Back to resultsA Clinical Trial of Adjunctive and Monotherapy PRAX-114 in Participants With Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
10 mg PRAX-114
20 mg PRAX-114
40 mg PRAX-114
60 mg PRAX-114
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Mood Disorders, Depressive Disorder, Depression, Depressive Disorder, Unipolar, Depressive Symptoms, Agents, GABA, Receptors, GABA-A, Allosteric Regulation
Eligibility Criteria
Inclusion Criteria:
- Recurrent MDD diagnosis with a current episode duration of at least 12 weeks and no more than 24 months.
- HAM-D17 total score of ≥20 at Screening and Baseline
- Body mass index (BMI) between 18 and 38 kg/m2 (inclusive).
- Adjunctive treatment participants only: Inadequate response to treatment in the current MDD episode, defined as <50% reduction in depression severity in response to at least 1 and no more than 2 antidepressant trials at an adequate dose and duration in the current MDE as specified in the ATRQ.
- Adjunctive treatment participants only: Stable regimen of antidepressant treatment for at least 8 weeks prior to Baseline, with no clinically meaningful change (defined as no increase in dose and no decrease in dose ≥25% for tolerability) during that period.
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.
Sites / Locations
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
PRAX-114 (10 mg)
PRAX-114 (20 mg)
PRAX-114 (40 mg)
PRAX-114 (60 mg)
Placebo
Arm Description
10 mg PRAX-114 once daily
20 mg PRAX-114 once daily
40 mg PRAX-114 once daily
60 mg PRAX-114 once daily
Placebo once daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
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).
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.
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.
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.
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).
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.
Full Information
NCT ID
NCT04969510
First Posted
July 8, 2021
Last Updated
August 18, 2022
Sponsor
Praxis Precision Medicines
1. Study Identification
Unique Protocol Identification Number
NCT04969510
Brief Title
A Clinical Trial of Adjunctive and Monotherapy PRAX-114 in Participants With Major Depressive Disorder
Official Title
A Phase 2 Double-blind, Placebo-Controlled, Dose-Ranging Clinical Trial to Evaluate the Efficacy and Safety of PRAX-114 in Adjunctive and Monotherapy Treatment of Participants With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 24, 2021 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
August 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Praxis Precision Medicines
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Mood Disorders, Depressive Disorder, Depression, Depressive Disorder, Unipolar, Depressive Symptoms, Agents, GABA, Receptors, GABA-A, Allosteric Regulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRAX-114 (10 mg)
Arm Type
Experimental
Arm Description
10 mg PRAX-114 once daily
Arm Title
PRAX-114 (20 mg)
Arm Type
Experimental
Arm Description
20 mg PRAX-114 once daily
Arm Title
PRAX-114 (40 mg)
Arm Type
Experimental
Arm Description
40 mg PRAX-114 once daily
Arm Title
PRAX-114 (60 mg)
Arm Type
Experimental
Arm Description
60 mg PRAX-114 once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once daily
Intervention Type
Drug
Intervention Name(s)
10 mg PRAX-114
Intervention Description
Once daily oral treatment
Intervention Type
Drug
Intervention Name(s)
20 mg PRAX-114
Intervention Description
Once daily oral treatment
Intervention Type
Drug
Intervention Name(s)
40 mg PRAX-114
Intervention Description
Once daily oral treatment
Intervention Type
Drug
Intervention Name(s)
60 mg PRAX-114
Intervention Description
Once daily oral treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily oral treatment
Primary Outcome Measure Information:
Title
Change from baseline in HAM-D17 total score at Day 15
Description
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
Secondary Outcome Measure Information:
Title
Change from baseline in HAM-D17 total score at Day 29
Description
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
Title
Change from baseline in HAM-D17 total score at all other time points
Description
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
Title
Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 15 and all other time points
Description
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
Title
Clinical Global Impression-Improvement (CGI-I) score at Day 15 and all other time points
Description
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
Title
HAM-D17 response (reduction from baseline score of ≥50%) at Day 15, Day 29, and all other time points
Description
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
Title
HAM-D17 remission (total score of ≤7) at Day 15, Day 29, and all other time points
Description
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
Title
Change from baseline in the Symptoms of Depression Questionnaire (SDQ) total and sub-scale scores at Day 15 and all other time points
Description
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
Title
Patient Global Impression-Improvement (PGI-I) score at Day 15 and all other time points
Description
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
Title
Change from baseline in the Work and Social Adjustment Scale (WSAS) at Day 15 and all other time points
Description
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
Other Pre-specified Outcome Measures:
Title
Incidence and severity of Adverse Events (AE)
Description
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.
Time Frame
43 days
Title
Incidence of AEs by preferred term
Description
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).
Time Frame
43 days
Title
Incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) measured suicidal ideation or behavior
Description
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.
Time Frame
43 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recurrent MDD diagnosis with a current episode duration of at least 12 weeks and no more than 24 months.
HAM-D17 total score of ≥20 at Screening and Baseline
Body mass index (BMI) between 18 and 38 kg/m2 (inclusive).
Adjunctive treatment participants only: Inadequate response to treatment in the current MDD episode, defined as <50% reduction in depression severity in response to at least 1 and no more than 2 antidepressant trials at an adequate dose and duration in the current MDE as specified in the ATRQ.
Adjunctive treatment participants only: Stable regimen of antidepressant treatment for at least 8 weeks prior to Baseline, with no clinically meaningful change (defined as no increase in dose and no decrease in dose ≥25% for tolerability) during that period.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Executive Director Clinical Development
Organizational Affiliation
Praxis Precision Mediciines
Official's Role
Study Director
Facility Information:
Facility Name
Praxis Research Site
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Facility Name
Praxis Research Site
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Praxis Research Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Praxis Research Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Praxis Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Praxis Research Site
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Praxis Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Praxis Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Praxis Research Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Praxis Research Site
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Praxis Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Praxis Research Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Praxis Research Site
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
Facility Name
Praxis Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Praxis Research Site
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Praxis Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Praxis Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Praxis Research Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Praxis Research Site
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Praxis Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Praxis Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
Praxis Research Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Praxis Research Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Praxis Research Site
City
Noble Park
State/Province
Victoria
ZIP/Postal Code
3174
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial of Adjunctive and Monotherapy PRAX-114 in Participants With Major Depressive Disorder
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