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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04832425
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : December 7, 2021
Sponsor:
Information provided by (Responsible Party):
Praxis Precision Medicines

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: PRAX-114 Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 30, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PRAX-114
40 mg PRAX-114 once daily
Drug: PRAX-114
40 mg once daily

Placebo Comparator: Placebo
Placebo once daily
Drug: Placebo
Placebo once daily




Primary Outcome Measures :
  1. Change from baseline in 17-Item Hamilton Depression Rating Scale (HAM-D17) total score at Day 15 [ Time Frame: 15 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 ]
    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).

  4. 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 ]
    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).

  5. 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.

  6. 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.

  7. 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 ]
    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.

  8. 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 ]
    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).

  9. 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 ]
    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.

  10. 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 ]
    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).

  11. Incidence and severity of Adverse Events (AE) [ Time Frame: 43 days ]
    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.

  12. Incidence of AEs by preferred term [ Time Frame: Up to 43 days ]
    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).

  13. Incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) measured suicidal ideation or behavior [ Time Frame: Up to 43 days ]
    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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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04832425


Contacts
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Contact: Chief Medical Officer, Praxis Precision Medicines 617-300-8460 clinicaltrials@praxismedicines.com

Locations
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United States, Arizona
Praxis Research Site Recruiting
Phoenix, Arizona, United States, 85012
United States, California
Praxis Research Site Recruiting
Garden Grove, California, United States, 92845
Praxis Research Site Not yet recruiting
Lafayette, California, United States, 94549
Praxis Research Site Recruiting
Lemon Grove, California, United States, 91945
Praxis Research Site Recruiting
Oceanside, California, United States, 92056
Praxis Research Site Recruiting
Pico Rivera, California, United States, 90660
Praxis Research Site Recruiting
Redlands, California, United States, 92374
United States, Florida
Praxis Research Site Not yet recruiting
Coral Springs, Florida, United States, 33067
Praxis Research Site Recruiting
Jacksonville, Florida, United States, 32256
Praxis Research Site Recruiting
Orange City, Florida, United States, 32763
Praxis Research Site Recruiting
Orlando, Florida, United States, 32801
United States, Georgia
Praxis Research Site Recruiting
Atlanta, Georgia, United States, 30331
Praxis Research Site Recruiting
Decatur, Georgia, United States, 30030
United States, Illinois
Praxis Research Site Not yet recruiting
Chicago, Illinois, United States, 60076
United States, Maryland
Praxis Research Site Recruiting
Gaithersburg, Maryland, United States, 20877
United States, Massachusetts
Praxis Research Site Not yet recruiting
Worcester, Massachusetts, United States, 01655
United States, Missouri
Praxis Research Site Recruiting
O'Fallon, Missouri, United States, 63368
United States, Nevada
Praxis Research Site Recruiting
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Praxis Research Site Recruiting
Berlin, New Jersey, United States, 08009
Praxis Research Site Recruiting
Marlton, New Jersey, United States, 08053
United States, New York
Praxis Research Site Recruiting
Cedarhurst, New York, United States, 11516
Praxis Research Site Not yet recruiting
Rochester, New York, United States, 14618
Praxis Research Site Recruiting
Staten Island, New York, United States, 10312
United States, Ohio
Praxis Research Site Recruiting
Dayton, Ohio, United States, 45417
United States, Oregon
Praxis Research Site Recruiting
Portland, Oregon, United States, 97210
United States, Pennsylvania
Praxis Research Site Recruiting
Allentown, Pennsylvania, United States, 18104
Praxis Research Site Recruiting
Media, Pennsylvania, United States, 19063
United States, Tennessee
Praxis Research Site Recruiting
Memphis, Tennessee, United States, 38119
United States, Texas
Praxis Research Site Recruiting
Austin, Texas, United States, 78737
Praxis Research Site Recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
Praxis Research Site Not yet recruiting
Charlottesville, Virginia, United States, 22903
United States, Washington
Praxis Research Site Recruiting
Everett, Washington, United States, 98201
Australia, Queensland
Praxis Research Site Not yet recruiting
Toowong, Queensland, Australia, 4066
Australia, Victoria
Praxis Research Site Recruiting
Melbourne, Victoria, Australia, 3004
Praxis Research Site Recruiting
Noble Park, Victoria, Australia, 3174
Sponsors and Collaborators
Praxis Precision Medicines
Investigators
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Study Director: VP, Clinical Development Praxis Precision Medicines
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Responsible Party: Praxis Precision Medicines
ClinicalTrials.gov Identifier: NCT04832425    
Other Study ID Numbers: PRAX-114-213
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Praxis Precision Medicines:
Mood Disorders
Depressive Disorder
Depression
Depressive Disorder, Unipolar
Depressive Symptoms
Agents, GABA
Receptors, GABA-A
Allosteric Regulation
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms