ANZCTR search results

Rivastigmine (RIV) is an acetylcholine esterase inhibitor which prevents neurotransmitter breakdown. As such it is currently approved for the treatment of neurological disorders such as Alzheimer's and Parkinson's disease. RIV is available in two forms, oral (capsule and liquid) and as a transdermal (through the skin) patch. The latter was developed as a consequence of the oral forms causing nausea, vomiting and diarrhoea predominantly caused by the low oral bioavailability of this drug. Although the transdermal patch overcomes a lot of these side effects, a high percentage of people suffer from skin irritation and possible sleeplessness. This study will investigate whether delivering RIV intranasally (into the nose), results in lower side effects, while maintaining the desired therapeutic effect. As such this study will compare the bioavailability of intranasal delivery to intravenous delivery of RIV at a level that is reported to be therapeutically beneficial. Each intervention will be as a single dose with thorough blood sampling over 24 hours to assess drug levels; each intervention will be separated by a 2 day washout period. This is an exploratory phase 1 trial in 8 healthy elderly males and females aged 55 to 85 years. While comparing the two delivery methods, this study will also investigate the safety and tolerability of intranasal Rivastigmine.

PULSAR stands for ‘Principles Unite Local Services Assisting Recovery’. The overall aim of the PULSAR project is to imbed recovery-oriented practice in primary care and specialist mental health services in the Monash Health catchment. Recovery-oriented practice involves supporting a process of change through which individuals improve their health and wellness, live a self-directed life, and strive to reach their full potential. A training package has been developed in the UK that promotes recovery-oriented practice in teams. We will adapt these materials to needs of the Australian and Victorian mental health care system, the local cultural and legal contexts. The PULSAR intervention involves training staff in recovery-oriented practice using these adapted materials. The current trial pertains to the evaluation of the PULSAR intervention within primary mental health care services; the evaluation of PULSAR in specialist care services is being evaluated in a separately registered trial with ANZCTR. In the primary care trial, we planned to deliver the PULSAR intervention to staff at up to 30 primary care sites (clusters) across the Monash Health catchment area and adjoining Medicare Local regions and evaluate the effect on adult mental health patients of these services. Half of the clusters would be randomised to receive the PULSAR intervention in year one, the other half in year two. Clusters will be separated into similar types of services before randomisation to ensure cluster types are balanced across treatment conditions. Our key hypotheses are that consumers in the PULSAR intervention clusters will experience significantly greater gains in personal recovery, health and wellbeing compared to consumers receiving care in control groups. Data will be collected cross-sectionally from a minimum of 126 consumers at baseline, 9 and 18 months. The total number of participants will be a minimum of 378 consumers. Consumers will be recruited into the study if they respond to an invitation letter by returning a signed consent form and the project questionnaires mailed by their current service on behalf of the researchers. The questionnaires can also be completed online. The above documents the study design as intended to be carried out. However, we did not achieve the intended recruitment targets therefore we adapted the analysis to a pre-post design. This adaptation and final analyses that flow from that are described in the final results paper (see "Study Results"). The significance of the work will be to develop, evaluate, and make readily available a set of training materials and organisational change tools that would facilitate participating mental health services working together to successfully delivery recovery-oriented practice. Embedded qualitative studies explored GP and patient perspectives of recovery-oriented practice and investigated the relevance of the QPR within culturally and linguistically diverse communities.

The aim of this study is to determine the enduring effects on survivorship of an exercise intervention administered in addition to usual care, compared to usual care alone, during first-line chemotherapy for epithelial ovarian, primary peritoneal and fallopian tube cancer. Woman aged 18 years or above, who have been newly diagnosed with epithelial ovarian, primary peritoneal or fallopian tube cancer of any histological type and are suitable for first-line chemotherapy are eligible to participate in this study. Participants are randomly allocated (by chance) to one of two groups. Participants in one group will receive a structured exercise program, in addition to usual care, whilst participants in the other group will receive usual care alone. The structured exercise program will likely include walking and resistance exercise. Participants will be asked to complete questionnaires regarding their physical well-being and quality of life. Participants will be followed for up to 5 years.

