None listed
Conditions
Brief summary
With traditional randomised controlled trials (RCTs) generation of evidence is inefficient, facing high costs and lengthy set-up times. Traditional RCTs also encounter recruitment challenges and are restricted to answering only one specific question about one single intervention resulting in limited insights and slower evidence generation to enhance consumer outcomes. To develop more effective treatments and improve the speed, cost and number of randomised evaluations of promising treatments for schizophrenia, the Schizophrenia Platform for Improving Recovery with Integrated Trials (SPIRIT), underpinned by the current Master protocol, will use innovative trial design and statistical methods to evaluate multiple treatments simultaneously, improving affordability, speed, and applicability. By streamlining infrastructure setup and utilising comparator information, it will require fewer participants and adapt to new treatments as they become available and increase the likelihood of beneficial treatment.
Interventions
The four domains of SPIRIT are:
1. Cardiometabolic (e.g. subcutaneous Tirzepatide);
2. Lifestyle and social functioning domain (e.g. exercise interventions);
3. Psychosis domain (e.g. augmentation agents for psychosis); and,
4. Cognition domain (e.g. behavioural interventions to improve cognition).
Investigational products/interventions will be identified via a pharmacy-epidemiology and pre-clinical pipeline, and will be determined by the SPIRIT trial steering committee (meetings are every 6 mo
The four domains of SPIRIT are: 1. Cardiometabolic (e.g. subcutaneous Tirzepatide); 2. Lifestyle and social functioning domain (e.g. exercise interventions); 3. Psychosis domain (e.g. augmentation agents for psychosis); and, 4. Cognition domain (e.g. behavioural interventions to improve cognition). Investigational products/interventions will be identified via a pharmacy-epidemiology and pre-clinical pipeline, and will be determined by the SPIRIT trial steering committee (meetings are every 6 months). Monitoring meetings for SPIRIT will be held every 6 months to discuss new arms/stopping ineffective arms (if appropriate) The platform trial is designed to run in perpetuity, with specific disease arms and domains each having explicit inclusion criteria based on the study-specific characteristics.
Sponsors
University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria for the SPIRIT platform: 1. Aged between 18 and 64 years (inclusive). 2. Fulfil the DSM-V criteria for schizophrenia or schizoaffective disorder, based on the Structured Clinical Interview for DSM-5 (SCID-5). 3. Agree to participate and have capacity to consent and able to follow the study instructions and procedures. Note that specific sub-study inclusion criteria is provided in the relevant sub-studies.
Exclusion criteria
1. Any concomitant disease or condition that according to the investigator’s assessment makes the patients unsuitable for platform trial participation. 2. Inability to follow the study instructions and procedures. 3. People who are unable to understand or communicate in English. Note that specific sub-study exclusion criteria is provided in the relevant sub-studies.
Outcome results
None listed