- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04832425
A Clinical Trial of PRAX-114 in Participants With Major Depressive Disorder
July 20, 2022 updated by: Praxis Precision Medicines
A Phase 2/3 Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
216
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Victoria
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Noble Park, Victoria, Australia, 3174
- Praxis Research Site
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Arizona
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Phoenix, Arizona, United States, 85012
- Praxis Research Site
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California
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Garden Grove, California, United States, 92845
- Praxis Research Site
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Lafayette, California, United States, 94549
- Praxis Research Site
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Lemon Grove, California, United States, 91945
- Praxis Research Site
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Oceanside, California, United States, 92056
- Praxis Research Site
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Pico Rivera, California, United States, 90660
- Praxis Research Site
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Redlands, California, United States, 92374
- Praxis Research Site
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Florida
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Jacksonville, Florida, United States, 32256
- Praxis Research Site
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Orange City, Florida, United States, 32763
- Praxis Research Site
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Orlando, Florida, United States, 32801
- Praxis Research Site
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Georgia
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Atlanta, Georgia, United States, 30331
- Praxis Research Site
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Decatur, Georgia, United States, 30030
- Praxis Research Site
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Illinois
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Chicago, Illinois, United States, 60076
- Praxis Research Site
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Maryland
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Gaithersburg, Maryland, United States, 20877
- Praxis Research Site
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Massachusetts
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Worcester, Massachusetts, United States, 01655
- Praxis Research Site
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Missouri
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O'Fallon, Missouri, United States, 63368
- Praxis Research Site
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Nevada
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Las Vegas, Nevada, United States, 89102
- Praxis Research Site
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New Jersey
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Berlin, New Jersey, United States, 08009
- Praxis Research Site
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Marlton, New Jersey, United States, 08053
- Praxis Research Site
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New York
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Cedarhurst, New York, United States, 11516
- Praxis Research Site
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Rochester, New York, United States, 14618
- Praxis Research Site
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Staten Island, New York, United States, 10312
- Praxis Research Site
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Ohio
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Dayton, Ohio, United States, 45417
- Praxis Research Site
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Pennsylvania
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Allentown, Pennsylvania, United States, 18104
- Praxis Research Site
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Media, Pennsylvania, United States, 19063
- Praxis Research Site
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Tennessee
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Memphis, Tennessee, United States, 38119
- Praxis Research Site
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Texas
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Austin, Texas, United States, 78737
- Praxis Research Site
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San Antonio, Texas, United States, 78229
- Praxis Research Site
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Virginia
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Charlottesville, Virginia, United States, 22903
- Praxis Research Site
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Washington
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Everett, Washington, United States, 98201
- Praxis Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Placebo once daily
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Placebo once daily
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Experimental: PRAX-114
40 mg PRAX-114 once daily
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40 mg once daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in 17-Item Hamilton Depression Rating Scale (HAM-D17) total score at Day 15
Time Frame: 15 days
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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.
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15 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in HAM-D17 total score at Day 29
Time Frame: 29 days
|
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.
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29 days
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Incidence and severity of Adverse Events (AE)
Time Frame: 43 days
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An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
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43 days
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Change from baseline in HAM-D17 total score at all other time points
Time Frame: 8 days, 22 days, 36 days, and 43 days
|
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.
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8 days, 22 days, 36 days, and 43 days
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Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 15 and all other time points
Time Frame: 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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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).
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8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Clinical Global Impression-Improvement (CGI-I) score at Day 15 and all other time points
Time Frame: 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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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).
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8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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HAM-D17 response (reduction from baseline score of ≥50%) at Day 15, Day 29, and all other time points
Time Frame: 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
|
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.
|
8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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HAM-D17 remission (total score of ≤7) at Day 15, Day 29, and all other time points
Time Frame: 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
|
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.
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8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Change from baseline in the Symptoms of Depression Questionnaire (SDQ) total and sub-scale scores at Day 15 and all other time points
Time Frame: 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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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.
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8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Patient Global Impression-Improvement (PGI-I) score at Day 15 and all other time points
Time Frame: 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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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).
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8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Change from baseline in the Work and Social Adjustment Scale (WSAS) at Day 15 and all other time points
Time Frame: 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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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.
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8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Change from baseline in the 12-Item Short Form Survey (SF-12) at Day 15 and all other time points
Time Frame: 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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The SF-12 is composed of 12 questions covering 8 dimensions of health: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health.
Total scores range from 0 (worse health) to 100 (better health).
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8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Incidence of AEs by preferred term
Time Frame: Up to 43 days
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The incidence of AEs will be reported by preferred term, including any terms related to clinically significant changes in body temperature, pulse rate, respiratory rate, blood pressure (systolic and diastolic), clinical laboratory measures (chemistry, hematology, urinalysis, and coagulation), and electrocardiogram parameters (heart rate, PR, QRS, QT, and corrected QT intervals).
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Up to 43 days
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Incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) measured suicidal ideation or behavior
Time Frame: Up to 43 days
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The C-SSRS is composed of 5 yes/no questions addressing suicidal behavior and 5 yes/no questions addressing suicidal ideation, with sub-questions assessing the severity.
Incidence is measured as the number of "yes" answers indicating the presence of suicidal ideation or behavior.
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Up to 43 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 30, 2021
Primary Completion (Actual)
May 5, 2022
Study Completion (Actual)
May 5, 2022
Study Registration Dates
First Submitted
March 19, 2021
First Submitted That Met QC Criteria
April 2, 2021
First Posted (Actual)
April 5, 2021
Study Record Updates
Last Update Posted (Actual)
July 21, 2022
Last Update Submitted That Met QC Criteria
July 20, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRAX-114-213
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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