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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
110
Once daily oral treatment
Once daily oral treatment
Once daily oral treatment
Once daily oral treatment
Once daily oral treatment
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
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
Gaithersburg, Maryland, United States
...and 14 more locations
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.
Time frame: 15 days
Change from baseline in HAM-D17 total score at Day 29
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.
Time frame: 29 days
Change from baseline in HAM-D17 total score at all other time points
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.
Time frame: 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
The CGI-S assesses the clinician's impression of the participant's current depression symptoms. The clinician should use his/her total clinical experience with this patient population and rate the current severity of the participant's mental illness on a 7-point scale from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients).
Time frame: 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
The CGI-I assesses the participant's improvement (or worsening). The clinician is required to assess the participant's condition relative to Baseline (Day 1) on a 7-point scale from 1 (Very much improved) to 7 (Very much worse).
Time frame: 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
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.
Time frame: 4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
HAM-D17 remission (total score of ≤7) at Day 15, Day 29, and all other time points
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.
Time frame: 4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
Change from baseline in the Symptoms of Depression Questionnaire (SDQ) total and sub-scale scores at Day 15 and all other time points
The SDQ is a 44-item, self-report scale assessing the severity of symptoms across several subtypes of depression. Items are scored on a 7-point scale (ranging from 1 to 6). The SDQ total score is the sum of all 44 item scores and ranges from 44 to 264 with higher scores indicating worse symptoms.
Time frame: 4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
Patient Global Impression-Improvement (PGI-I) score at Day 15 and all other time points
The PGI-I scale is a global self-assessment used to rate the response of a participant's condition to therapy or intervention. It consists of 1 question that asks the participant to rate their current condition compared to how it was prior to beginning treatment on a scale of 1 (very much better) to 7 (very much worse).
Time frame: 4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
Change from baseline in the Work and Social Adjustment Scale (WSAS) at Day 15 and all other time points
The WSAS assesses the degree to which mental health problems interfere with day-to-day functioning in 5 domains: work, social leisure activities, private leisure activities, home- management, and personal relationships. The WSAS total score is the sum of the 5 item scores and ranges from 0 to 40, with higher scores indicating poorer adjustment.
Time frame: 4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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