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

  • STATUS
    Recruiting
  • End date
    May 31, 2022
  • sponsor
    Praxis Precision Medicines
Updated on 24 May 2021
depressive symptoms
depressed mood
mood disorder

Summary

Praxis Precision Medicines is developing PRAX-114 (the study drug) as a possible new treatment for depression.

Depression is a common but serious mood disorder. It causes severe symptoms that affect how you feel, think, and handle daily activities. Common symptoms of depression can include persistent feelings of sadness and loss of interest in normal day-to-day activities, problems with sleeping, loss of interest in activities, issues with eating or working, and feeling tired, among other symptoms.

GABA (or γ-aminobutyric acid) is a natural chemical in the brain that can slow the way some brain cells work, but that also helps properly balance the activity of groups of brain cells in many parts of the brain. One of many possible causes for depression is that GABA activity in the brain may be too low. PRAX-114 increases the activity of GABA, which might improve the functioning of some brain cells and may help with the symptoms of depression.

The main purpose of this research is to see how well the study drug works for treating depression compared to placebo, as well as its safety and side effects compared with placebo. A placebo is an inactive material that looks like the study drug but does not contain any active drug. Researchers use a placebo to see if the study drug works better or is safer than taking nothing.

An additional purpose of this research is to see if the study drug has effects on specific molecules in your body that may be involved in depression. PRAX-114 is not approved by any regulatory agency, including the United States [US] Food and Drug Administration [FDA], for the treatment of depression.

Description

The use of PRAX-114 in this research is considered experimental. The study drug has been tested in 3 earlier research studies with healthy participants and 1
research study in people with depression. These earlier studies have helped to find doses of PRAX-114 that have few side effects and are fit to test further in depression. This research will find out how well PRAX-114 works and how safe it is in people with depression.

Details
Condition Depression, Depression (Adult and Geriatric)
Clinical Study IdentifierTX274179
SponsorPraxis Precision Medicines
Last Modified on24 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Man or woman ages 18-65 with a diagnosis of recurrent MDD
BMI between 18-38 kg/m2
Current MDE at least 8 weeks but no more than 2 years
Willing to use medically acceptable contraception

Exclusion Criteria

Has demonstrated an inadequate response in the current MDE to a SOC ADT treatment at sufficient dose for at least 6 weeks as document by the ATRQ. ADT that does not meet ATRQ criteria must be discontinued 4 weeks prior to baseline
If subject is doing well on current ADT treatment, it should not be discontinued solely to enter this trial
History of TRD defined as having failed 2 adequate trials of ADT therapy during a MDE with treatments from at least 2 different therapeutic classes. A past history of TRD but demonstrated an ADT response more recently are ok
Ongoing or history of any medical or surgical conditions (including bariatric surgery) that, in the judgement of the PI in consultation with the med mon, may jeopardize safety, interfere with absorption, distribution, metabolism, or excretion
Lifetime history or seizures, including febrile seizures
Has a neurodegenerative disorder (Alzheimer’s, Parkinson’s,MS,Huntington’s)
Poorly controlled diabetes (glucose ≥180mg/100mL or ≥10 mmol/L), has had changes to their diabetic treatment regimen with 30 days, or has had a hospitalization for diabetes/related conditions in the last 6 months
History of cancer
Lifetime history of bipolar disorder, psychotic disorder such as schizophrenia or schizoaffective, OCD, or a history of psychotic mood episode in last 23 years
ECTor VNS within the last year or TMS within the last 6 months
Initiated formal therapy within 4 weeks of screening
Active suicidal thoughts with intent or plan in the last 6 months, or has made a suicide attempt in the past 12 months
Current diagnosis or history of alcohol or substance use disorder within 12 months of screening.Daily consumption of more than 2 alcohol-containing beverages for males and 1 for females
Positive for HIV, Hep B surface antigen or anti-hep C virus antibodies. Participants who have previously recovered from or have been vaccinated for hepatitis may be ok with med monitor approval
Has received an investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to screening
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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