This project will involve trialling a multi-component online stress reduction program (Stress eHealth) designed to reduce stress and anxiety and improve mental and physical wellbeing. Those that consent will be randomly allocated to the Stress eHealth program (immediate access group) or a wait control group (delayed access group). The delayed access group will receive the intervention following a 10-week waiting period. Participants randomised to the Stress eHealth (immediate access) group will complete a pre-intervention assessment (Week 0), during intervention (Weeks 1-5) assessment, post-intervention assessment (Week 6) and a 1 and 3 month follow-up assessment (Week 10 & Week 18). Participants randomised to the delayed access group will complete the same assessment phases, except for the 3 month follow-up assessment, as they will be given access to Stress eHealth program following the 1 month follow-up assessment (Week 10). However the delayed access group will be asked to complete the post intervention assessment after they complete the Stress eHealth program (Week 16).

This is an open label study in patients who have been previously treated with intravitreal anti-VEGF drug for DMO and have persisting DMO despite regular injections. The study will describe the effectiveness, safety of intravitreal aflibercept and changes in health-related quality of life (HRQoL) among these patients.

The aim of the I-DECIDE trial is to evaluate an online healthy relationship tool and safety decision aid for women experiencing domestic violence. The study will investigate whether the I-DECIDE intervention can be effectively delivered online, and whether it can overcome some of the barriers encountered in face-to-face interventions. The intervention is designed to provide tailored information, resources, and feedback that enables women to self-inform, self-reflect, and self-manage. It is hypothesised that using I-DECIDE could increase women's self-efficacy and reduce their depressive symptoms when compared to a standard website. Secondarily, it is anticipated that I-DECIDE could increase the number of actions for safety and wellbeing that women engage in and reduce their level of fear while remaining cost-effective.

The aim of this project is to explore the relationship between different emotional states and physical changes in the body such as heart rate, skin temperature, movement levels. Being able to track emotional changes (e.g. anxiety, calmness) within each day along with physical changes (e.g., increased heart rate) will help us to better understand trigger points for health symptoms. With a large amount of emotional and physical data we will be able to begin to identify predictors of changes to well-being, as well as to develop profiles of when someone is beginning to experience a drop in well-being, for example, becoming stressed or anxious.

This will be a single center, open-label, fixed-sequence study to investigate the effects of a single dose of PRN1008 on the PK of midazolam, a CYP3A4 substrate, in healthy participants. One cohort of 12 participants will be studied.

The purpose of the proposed project is to examine the acceptability, efficacy and feasibility of a low-intensity Cognitive Behaviour Therapy (CBT)-based self-management program, the Managing Your Wellbeing Epilepsy Course, in reducing symptoms of anxiety, depression and disability among adults with epilepsy. The Course contains a 5-lesson 8 week CBT program, which can be administered via the internet. Participants will have brief weekly contact with a clinical psychologist as they work through the Course. We expect participants will rate the Course as acceptable and will report that it was worth their time. We also expect that overall sample will make improvements in symptoms of disability, anxiety and depression from pre-treatment to post-treatment, which will be maintained at 3-month.

APL-2 is an experimental drug being developed by Apellis Pharmaceuticals Inc for the potential use as a treatment for people with a broad range of blood disorders (including paroxysmal nocturnal hemoglobinuria (PNH)) and certain types of auto-immune diseases). PNH is caused by a small change to the individual’s genes, which results in red blood cells being broken down prematurely. People with PNH typically feel tired and often see some blood in their urine. The condition is unfortunately progressive with sufferers needing increasing medical care, with an average life expectancy of only 10 years after diagnosis. The currently available treatments are insufficient to deal with this complex disease with most patients not fully responding to the treatments. APL-2 works in a different way to the drugs that are currently approved, and has been shown in animal studies to prevent the breakdown of red blood cells and keep them healthy. It is hoped that APL-2 will help improve the quality of life and reduce the severity of the condition for PNH sufferers. In this study, multiple ascending doses of APL 2 will be assessed in healthy volunteers. The assessments of the safety, tolerability, pharmacokinetics, and pharmacodynamics following administration of single doses of APL-2 will guide decisions to further develop the drug.