The second round of recruitment is underway for the Phase 2a trial led by Brisbane-located Queensland University of Technology (QUT).
This trial has already involved 32 people who experience depression and more volunteers are being sought as QUT and Medlab aim for estimated total participant numbers of 150.
Depression a global issue
The Phase 2a trial has been designed to meet TGA requirements for expedited drug approval.
Globally, more than 300 million people suffer from depression and in Australia, 45% of people aged 16-85 years have met the criteria for a diagnosis of a mental disorder at some point in their lives.
Depression, as a part of mental health, is an Australian health priority.
Principal investigator of the trial, clinical psychologist Dr Esben Strodl from QUT’s Institute of Health and Biomedical Innovation, said the study had made good progress with recruitment to date.
“With the start of a new year, a new recruitment phase is being launched with optimism of meeting recruitment targets on time.
“The research team is pleased with the current progress and outcomes of the study,” he said.
Since 30% of people with depression do not respond to medication, the trial is seeking to show that improving gut health with NRGBiotic™ will make standard depression medicine more effective.
Research corroborates direction
New research just published in Nature Microbiology, from a data sample of 2,000 people in Europe, shows certain strains of bacteria in the gut are depleted in people with depression.
This adds to mounting evidence of an association between gut health and the brain and corroborates earlier research by Medlab and results from its successful Phase 1 trials of NRGBiotic™.
“On the right track”
Medlab managing director Dr Sean Hall said the combination of trial expansion and recently published European research showed “we have been, and still are, on the right track.
“NRGBiotic™ (patented) is available from pharmacies so we have substantial anecdotal evidence of its positive effects but we’re taking the clinical trial route to provide scientific validation and a drug pathway.”
Dr Strodl’s co-investigators are Dr Matthew Bambling, from University of Queensland’s Faculty of Medicine, and Medlab medical director Professor Luis Vitetta.
“Great interest” in recruitment
Dr Bambling said: “Recruitment has gone very well, with great interest from the public and professions alike.
“We continuously receive enquiries from potential participants who are looking for new treatments for their depression.”
Medlab Clinical, an Australian-based medical life science company, is developing therapeutic pathways for diagnosed chronic diseases.
It is advanced in developing therapies for pain management, depression and obesity as well as earning revenue from the sale of nutritional products in Australia and the United States.
In pain management, Medlab is developing cannabis-based medicines.
The Medlab developed nano-particle medicine delivery system, Nanocelle™, is being applied to its medicines, nutritional products and off-patent drugs like statins.