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Clinical Trials Unit (incorporating Cadence Clinical Trials)

Clinical Trials Unit (incorporating Cadence Clinical Trials)

About the Clinical Trials Unit

Under the leadership of Andrea Baker, the Clinical Trials Unit was originally established as the Cadence Clinical Trials Program out of funding from the John Cade Fellowship to find better treatments for psychotic disorders. Now that the John Cade Fellowship has ended, the Clinical Trials Unit remains dedicated to improving outcomes for people with psychosis, and continues to support QCMHR researchers in the Cadence Clinical Trials program, as well as a range of other clinical studies in collaboration with researchers external to QCMHR.

Overview

Initially funded by the John Cade Fellowship, the Cadence Clinical Trials Program was established to find better treatments for psychotic disorders, linking QCMHR clinical researchers, staff from the Queensland Brain Institute, and clinicians around south-east Queensland to:

  • build a clinical trials platform in South-East Queensland
  • work towards improving clinical outcomes for people with psychosis, particularly early psychosis
  • concentrate on “augmentation” or add-on studies that are pragmatic in design
  • investigate safer and more effective treatments
  • develop introductory clinical trials training to foster the next generation of researchers
Genesis of the program

Professor John McGrath was awarded a John Cade Fellowship in Mental Health Research by the National Health and Medical Research Council (NHMRC) in 2013 (NHMRC grant APP1056929). This five-year grant supported Professor McGrath’s research into modifiable risk factors for schizophrenia.

Most importantly, the Fellowship enabled Professor McGrath and his team to establish the Cadence Clinical Trials platform in South-East Queensland to improve clinical outcomes for people with psychosis, particularly early psychosis.

The first trial, Cadence BZ, commenced in 2015, with other trials following over subsequent years. The program was strengthened by collaborations with the Royal Australian and New Zealand College of Psychiatrists (RANZCP) to build capacity in the next generation of mental health researchers.

The John Cade Fellowship has now come to an end, but the Cadence Clinical Trials team has now morphed into our Clinical Trials Unit, and under Andrea Baker’s leadership, has become QCMHR’s ninth research stream supporting a new generation of clinical trials. It continues to operate under the auspices of the Queensland Centre for Mental Health Research (West Moreton Hospital and Health Service) and the Queensland Brain Institute (The University of Queensland).

QCMHR is immensely grateful for the support of the John Cade Fellowship, which enabled us to establish this clinical trials capability and improve outcomes for people with psychosis long into the future.

what is cadence 768x367 Cadence working group: L to R (floor) Alex Ryan, Andrew Amos, Sue Patterson, Victoria Gore-James, Justin Chapman L to R (back row) Julanne Frater, Kara Forde, Melissa Connell, Ros Cole, Andrea Baker, John McGrath, Anne Gordon, Elinor HIggs, Michael Duhig, Phillip Williams, Saveenah Singh, Victoria Satchwell, Rachel Petro, Alison Bowers, Frances Dark, James Scott, Vinod Raveendran, Michael Berk, Olivia Dean.

Further reading

To find out about other aspects of Professor McGrath’s John Cade Fellowship, for example his vitamin D research, read his article The John Cade Fellowship: Modifiable risk factors for serious mental illness published in the Australian and New Zealand Journal of Psychiatry in 2014.

Cadence BZ Trial

Cadence BZ was the first clinical trial in the Cadence series. The trial aimed to determine if receiving a commonly used food preservative, in addition to regular treatments, assisted with recovery from early psychosis.

The food preservative, sodium benzoate, is commonly used in soft drinks, fruit juices, jams and salad dressings (on labels it is often listed as E211). The US Food and Drug Administration has classified sodium benzoate as “generally recognised as safe” and it is approved in Australia as a food additive. It is also sometimes used to help preserve other medications.

However sodium benzoate is not approved to treat psychosis. Therefore it is an experimental treatment for psychosis, and must be rigorously tested to find out if it is an effective add-on treatment.

