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Completed

NCT Number: NCT04969510

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

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Praxis Research Site, Noble Park, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

10 mg PRAX-114

Drug

Once daily oral treatment

20 mg PRAX-114

Drug

Once daily oral treatment

40 mg PRAX-114

Drug

Once daily oral treatment

60 mg PRAX-114

Drug

Once daily oral treatment

Placebo

Drug

Once daily oral treatment

Primary outcomes

  1. Change from baseline in 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 outcomes

  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: 4 days, 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: 4 days, 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: 4 days, 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: 4 days, 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: 4 days, 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: 4 days, 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: 4 days, 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: 4 days, 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.

Other outcomes

  1. 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.

  2. Incidence of AEs by preferred term

    Time frame: 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).

  3. Incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) measured suicidal ideation or behavior

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Praxis Precision Medicines

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 20, 2021
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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