Psychopharmacology

 

Unit Director

Dr Leo Chen

Leo Chen

Principal Investigators

Dr Leonard Chen

Professor Jayashri Kulkarni

Clinical Trial Coordinators

Stephanie Greco

Navneet Legha

Eveline Mu

Sub Investigators

Dr Kerry McGlynn

Clinical Researchers

Dr Caroline Gurvich

Yukit Mehta

Manager

Anthony de Castella

Ethics / Quality Assurance

Emmy Gavrilidis

Volunteers

Joe Lubman

Current Projects

 

Title: A Randomised, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of High Strength Cranberry (Pacran®) in Women with recurrent Urinary Tract Infections (Cystitis)

Principal Investigator: Prof Jayashri Kulkarni.

Sub Investigators: Dr Leonard Chen

Study Coordinators: Alex Conway, Stephanie Greco, Venu Kulkarni

Sponsor: Swisse Wellness Australia

Brief description: This research study will investigate the effect of daily consumption of a high strength cranberry supplement for the prevention of recurrent UTI in at risk Australian women. High Strength Cranberry is marketed in Australia to help support urinary tract health, but not marketed for the prevention of Recurrent Urinary Tract Infections. Therefore, this clinical trial plans to assess whether it is effective in the prevention of Urinary Tract Infections. It is proposed that the daily consumption of a high strength cranberry supplement will be effective in reducing UTIs in these women, when compared with a placebo control supplement. 300 women with a history of recurrent UTI's will be recruited and randomised to one of two treatment arms (The Cranberry Product or Placebo) and followed up for 6 months to assess whether the study medication reduces the incidence of UTI recurrence. It is proposed that the women who receive the cranberry medication will have a bigger reduction in recurrence of UTI's than the women who receive the placebo


 

Title: A Phase 2 Clinical Trial of PRAX-114 to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy in Participants with Major Depressive Disorder

Principal Investigator: Prof Jayashri Kulkarni.

Sub Investigators: Dr Leonard Chen

Study Staff: Venu Kulkarni, Alex Conway, Stephanie Greco, Caroline Gurvich

Sponsor: Praxis Precision Medicines Australia Pty Ltd

Brief description: This is a clinical trial of PRAX-114 to assess the safety, tolerability, PK, and efficacy in participants with moderate to severe MDD. The clinical trial is comprised of 3 parts:

• Part A is an open-label assessment of a single daily dose of PRAX-114 (up to 120 mg qPM) administered for 7 days inpatient followed by 7 days outpatient to men and women, aged 18 to 65 years, with MDD.

• Part B is an open-label assessment of a single daily dose of PRAX-114 (up to 120 mg qPM) administered for 14 days outpatient to women with perimenopausal MDD.

• Part C is an open-label assessment of a single daily dose of PRAX-114 (up to 120 mg qPM) administered for 27 days outpatient to men and women, aged 18 to 65 years, with MDD.

Part B will only proceed after 12 participants in Part A have completed dosing. The decision to proceed with Part B and/or continue with enrolment in Part A, will be made by the Sponsor in conjunction with the Safety Review Committee (SRC), based on the safety and tolerability data from Part A. Once the safety and tolerability of a given PRAX-114 dose level has been established, Part A may be conducted with additional participants on an outpatient basis similar to Part B but without the perimenopausal population-specific procedures. Part C will be conducted on an outpatient basis using a PRAX-114 dose that has been previously assessed in Part A. Each part of the clinical trial will enrol an independent set of participants.



 

Title: A phase II randomized, double-blinded, placebo-controlled parallel group trial to examine the efficacy and safety of BI 425809 once daily with adjunctive Computerized Cognitive Training over 12 week treatment period in patients with schizophrenia

