ANZCTR search results

The purpose of this study is to assess the safety, tolerability (how well an individual can tolerate a drug), pharmacokinetics (how a drug moves into, through and out of the body) and pharmacodynamics (the effect of a drug on the body) of single and multiple ascending doses of PLX-4545 in healthy volunteers. PLX-4545 may be indicated for use in patients with cancer that present as solid tumours, but a trial of the drug in healthy volunteers is needed before trials in cancer patients can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 65 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study. Study details This trial will be conducted across three parts. In the first study (Part 1), healthy volunteer participants will be assigned by chance to receive either a single dose of PLX-4545 or placebo, to be taken after a fasting period. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood samples for testing. If the drug appears safe, additional participants will be assigned by chance to receive a larger single dose of PLX-4545 or placebo, followed by blood testing. This will continue until a maximum safe dose is determined. In the second study (Part 2), healthy volunteer participants will be assigned by chance to receive either multiple doses of PLX-4545 or placebo to be taken once per day for 14 days. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood samples for testing. If the drug appears safe, additional participants will be assigned by chance to receive a larger daily dose of PLX-4545 or placebo for 14 days, followed by blood testing. This will continue until a maximum safe dose is determined. In the third study (Part 3), healthy volunteer participants will be assigned by chance to receive either a single dose of PLX-4545 after fasting conditions or immediately after a high fat meal. All participants will have their vital signs checked and will provide blood samples for testing to determine the effect of food on PLX-4545. Once participants have completed their first dose, they will be asked to take another dose either after fasting or a meal, whichever they did not do for the first dose round. It is hoped this research will determine the maximum dose of PLX-4545 that can be administered safely without causing severe reactions. The healthy volunteer study will help define the starting doses of PLX-4545 to be evaluated in a subsequent Phase 1 clinical trial in cancer patients for determining the recommended dose to support a Phase 2 clinical study.

Major depressive disorder (MDD) is a severe and common illness. It has been well established that approximately 30% of patients with MDD have an inadequate response to standard medication and psychological therapies. These patients remain disabled for long time as treatment options are limited. Current brain stimulation treatment options for MDD are costly and can be inconvenient as they may require daily trips to clinics for long treatment sessions that happen over the course of 6 weeks or more. Additionally, we are technically constrained in what we can achieve and current technologies and approach to treat MDD have generally used a ‘one size fits all’ method. Transcranial alternating current stimulation (tACS) is a novel, non-invasive brain stimulation method that delivers a weak electrical current to the brain and is able to modulate brain oscillatory activity. tACS has potential to change the lives of patients with MDD by specifically targeting brain circuits and oscillations relevant to MDD. Our approach aims to change the ‘one size fits all’ method by conducting a proof-of-concept study demonstrating the feasibility, clinical and electrophysiological impact of closed-loop theta tACS. The study will specifically aim to confirm whether theta oscillations and mood in patients with MDD can be successfully modulated by tACS. We hypothesize that a series of personalized theta tACS sessions applied to the dorsolateral prefrontal cortex (DLPFC) in patients with depression can modulate the following to a greater degree in participants who are receiving active treatment compared to sham stimulation: 1. Modulate theta activity at rest and during cognitive tasks (measured using EEG) on and emotional Stroop task and a working memory task 2. Modulate behavioral performance on both the emotional Stroop and working memory tasks. 3. Modulate depression symptoms (clinician rated and self-reported).

Major depressive disorder (MDD) is a severe and common illness. It has been well established that approximately 30% of patients with MDD have an inadequate response to standard medication and psychological therapies. These patients remain disabled for long time as treatment options are limited. Current brain stimulation treatment options for MDD are costly and can be inconvenient as they may require daily trips to clinics for long treatment sessions that happen over the course of 6 weeks or more. Additionally, we are technically constrained in what we can achieve and current technologies and approach to treat MDD have generally used a ‘one size fits all’ method. Transcranial alternating current stimulation (tACS) is a novel, non-invasive brain stimulation method that delivers a weak electrical current to the brain and is able to modulate brain oscillatory activity. tACS has potential to change the lives of patients with MDD by specifically targeting brain circuits and oscillations relevant to MDD. Our approach aims to change the ‘one size fits all’ method by conducting a proof-of-concept study demonstrating the feasibility, clinical and electrophysiological impact of closed-loop theta tACS. The study will specifically aim to confirm whether theta oscillations and mood in patients with MDD can be successfully modulated by tACS. We hypothesize that a series of personalized theta tACS sessions applied to the dorsolateral prefrontal cortex (DLPFC) in patients with depression can modulate depression symptoms (clinician rated and self-reported). We also hypothesize that the tACS treatment will be well tolerated by participants.

