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 info@qcmhr.uq.edu.au or on 07 3271 8704

Cadence Can-Cloz

Cannabidiol (CBD) is a compound that is found in cannabis. CBD is non-psychotropic which means it does not affect perception, mood, or behaviour (unlike THC). In this study, we are trying to determine whether CBD can assist in reducing symptoms for people with schizophrenia or schizoaffective disorder.

Study details:

• 12-week study trial
• Allocated into 1 of 2 groups:
  Active – 1000mg CBD
  Placebo – non-active capsules
• 5 capsules in the evening
• 1x 60-minute research session every 2 weeks
• Phone call follow-ups every other week to monitor for any side effects
• Add-on treatment – this will not affect your current treatment and you will stay on all your regular medications
• Currently taking clozapine for at least 18 weeks
• Blood tests at the beginning, middle and end of the study
•  Option to provide saliva for DNA collection
• Up to $140 in gift vouchers provided throughout study
• All research is completely voluntary. Participants can withdraw from the study at any time.

Inclusion Criteria:

• Aged 18 - 64 years (inclusive)
• Have received oral clozapine for at least 18 weeks
• Diagnosis of schizophrenia or schizoaffective disorder
• Total PANSS score ≥ 60
• Participants must have the capacity to consent and be able to follow the study instructions and procedures (i.e., not under Public Guardian for health matters)
• Participants must be a consumer of a public mental health service in South East QLD

Previous studies have shown that CBD was well tolerated by participants with a mild side-effect profile. Such side effects can include nausea, appetite changes, and fatigue. 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 info@qcmhr.uq.edu.au or on 07 3271 8704

Cadence Discovery

Sodium benzoate is a commonly used food preservative that has been shown to have the potential to reduce overall symptoms of schizophrenia. In this study, we are trying to replicate those results and determine what is the most effective dose to show change.

Study details:

• 6-week study trial
• Allocated into 1 of 4 groups:
  • 1g sodium benzoate
  • 2g sodium benzoate
  • 4g sodium benzoate
  • Placebo (non-active group)
• 4 tablets morning and night
• 1x 60-minute screening session at baseline
• 1x 60-minute research session every 2 weeks
• Phone call follow-ups every other week to monitor for safety
• Add-on treatment – this will not affect your current treatment and you will stay on all your regular medications
• Optional blood test at start and end of study
• Up to $100 in gift vouchers for study completion
• All research is completely voluntary, and you can withdraw from the study at any time.

Inclusion criteria:

• Aged between 18 and 64 years (inclusive)
• Fulfil the DSM-IV criteria for schizophrenia, based on the Diagnostic Interview for Psychosis
• Diagnosis of schizophrenia
• Have a Positive and Negative Syndrome Scale (PANSS) total score ≥60
• Have received antipsychotic medications for a period of at least one continuous month prior to assessment for the study and remained symptomatic despite taking antipsychotic therapy
• Agree to participate, has capacity to consent and is able to follow the study instructions and procedures
• Effective use of contraception (females only)
• Participants must be a consumer of a public mental health service in South East QLD

Previous studies have shown that sodium benzoate was well tolerated by participants with a low side-effect profile. Participants will be monitored by experienced research staff for side effects and can withdraw from the study at any time.

The trial has been reviewed and approved by QIMR Berghofer Research Ethics Committee.

Contact:
For more information please contact us at info@qcmhr.uq.edu.au or on 07 3271 8704