PRAX-114 Research Study in Major Depressive Disorder

Background:

The Monash Alfred Psychiatry research centre (MAPrc), based at the Alfred Hospital is currently recruiting women suffering with peri-menopausal Major Depressive Disorder to participate in a clinical trial.

Major Depressive Disorder is a common but serious mood disorder. It causes severe symptoms that affect how you feel, think, and handle daily activities. Typically, it manifests as persistent feelings of sadness and loss of interest in normal day to day activities, often with symptoms such as disturbed sleeping, loss of interest in eating, or working.

The new treatment is called PRAX-114. PRAX-114 works by increasing the activity of GABA. GABA is a natural chemical in all brains that acts to decrease the function of some cells. One possible cause for depression is that GABA activity in the brain is too low.

MAPrc is currently recruiting for two parts of the study, Part A, and Part B. You can only participate in one of the two parts and your eligibility for either part will be determined by your study doctor.

Aim:

Primary Aim: To test the hypothesis that increasing GAPA receptor neurotransmission, following an oral dose of PRAX-114, can provide therapeutic benefit to patients with MDD.

Secondary Aim: To assess the efficacy of PRAX-114 as an adjunctive antidepressant to standard of care in participants with MDD 

Participants:

Males and Females (between the ages of 18 and 65 years) with Major Depressive Disorder diagnosis without psychosis are invited to take part in this study.

Methods:

Before you begin the research study, we will give you detailed information about the research, study drug, and any other relevant information for participating int his research study. We encourage you to ask questions until you are sure that you fully understand the nature and the requirements.

This study has three parts, Part A, Part B, and Part C. You can only participate in one of the three parts, and your eligibility will be determined by your study doctor. At the moment, MAPrc are only recruiting participants for Part B and Part C.

  • Part B: Up to 24 participants (female with perimenopausal MDD), 14 oral doses of PRAX-114 up to 120 mg once every day (14 days outpatient). 


  • Part C: Up to 12 participants (male and female with MDD), 27 daily doses of PRAX-114 up to 120 mg once every day (27 days outpatient).

This study is open label which means that you will know which dose of study drug you are receiving, and the researchers will know as well. Part B will last about 6 weeks with a total of up to 6 visits. Part C will last about 8 weeks with a total of up to 8 visits. 

Project status

We are currently recruiting for both Part B and Part C.

For more information, please contact our team via email participate.maprc@monash.edu , or call 03 9076 6564.

 

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 MAPrc Monash Alfred Psychiatry Research Centre, Level 4, 607 St Kilda Road, Melbourne 3004

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