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

Sponsor
Praxis Precision Medicines (Industry)
Overall Status
Completed
CT.gov ID
NCT04832425
Collaborator
(none)
216
31
2
13.2
7
0.5

Study Details

Study Description

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
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
216 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 :
Mar 30, 2021
Actual Primary Completion Date :
May 5, 2022
Actual Study Completion Date :
May 5, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in 17-Item Hamilton Depression Rating Scale (HAM-D17) total score at Day 15 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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) [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Praxis Research Site Phoenix Arizona United States 85012
2 Praxis Research Site Garden Grove California United States 92845
3 Praxis Research Site Lafayette California United States 94549
4 Praxis Research Site Lemon Grove California United States 91945
5 Praxis Research Site Oceanside California United States 92056
6 Praxis Research Site Pico Rivera California United States 90660
7 Praxis Research Site Redlands California United States 92374
8 Praxis Research Site Jacksonville Florida United States 32256
9 Praxis Research Site Orange City Florida United States 32763
10 Praxis Research Site Orlando Florida United States 32801
11 Praxis Research Site Atlanta Georgia United States 30331
12 Praxis Research Site Decatur Georgia United States 30030
13 Praxis Research Site Chicago Illinois United States 60076
14 Praxis Research Site Gaithersburg Maryland United States 20877
15 Praxis Research Site Worcester Massachusetts United States 01655
16 Praxis Research Site O'Fallon Missouri United States 63368
17 Praxis Research Site Las Vegas Nevada United States 89102
18 Praxis Research Site Berlin New Jersey United States 08009
19 Praxis Research Site Marlton New Jersey United States 08053
20 Praxis Research Site Cedarhurst New York United States 11516
21 Praxis Research Site Rochester New York United States 14618
22 Praxis Research Site Staten Island New York United States 10312
23 Praxis Research Site Dayton Ohio United States 45417
24 Praxis Research Site Allentown Pennsylvania United States 18104
25 Praxis Research Site Media Pennsylvania United States 19063
26 Praxis Research Site Memphis Tennessee United States 38119
27 Praxis Research Site Austin Texas United States 78737
28 Praxis Research Site San Antonio Texas United States 78229
29 Praxis Research Site Charlottesville Virginia United States 22903
30 Praxis Research Site Everett Washington United States 98201
31 Praxis Research Site Noble Park Victoria Australia 3174

Sponsors and Collaborators

  • Praxis Precision Medicines

Investigators

  • Study Director: VP, Clinical Development, Praxis Precision Medicines

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Praxis Precision Medicines
ClinicalTrials.gov Identifier:
NCT04832425
Other Study ID Numbers:
  • PRAX-114-213
First Posted:
Apr 5, 2021
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Praxis Precision Medicines
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2022