Major Depressive DisorderPhase 2NCT04969510
A Clinical Trial of Adjunctive and Monotherapy PRAX-114 in Participants With Major Depressive Disorder
A Phase 2 study testing 10 mg PRAX-114, 20 mg PRAX-114 and 40 mg PRAX-114 in people with Major Depressive Disorder, run by Praxis Precision Medicines at 24 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- 10 mg PRAX-114, 20 mg PRAX-114 and 40 mg PRAX-114
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 24 Jun 2021to 2 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States23 sites
Praxis Research Site
Allentown, Pennsylvania, 18104
Praxis Research Site
Atlanta, Georgia, 30331
Praxis Research Site
Austin, Texas, 78737
Praxis Research Site
Boston, Massachusetts, 02131
Praxis Research Site
Cedarhurst, New York, 11516
Praxis Research Site
Charlottesville, Virginia, 22903
Praxis Research Site
Dayton, Ohio, 45417
Praxis Research Site
Decatur, Georgia, 30030
Praxis Research Site
Everett, Washington, 98201
Praxis Research Site
Gaithersburg, Maryland, 20877
Praxis Research Site
Jacksonville, Florida, 32256
Praxis Research Site
Lafayette, California, 94549
Praxis Research Site
Las Vegas, Nevada, 89102
Praxis Research Site
Lemon Grove, California, 91945
Praxis Research Site
Media, Pennsylvania, 19063
Praxis Research Site
Memphis, Tennessee, 38119
Praxis Research Site
O'Fallon, Missouri, 63368
Praxis Research Site
Oceanside, California, 92056
Praxis Research Site
Orange City, Florida, 32763
Praxis Research Site
Orlando, Florida, 32801
Praxis Research Site
Redlands, California, 92374
Praxis Research Site
Rochester, New York, 14618
Praxis Research Site
Worcester, Massachusetts, 01655
About this study
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
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.
- Conditions
- Major Depressive Disorder
- Being tested
- 10 mg PRAX-114, 20 mg PRAX-114, 40 mg PRAX-114, 60 mg PRAX-114, Placebo
- Keywords
- Mood Disorders, Depressive Disorder, Depression, Depressive Disorder, Unipolar, Depressive Symptoms, Agents, GABA, Receptors, GABA-A, Allosteric Regulation
- Medical subject headings
- Depressive Disorder, Major, Mood Disorders, Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mg PRAX-114Drug
Once daily oral treatment
20 mg PRAX-114Drug
Once daily oral treatment
40 mg PRAX-114Drug
Once daily oral treatment
60 mg PRAX-114Drug
Once daily oral treatment
PlaceboDrug
Once daily oral treatment
| Study group | Role | What they receive |
|---|---|---|
| PRAX-114 (10 mg) | Experimental | 10 mg PRAX-114 once daily Receives: Drug: 10 mg PRAX-114 |
| PRAX-114 (20 mg) | Experimental | 20 mg PRAX-114 once daily Receives: Drug: 20 mg PRAX-114 |
| PRAX-114 (40 mg) | Experimental | 40 mg PRAX-114 once daily Receives: Drug: 40 mg PRAX-114 |
| PRAX-114 (60 mg) | Experimental | 60 mg PRAX-114 once daily Receives: Drug: 60 mg PRAX-114 |
| Placebo | Placebo comparator | Placebo once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days
Secondary outcomes (9)
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.
Measured: 29 days
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.
Measured: 4 days, 8 days, 22 days, 36 days, and 43 days
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).
Measured: 4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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).
Measured: 4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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.
Measured: 4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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.
Measured: 4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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.
Measured: 4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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).
Measured: 4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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.
Measured: 4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start24 Jun 2021
- Primary completion15 Jul 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Praxis Precision Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Executive Director Clinical Development, Study director, Praxis Precision Mediciines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969510
- Sponsor's protocol ID
- PRAX-114-214
- Status last verified
- Aug 2022
- First submitted
- 8 Jul 2021
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04969510
- Acronym / sponsor ID
- PRAX-114-214
- Conditions
- Major Depressive Disorder
- Keywords
- Mood Disorders, Depressive Disorder, Depression, Depressive Disorder, Unipolar, Depressive Symptoms, Agents, GABA, Receptors, GABA-A, Allosteric Regulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Praxis Precision MedicinesIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PRAX-114 (10 mg) | Experimental | Drug: 10 mg PRAX-11410 mg PRAX-114 once daily |
| PRAX-114 (20 mg) | Experimental | Drug: 20 mg PRAX-11420 mg PRAX-114 once daily |
| PRAX-114 (40 mg) | Experimental | Drug: 40 mg PRAX-11440 mg PRAX-114 once daily |
| PRAX-114 (60 mg) | Experimental | Drug: 60 mg PRAX-11460 mg PRAX-114 once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 mg PRAX-114Once daily oral treatment | Drug | PRAX-114 (10 mg) |
| 20 mg PRAX-114Once daily oral treatment | Drug | PRAX-114 (20 mg) |
| 40 mg PRAX-114Once daily oral treatment | Drug | PRAX-114 (40 mg) |
| 60 mg PRAX-114Once daily oral treatment | Drug | PRAX-114 (60 mg) |
| PlaceboOnce daily oral treatment | Drug | Placebo |
Primary outcome
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.
9 secondary outcomes
Change from baseline in HAM-D17 total score at Day 29
Time frame: 29 days
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Executive Director Clinical Development study director
Praxis Precision Mediciines
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10 mg PRAX-114, 20 mg PRAX-114 and 40 mg PRAX-114 in people with Major Depressive Disorder, run by Praxis Precision Medicines at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in HAM-D17 total score at Day 15 (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.