Substance use disorders (SUDs) pose a major public health concern. While initial research suggests that physical activity (PA) might benefit individuals in SUD treatment, we still lack definitive evidence. High relapse rates, comorbidity, and motivation challenges among SUD patients often hinder PA interventions. In this study, we will assess the impact and practicality of a motivational program to boost PA motivation and maintenance among residents with SUDs in a Western Australian treatment facility. The study will span over 28 weeks, including baseline (six weeks), intervention (ten weeks), and maintenance (twelve weeks) periods. We will use daily assessments to track PA motivation, substance use cravings, and emotional state. Thereby, we will explore how the intervention may influence these variables change across the study phases. These findings may guide future research and help apply successful PA interventions to broader SUD populations.

This study will assess the safety and immune response to GPV381. Participants will be admitted as day patients to the unit and receive a dose of IP on Day 1 and remain in the unit for 4 hours post dose for tests and observations. They will be discharged following assessments and return for an outpatient visit on Day 8. They will be readmitted as a day patient for a second and third dose on Day 28 and Day 56, respectively, and return for outpatient safety assessments on Days 35 and 63, and for longer-term safety and immunogenicity follow up visits on Day 90 and Day 120.

This study will provide a course of schema therapy to adults with eating disorders featuring binge-eating. The treatment will be tailored to certain aspects of personality: early maladaptive schemas, perceived parenting style and temperament. The aim of the study is to determine whether this treatment reduces eating disorder symptoms and behaviours and whether there is a relationship between change in early maladaptive schemas and eating disorder symptoms. People aged 18 or older with eating disorders featuring binge eating (e.g., bulimia nervosa, binge eating disorder) will be eligible to participate in the study. The study will be conducted at multiple sites, including two eating disorder services in the UK and three private practice centres in Australia. The treatment includes 25 x 1-hour sessions over approximately 30 weeks. Participants will complete questionnaire measures before starting treatment, halfway through treatment, at the end of treatment and at 3- and 6-months after treatment is complete. To understand participants' perspective of the treatment, an optional qualitative interview will be conducted after treatment is complete.

The Lily Registry will aim to: a. collect data about inpatients with medical complications of eating disorders b. define the practice and improve outcomes for patients with medical complications of eating disorders c. encourage translational research, innovation, and clinical leadership in best practice care across South Australia for this important and challenging patient cohort d. enable excellence in inpatient care of people with medical complications of eating disorders by supporting best-practice multidisciplinary care and continuous quality improvement

Blood vessel disease is linked with risk of dementia, cardiovascular disease and falls. A large clinical trial will determine if a novel, low-cost, behaviour change program (knowledge of level of blood vessel disease, its links with risk of dementia, cardiovascular disease and falls, and the benefits of and how to follow a Mediterranean diet) will motivate an individual to make healthy lifestyle changes and will improve measures of risk for dementia, cardiovascular disease and falls. The study hypothesis is that adherence to the MedDiet will be improved after provision of the behaviour change program.

The overarching goal of this research is to improve the efficacy of exposure by optimising a digital exposure-focused intervention (the Courage Quest intervention). This intervention (named Courage Quest Plus) is for children aged 8 to 12 years with one or more anxiety disorders. We are aiming to answer the following research question: Testing Courage Quest Plus. What is the optimal method of delivery of exposure? More specifically, what are the key features that optimise outcomes of exposure, i.e., lead to greatest reductions in anxiety symptoms and remission of anxiety and related disorders, as conducted via the Courage Quest Plus intervention, in children aged 8 to 12 years. We aim to evaluate this through using a fractional factorial design. Although we cannot test all optimization features in one study, we will test 5 features based on the literature in a fractional factorial design, i.e., i) expectancy violation, ii) positive affect, iii) parent training, iv) relaxation, and v) rewards. We hypothesise that the optimal intervention includes expectancy violation, positive affect, parent training, and attachment-based rewards, and does not include relaxation.

This project investigates how low and moderate doses of alcohol affects eye movement patterns during driving. It will also examine how these doses of alcohol affects cognition, visual information processing, and subjective intoxication. It is hypothesised that eye tracking methods will show good sensitivity and reliability for detecting impairment due to alcohol usage during actual driving.