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

A Major Depressive Disorder clinical trial begins in United States.

The research company Praxis Precision Medicines is conducting the clinical trial A Clinical Trial of PRAX-114 in Participants With Major Depressive Disorder.

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.

It is planned to include 200 participants.

Actual study start date is March 30, 2021. The researchers expect to complete the study by April 2022.

One primary outcome measure is Change from baseline in 17-Item Hamilton Depression Rating Scale (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.

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.

The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04832425

Clinical Research News

Upcoming Clinical Trials