: 40 mg PRAX-114

PRAX-114 (60 mg)

EXPERIMENTAL

60 mg PRAX-114 once daily

Drug: 60 mg PRAX-114

Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo

Interventions

10 mg PRAX-114 DRUG

Once daily oral treatment

PRAX-114 (10 mg)

20 mg PRAX-114 DRUG

Once daily oral treatment

PRAX-114 (20 mg)

40 mg PRAX-114 DRUG

Once daily oral treatment

PRAX-114 (40 mg)

60 mg PRAX-114 DRUG

Once daily oral treatment

PRAX-114 (60 mg)

Placebo DRUG

Once daily oral treatment

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recurrent MDD diagnosis with a current episode duration of at least 12 weeks and no more than 24 months.
• HAM-D17 total score of ≥20 at Screening and Baseline
• Body mass index (BMI) between 18 and 38 kg/m2 (inclusive).
• 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.
• 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.

You may not qualify if:

• Lifetime history of seizures, including febrile seizures.
• Neurodegenerative disorder (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, or Huntington's disease).
• 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.
• Any current psychiatric disorder (other than MDD).
• Lifetime history of treatment resistant depression.
• 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.
• Daily consumption of more than 2 standard alcohol-containing beverages for males or more than 1 standard alcohol-containing beverages for females.

Sponsors & Collaborators

• Praxis Precision Medicines: lead

Study Sites (24)

Praxis Research Site

Lafayette, California, 94549, United States

Location

Praxis Research Site

Lemon Grove, California, 91945, United States

Location

Praxis Research Site

Oceanside, California, 92056, United States

Location

Praxis Research Site

Redlands, California, 92374, United States

Location

Praxis Research Site

Jacksonville, Florida, 32256, United States

Location

Praxis Research Site

Orange City, Florida, 32763, United States

Location

Praxis Research Site

Orlando, Florida, 32801, United States

Location

Praxis Research Site

Atlanta, Georgia, 30331, United States

Location

Praxis Research Site

Decatur, Georgia, 30030, United States

Location

Praxis Research Site

Gaithersburg, Maryland, 20877, United States

Location

Praxis Research Site

Boston, Massachusetts, 02131, United States

Location

Praxis Research Site

Worcester, Massachusetts, 01655, United States

Location

Praxis Research Site

O'Fallon, Missouri, 63368, United States

Location

Praxis Research Site

Las Vegas, Nevada, 89102, United States

Location

Praxis Research Site

Cedarhurst, New York, 11516, United States

Location

Praxis Research Site

Rochester, New York, 14618, United States

Location

Praxis Research Site

Dayton, Ohio, 45417, United States

Location

Praxis Research Site

Allentown, Pennsylvania, 18104, United States

Location

Praxis Research Site

Media, Pennsylvania, 19063, United States

Location

Praxis Research Site

Memphis, Tennessee, 38119, United States

Location

Praxis Research Site

Austin, Texas, 78737, United States

Location

Praxis Research Site

Charlottesville, Virginia, 22903, United States

Location

Praxis Research Site

Everett, Washington, 98201, United States

Location

Praxis Research Site

Noble Park, Victoria, 3174, Australia

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Mood Disorders; Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Executive Director Clinical Development

  Praxis Precision Mediciines

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 20, 2021
• Study Start: June 24, 2021
• Primary Completion: July 15, 2022
• Study Completion: August 2, 2022
• Last Updated: August 19, 2022

Record last verified: 2022-08

Locations

AU (1); US (23)