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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04832425
Additional trial details provided through ANZCTR are available at the end of this record.
Registration number
NCT04832425
Ethics application status
Date submitted
19/03/2021
Date registered
5/04/2021
Date last updated
21/07/2022
Titles & IDs
Public title
A Clinical Trial of PRAX-114 in Participants With Major Depressive Disorder
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Scientific 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
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Secondary ID [1]
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PRAX-114-213
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PRAX-114
Treatment: Drugs - Placebo
Experimental: PRAX-114 - 40 mg PRAX-114 once daily
Placebo Comparator: Placebo - Placebo once daily
Treatment: Drugs: PRAX-114
40 mg once daily
Treatment: Drugs: Placebo
Placebo once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline in 17-Item Hamilton Depression Rating Scale (HAM-D17) total score at Day 15
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Assessment method [1]
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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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Timepoint [1]
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15 days
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Secondary outcome [1]
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Change from baseline in HAM-D17 total score at Day 29
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Assessment method [1]
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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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Timepoint [1]
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29 days
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Secondary outcome [2]
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Change from baseline in HAM-D17 total score at all other time points
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Assessment method [2]
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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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Timepoint [2]
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8 days, 22 days, 36 days, and 43 days
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Secondary outcome [3]
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Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 15 and all other time points
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Assessment method [3]
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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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Timepoint [3]
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8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Secondary outcome [4]
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Clinical Global Impression-Improvement (CGI-I) score at Day 15 and all other time points
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Assessment method [4]
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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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Timepoint [4]
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8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Secondary outcome [5]
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HAM-D17 response (reduction from baseline score of =50%) at Day 15, Day 29, and all other time points
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Assessment method [5]
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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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Timepoint [5]
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8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Secondary outcome [6]
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HAM-D17 remission (total score of =7) at Day 15, Day 29, and all other time points
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Assessment method [6]
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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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Timepoint [6]
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8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Secondary outcome [7]
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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
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Assessment method [7]
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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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Timepoint [7]
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8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Secondary outcome [8]
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Patient Global Impression-Improvement (PGI-I) score at Day 15 and all other time points
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Assessment method [8]
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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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Timepoint [8]
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8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Secondary outcome [9]
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Change from baseline in the Work and Social Adjustment Scale (WSAS) at Day 15 and all other time points
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Assessment method [9]
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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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Timepoint [9]
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8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Secondary outcome [10]
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Change from baseline in the 12-Item Short Form Survey (SF-12) at Day 15 and all other time points
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Assessment method [10]
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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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Timepoint [10]
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8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Secondary outcome [11]
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Incidence and severity of Adverse Events (AE)
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Assessment method [11]
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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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Timepoint [11]
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43 days
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Secondary outcome [12]
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Incidence of AEs by preferred term
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Assessment method [12]
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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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Timepoint [12]
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Up to 43 days
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Secondary outcome [13]
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Incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) measured suicidal ideation or behavior
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Assessment method [13]
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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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Timepoint [13]
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Up to 43 days
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Eligibility
Key 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).
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Minimum age
18
Years
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Maximum age
65
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/05/2022
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Sample size
Target
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Accrual to date
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Final
216
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Praxis Research Site - Noble Park
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Recruitment postcode(s) [1]
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3174 - Noble Park
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Florida
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United States of America
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State/province [4]
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Georgia
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Country [5]
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United States of America
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State/province [5]
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Illinois
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Country [6]
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United States of America
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State/province [6]
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Maryland
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Country [7]
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United States of America
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State/province [7]
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Massachusetts
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Country [8]
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United States of America
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State/province [8]
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Missouri
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Country [9]
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United States of America
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State/province [9]
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Nevada
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Country [10]
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United States of America
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State/province [10]
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New Jersey
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Country [11]
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United States of America
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State/province [11]
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New York
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Country [12]
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United States of America
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State/province [12]
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Ohio
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Country [13]
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United States of America
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State/province [13]
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Pennsylvania
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Country [14]
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United States of America
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State/province [14]
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Tennessee
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Country [15]
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United States of America
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State/province [15]
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Texas
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Country [16]
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United States of America
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State/province [16]
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Virginia
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Country [17]
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United States of America
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State/province [17]
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Washington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Praxis Precision Medicines
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04832425
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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VP, Clinical Development
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Address
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Praxis Precision Medicines
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04832425
Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
QLD,VIC
Funding & Sponsors
Primary sponsor
Commercial sector/Industry
Primary sponsor name
Praxis Precision Medicines Australia, Pty Ltd
Primary sponsor address
Tower Two Collins Square, Level 36
727 Collins St, Docklands, Vic, 3008
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Public notes
Contacts
Principal investigator
Title
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Prof
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Name
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David Barton
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Address
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1 Beck Court Noble Park, Vic, 3174
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Country
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Australia
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Phone
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+61 3 9546 0009
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Fax
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Email
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[email protected]
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Contact person for public queries
Title
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Dr
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Name
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Bernard Ravina
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Address
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Praxis Precision Medicines One Broadway, 16th Floor Cambridge, MA 02142
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Country
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United States of America
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Phone
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+1 617 300 8460
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Title
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Dr
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Name
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Bernard Ravina
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Address
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Praxis Precision Medicines One Broadway, 16th Floor Cambridge, MA 02142
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Country
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United States of America
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Phone
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+1 617 300 8460
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Fax
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Email
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[email protected]
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