Project team

  • Professor John McGrath, Coordinating Principal Investigator, QCMHR
  • Professor James Scott, Principal Investigator, QCMHR
  • Andrea Baker, Study Coordinator, QCMHR
  • Dr Drew Richardson, Associate Investigator, The Prince Charles Hospital
  • Dr Savenna Singh, Associate Investigator, Gold Coast University Hospital
  • Dr Frances Dark, Associate Investigator, Princess Alexandra Hospital
  • Dr Sean Hatherill, Associate Investigator, Logan Hospital
  • Associate Professor Stephen Stathis, Associate Investigator, Queensland Children’s Hospital
  • Dr Sharon Foley, Associate Investigator, Princess Alexandra Hospital
Cadence M

Cadence M was the second clinical trial in the Cadence series*. The trial aimed to determine if receiving an extract from the rind of the tropical fruit mangosteen, in addition to regular treatments, assists with the treatment of schizophrenia.

Mangosteen is a tropical evergreen fruit tree originating in Indonesia. The thick purple rind (pericarp) of the fruit contains a number of compounds called xanthones that show promise in the treatment of schizophrenia.

Many of the most valuable drugs in medicine are plant-derived (e.g. morphine, quinine). Pilot studies suggest that certain xanthones derived from mangosteen pericarp significantly reduce the symptoms of schizophrenia.

The team sought to replicate the results of the pilot study in a larger, multi-site trial.

Project Team

  • Professor Michael Berk, Coordinating Principal Investigator, Deakin University
  • Professor John McGrath, Principal Investigator, QCMHR
  • Andrea Baker, Study Coordinator, QCMHR
  • Professor James Scott, Associate Investigator QCMHR
  • Dr Seetal Dodd, Associate Investigator, University Hospital Geelong
  • Dr Olivia Dean, Associate Investigator, Deakin University
  • Dr Frances Dark, Associate Investigator, Princess Alexandra Hospital

*The Cadence M trial was also known as Mango SZ at our companion site in Geelong.

Cadence M was supported by the Stanley Medical Research Institute.Cadence COMET logo 768x158

Cadence CoMET Trial

Cadence CoMET was the fourth clinical trial in the Cadence series. The CoMET trial examined if starting a diabetes medication called metformin at the same time as the antipsychotic medication clozapine could minimise the weight gain that can occur with clozapine treatment.

Metformin is a commonly used medication for diabetes but is not approved by the Therapeutic Goods Administration (TGA) for weight loss. Previous research however, has found it to promote weight loss in people who have gained weight after clozapine treatment.

People with schizophrenia are known to have a shorter life expectancy due to diseases such as heart disease and diabetes. This is a result of many factors including obesity, poor diet, reduced physical activity and antipsychotic medications. Antipsychotic medications are an essential part of current treatment for schizophrenia and schizoaffective disorder so it is important to examine treatments to target these side effects.

Physical activity programs have been shown to be effective in improving the physical health and weight management for some people taking antipsychotic medications but not all. For this reason it is important to explore other options for improving the physical health of people taking antipsychotic medications.

Project Team

  • Professor Dan Siskind, Coordinating Principal Investigator, Metro South Addiction and Mental Health Service
  • Dr Terry Stedman, Associate Investigator, West Moreton Divison of Mental Health and Specialised Services
  • Associate Professor Anthony Russell, Associate Investigator, Princess Alexandra Hospital
  • Dr Vikas Moudgil, Associate Investigator, Royal Brisbane and Women’s Hospital
  • Dr Savio Sardinha, Associate Investigator, Gold Coast Hospital and Health Service
  • Associate Professor Sue Patterson, Royal Brisbane and Women’s Hospital
  • Andrea Baker, Study Coordinator, QCMHR
Cadence SCIT Trial

The trial aimed to determine if receiving social cognition and interaction training (SCIT) improves psychosocial functioning in people with schizophrenia. The treatment was compared with another type of group therapy that helps people recover from mental disorders.

