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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000583347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
9/04/2026
Date registered
Help: Date registered
11/05/2026
Date last updated
Help: Date last updated
11/05/2026
Date data sharing statement initially provided
Help: Data sharing statement date
11/05/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Schizophrenia Platform for Improving Recovery with Integrated Trials (SPIRIT) - Master Protocol
Scientific title
Schizophrenia Platform for Improving Recovery with Integrated Trials (SPIRIT) - Master Protocol for an adaptive platform trial.
Additional trial identifiers [1] 316993 0
Nil
Universal Trial Number (UTN)
Trial acronym
SPIRIT
Related trial records
Cardiometabolic domain: ACTRN12626000530325

Health condition
Health condition(s) studied:
Schizophrenia 341466 0
Condition category
Condition code
Mental Health 337532 337532 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
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.
Intervention code [1] 333741 0
Treatment: Drugs
Intervention code [2] 333742 0
Behaviour
Intervention code [3] 333743 0
Lifestyle
Description of the comparator or control
For this SPIRIT Master protocol, there is no control group. Control groups will be outlined in sub-study records, as they will vary dependent on the sub-study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 345028 0
To determine the optimal set of treatments for addressing physical health issues by people living with schizophrenia
Timepoint [1] 345028 0
Considering this is a platform trial design, the overall trial infrastructure is designed to be perpetual. Outcomes are reviewed on a 6 monthly basis by the trial steering committee.
Primary outcome [2] 345283 0
To determine the optimal set of treatments for addressing mental health issues experiences by people living with schizophrenia
Timepoint [2] 345283 0
Considering this is a platform trial design, the overall trial infrastructure is designed to be perpetual. Outcomes are reviewed on a 6 monthly basis by the trial steering committee.
Secondary outcome [1] 460223 0
NA - secondary outcomes will vary dependent on the sub-study
Timepoint [1] 460223 0
NA - secondary outcomes will vary dependent on the sub-study

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Healthy volunteers
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Randomisation will be conducted at the sub-study level. In general, randomisation will be conducted by an external statistician through a password-protected, secure website using a central, computer-based randomisation program. Randomisation will be at the patient level and occur after data necessary to implement the SPIRIT inclusion and exclusion criteria have been entered into the secure randomisation website. The Response Adaptive Randomisation will occur centrally as part of the computerised randomisation process. Sites will receive the allocation status and will not be informed of the randomisation proportions.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Enrolment in the platform trial will continue until pre-defined decision criteria are met, avoiding indeterminate results often seen in conventional RCTs. This also means that answers to specific questions will be concluded based on the accrued data, rather than pre-specified sample size. As such, SPIRIT is designed as a ‘perpetual trial’ with no pre-defined sample size, the objective of which is to define and continuously update best treatment over the lifetime of SPIRIT.

In addition to informing the response adaptive randomization strategy within each domain, the Bayesian analysis method will be used also to evaluate superiority, inferiority, or equivalence of interventions tested within the platform. Where it is anticipated that interactions between interventions in different domains may be likely, the statistical models will allow evaluation of such interactions. Where the statistical models evaluate such an interaction the models can incorporate the relative likelihood of such interactions.
Each intervention within each domain will be evaluated within prospectively defined and mutually exclusive strata (sub-groups) of participants but information from one stratum may be used (via ‘borrowing’) to contribute to the analysis of the effect of that intervention in other strata. As efficacy data begins to accumulate, probabilities of randomisation are modified to favour more beneficial treatment arms. Interventions that are found to be inferior for a specific stratum will be removed from use in that stratum, and will, typically be removed from SPIRIT allowing new interventions or domains or both to be introduced. This adaptive trial process can be perpetual, substituting new questions as initial ones are answered, allowing a more careful assignment of participants and the simultaneous evaluation of multiple questions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2026
Actual
Date of last participant enrolment
Anticipated
31/12/2029
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
226
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 321589 0
Government body
Name [1] 321589 0
Metro South HHS
Country [1] 321589 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 324392 0
None
Name [1] 324392 0
Address [1] 324392 0
Country [1] 324392 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320116 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 320116 0
Ethics committee country [1] 320116 0
Australia
Date submitted for ethics approval [1] 320116 0
10/11/2023
Approval date [1] 320116 0
29/07/2024
Ethics approval number [1] 320116 0
HREC/2023/QMS/103997

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 149490 0
Prof Dan Siskind
Address 149490 0
Physical and Mental Health Research Group, Queensland Centre for Mental Health Research, Building 33, Princess Alexandra Hospital, Brisbane, 4102
Country 149490 0
Australia
Phone 149490 0
+61 0420680250
Fax 149490 0
Email 149490 0
[email protected]
Contact person for public queries
Name 149491 0
Dan Siskind
Address 149491 0
Physical and Mental Health Research Group, Queensland Centre for Mental Health Research, Building 33, Princess Alexandra Hospital, Brisbane, 4102
Country 149491 0
Australia
Phone 149491 0
+61 07 3176 2111
Fax 149491 0
Email 149491 0
[email protected]
Contact person for scientific queries
Name 149492 0
Dan Siskind
Address 149492 0
Physical and Mental Health Research Group, Queensland Centre for Mental Health Research, Building 33, Princess Alexandra Hospital, Brisbane, 4102
Country 149492 0
Australia
Phone 149492 0
+61 07 3176 2111
Fax 149492 0
Email 149492 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    2025.03.17_SPIRIT_Master Protocol_Clean version 1.2.docx


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.