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Therapeutic Trials Team

Our Therapeutic Trials Team specialises in executing industry-led clinical trials for cutting-edge pharmacological treatments in neuropsychiatric conditions.

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 Under the guidance of both Professor Jayashri Kulkarni and Dr Leo Chen, we have an experienced, multidisciplinary team who are committed towards finding new treatments for Major Depressive Disorders, Schizophrenia and Borderline Personality Disorder.  This team of 20 includes our clinical trials manager, medical practitioners, psychologists, clinical trial coordinators, research nurses and volunteer project officers. We also involve people with lived experience to provide input into study design, and study conduct.

Our expert knowledge and ability is reflected in the first-rate reviews we receive from various clinical trial stakeholders and the positive feedback from trial participants. We continue to foster invaluable partnerships with numerous practicing clinicians and have developed an ongoing participant referral database. We receive consistent positive feedback from our participants who report impressive outcomes, and great enjoyment from their involvement in our research programs.

Explore some of our current projects:

PROJECT 1

Title: A phase II randomized, double-blinded, placebo-controlled parallel group trial to examine the efficacy and safety of 4 oral doses of BI 1358894 once daily over 12-week treatment period in patients with borderline personality disorder.

Principal Investigator: Dr Leonard Chen

Sub Investigators: Prof Jayashri Kulkarni, Dr Lauren Dawes, Anthony de Castella

Study Staff: Dr Eveline Mu, Marta Malicka, Emmy Gavrilidis, Emma Dumigan, Emma Cholakians, Kathleen de Boer

Sponsor: Boehringer Ingelheim Pty Ltd

Primary Aim: The main objectives of this trial were to provide proof of concept (PoC) and dose-ranging data of BI 1358894 compared to placebo in patients with Borderline Personality Disorder to support dose selection for pivotal studies.

Study Updates: The site recruitment target was 5+ and at the conclusion of the trial we screened/consented 17 patients of which 11 were randomised to the study drug, 6 patients were not eligible for the trial and did not proceed and 11 patients completed the study.  

Current status: Trial has ended

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