Principal Investigator: Dr Leonard Chen

Sub Investigators: Prof Jayashri Kulkarni

Study Staff: Venu Kulkarni, Stephanie Greco, Caroline Gurvich

Sponsor: Boehringer Ingelheim Pty Ltd

Brief description: Intact cognition is essential for everyday living. Cognitive impairment is a core feature of schizophrenia. In fact, CIAS has been shown to be a major determinant of poor functional outcome. Thus, treatment of CIAS is a high unmet medical need. Neuroplasticity, which refers to the brain’s ability to acquire and store new information, is activity dependent and responds to environmental demands. Environmental cognitive stimulation conducive to learning is often absent in the lives of patients with schizophrenia. It was hypothesized that efficacy of compounds targeting cognition in patients with schizophrenia may be augmented by providing environmental cognitive stimulatio. Cognitive training employing exercises engaging specific cognitive domains is an optimal tool to provide environmental cognitive stimulation, with more standardized delivery than various in-person psychosocial training. Moreover, cognitive training can be administered outside of the clinic/hospital in a computerized form known as CCT. This training can also be monitored remotely by clinicians to ensure adherence to the training. As a strategy to enhance neuroplasticity and thereby optimize performance of compromised cognitive function in patients with schizophrenia, this study will employ CCT as an enrichment strategy adjunctive to the 12-week treatment with BI 425809. The study is designed to show superiority of BI 425809 over placebo in patients on a background of CCT.



 

Title: A Phase II, 6-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group trial with a quetiapine arm to evaluate the efficacy, tolerability and safety of oral BI 1358894 in patients with Major Depressive Disorder with inadequate response to antidepressants.

Principal Investigator: Dr Leonard Chen

Sub Investigators: Prof Jayashri Kulkarni

Study Staff: Venu Kulkarni, Stephanie Greco, Caroline Gurvich

Sponsor: Boehringer Ingelheim Pty Ltd

Brief description: Despite the array of available treatment options, there remains significant unmet medical need in patients who either do not respond to or do not tolerate current augmentation approaches (e.g., atypical antipsychotics, lithium) or in cases where these are either not available or unsuitable. A product that would show similar efficacy to the above mentioned augmentation treatments, but without the side effects (e.g., weight gain, akathisia, somnolence, abuse potential), would constitute a major medical advance. Based on the pre-clinical data and the data from our proof of clinical principles (PoCP), there is reason to believe that BI 1358894 may be efficacious in treatment of MDD. The underlying hypothesis of the therapeutic concept is that emotion dysregulation is a core symptom of MDD and that a reduction of that symptom will lead to a decrease of the symptom burden related to the depressive symptomatology, including negative valence, anxiety and rumination. If that is achieved, such a treatment approach will lead to a significant improvement in disease burden and an improvement in overall functioning. To address future scientific questions, participants will be asked in this trial to voluntarily donate biospecimens for banking (please see section 5.5). If the participant agrees, banked samples may be used for future biomarker research and drug development projects, e.g. to identify participants that are more likely to benefit from a treatment or less likely to experience an adverse event, or to gain a mechanistic or genetic understanding of drug effects and thereby better match patients with therapies.



 

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

Study Staff: Venu Kulkarni, Stephanie Greco, Caroline Gurvich

Sponsor: Boehringer Ingelheim Pty Ltd

Brief description: This study is designed to provide the proof of concept (PoC) for TRPC4/5 inhibition by BI 1358894 in patients with BoPD and provide data for further development of BI 1358894. There are no qualified biomarkers for BoPD that could be taken as surrogate endpoints or that would be strongly indicative of therapeutic effect. Hence, the PoC can only be achieved in a large, sufficiently powered phase II study to address suitable dose(s), safety and efficacy of BI 1358894, which is the main rationale for this study. Additionally, exploratory biomarkers will be assessed by means of task-based functional magnetic resonance imaging (MRI) measurements (emotional paradigms) for circuit engagement of brain structures involved in emotional processing. These biomarkers of brain physiology may help interpretation of the data, may support the therapeutic concept, or may help identify subgroup of patients that are better responders. The task-based functional MRI sub-study is described in detail in section 10.2. The MRI sub-study will be done at few sites and participation in the sub-study will be optional. In order to be able to address future scientific questions, patients will be asked to voluntarily donate biospecimens for banking (please see section 5.4). If the patient agrees, banked samples may be used for future biomarker research and drug development projects, e.g. to identify patients that are more likely to benefit from a treatment or experience an AE, or to gain a mechanistic or genetic understanding of drug effects and thereby better match patients with therapies.

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

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