Functional deficits (i.e. social skill, community functioning) are a core feature of schizophrenia. These deficits are not always improved via medication. While established treatments like social skills training and cognitive remediation improve the specific skills they target, these changes may not help people cope with aspects such as socializing.

Project Team

  • Dr Frances Dark, Coordinating Principal Investigator, Director of Rehabilitation Academic Clinical Unit, Metro South Mental Health Services
Current Clinical Trials
Cadence COaST

Weight gain is a major health problem among people with schizophrenia; there is a lack of effective treatments for obesity in schizophrenia. We are looking for volunteers to determine if receiving a weekly injectable Type-II diabetic medication, semaglutide can assist in reducing the body weight among non-diabetic people taking clozapine.

Study details:
• 36-week single-blind clinical trial
• Weekly injection of semaglutide or placebo (titrated over 20 weeks, i.e., 4 weeks per titrated dose 0.25mg, 0.5mg, 1.0mg, 1.5mg, 2.0mg)
• Physical health measures (blood pressure, heart rate, height, and weight) and assessment of adverse drug reactions
• Validated mental health and psychological clinical measures will be conducted at Baseline, Weeks 20 and 36
• All assessments completed by Cadence Team 
• Adjunct treatment; no restrictions or impact on current treatment
• Semaglutide/placebo trial medication provided at no cost
• Reimbursement: $290 in Coles/Myer gift cards ($50 at baseline, weeks 20 and 36). ($20 at weeks 4, 8, 12, 16, 24, 28 and 32)

Inclusion Criteria:
• Aged 18 - 64 years (inclusive).
• Have received oral clozapine for at least 18 weeks
• Diagnosis of schizophrenia or schizoaffective disorder or bipolar affective disorder
• Not been treated for diabetes or have an abnormal HbA1c/fasting glucose at baseline
• Body weight has not fluctuated by more than ±5% in the previous 3 months
• BMI ≥26
• Participants must have the capacity to consent and be able to follow the study instructions and procedures
• Participants must be a consumer of a public mental health service in South East QLD

Semaglutide will be slowly increased to minimise any side effects but possible side effects of semaglutide include nausea, vomiting, diarrhea and constipation. Participants will be monitored weekly by experienced research staff for side effects.

The trial has been reviewed and approved by Metro South Human Research Ethics Committee.

Contact:
For more information please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it. or on 07 3271 8704

Staff

Andrea Baker

Assistant Director of Nursing Research
Clinical Trials Unit Stream

Adjunct Fellow
PAH-Southside Clinical Unit, The University of Queensland

Visiting Scientist
QIMR Berghofer Medical Research Institute



Peter Cosgrove

Research Officer
Clinical Trials Unit Stream



David Housley

Clinical Research Nurse
Clinical Trials Unit Stream

Industry Fellow
PAH-Southside Clinical Unit, The University of Queensland



Caroline Johnson

Clinical Research Nurse
Clinical Trials Unit Stream

Industry Fellow
PAH-Southside Clinical Unit, The University of Queensland



Michelle Cahill

Research Officer
Clinical Trials Unit Stream

Industry Fellow
School of Public Health, The University of Queensland



Lucinda Burton

Nurse Manager
Clinical Trials Unit Stream

Industry Fellow
School of Public Health, The University of Queensland


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HEAD OFFICE

Level 3, Dawson House
The Park Centre for Mental Health Treatment
Research and Education, Wacol, QLD 4076
P: +61 7 3271 8660

ACKNOWLEDGEMENT OF COUNTRY

In the spirit of reconciliation, the Queensland Centre for Mental Health Research (QCMHR) acknowledges the Traditional Owners of the lands in which QCMHR operates and their continuing connections to land, waters and community. We pay our respects to Elders past and present and stand together with all Aboriginal and Torres Strait Islander peoples.