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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT04832425

Run by

Praxis Precision Medicines

People needed

216

Starts

2021-03-30

Expected to finish

2022-05-05

Last updated by the study team

2022-07-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recurrent MDD diagnosis with a current episode duration of at least 8 weeks and no more than 24 months.
• HAM-D17 total score of ≥23 at Screening and Baseline.
• Body mass index (BMI) between 18 and 38 kg/m2 (inclusive).

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.

Where it is running

• 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
• Praxis Research Site — Atlanta, Georgia, United States
• Praxis Research Site — Decatur, Georgia, United States
• Praxis Research Site — Chicago, Illinois, United States
• Praxis Research Site — Gaithersburg, Maryland, United States
• Praxis Research Site — Worcester, Massachusetts, United States
• Praxis Research Site — O'Fallon, Missouri, United States
• Praxis Research Site — Las Vegas, Nevada, United States
• Praxis Research Site — Berlin, New Jersey, United States
• Praxis Research Site — Marlton, New Jersey, United States
• Praxis Research Site — Cedarhurst, New York, United States
• Praxis Research Site — Rochester, New York, United States
• Praxis Research Site — Staten Island, New York, United States
• Praxis Research Site — Dayton, Ohio, United States
• Praxis Research Site — Allentown, Pennsylvania, United States
• Praxis Research Site — Media, Pennsylvania, United States

Full record on ClinicalTrials.gov

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