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Trial registered on ANZCTR


Registration number
ACTRN12621001368820
Ethics application status
Approved
Date submitted
22/06/2021
Date registered
11/10/2021
Date last updated
24/03/2024
Date data sharing statement initially provided
11/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Towards Implementation of Pharmacogenomics-guided Therapy in Patients with Mental Illness - Stage 2 & Stage 3 (ENACT)
Scientific title
Efficacy in pharmacogenomics in guiding mental health treatment in patients with major depressive disorder and/or anxiety disorders
Secondary ID [1] 304439 0
None
Universal Trial Number (UTN)
Trial acronym
ENACT Stage 2 & Stage 3
Linked study record
This is a follow up study which implements a pilot Model of Care (MOC) developed from Stage 1 (ACTRN12621000739819), involving the use of pharmacogenomics to guide psychotropic pharmacotherapy in patients with Major Depressive Disorder and/or Anxiety Disorders

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 322255 0
Anxiety Disorders 322256 0
Condition category
Condition code
Mental Health 319940 319940 0 0
Depression
Mental Health 319941 319941 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Buccal Swab from the patient is collected after consent, by the treating psychiatrist or study coordinator using a Buccal Swab kit

Intervention: Patient Questionnaires will be completed at Baseline, Weeks 2, 4, 8, 12, 24. Psychiatrists will complete questionnaires at Baseline and Week 12. General Practitioners will complete questionnaires at Week 24.

Intervention: A once only Multi-Disciplinary Team (60 mins) telehealth clinic will occur approximately 2 - 3 weeks after the buccal swab has been taken and when the pharmacogenomics report is ready. This clinic will be attended by the patient, treating psychiatrist, pharmacist, geneticist and genetic counsellor. During the telehealth clinical the pharmacogenomics test report will be reviewed and discussed to determine whether any changes to the patient's current medications are required based on the pharmacogenomics results. The diagnostic report from the laboratory tests 27 genes with high-level evidence covering 24 anti-depressants, 3 anxiolytics and 15 antipsychotics for genetically incompatible medications and drug-gene interations and includes non-CLIA educational material relevant to the genotype of the Study subject.

The strategy used to monitor adherence to the interventions throughout the study is by a checklist kept by the study coordinator with follow up phone calls and emails when required to prompt adherence to interventions
Intervention code [1] 320788 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327812 0
Number of medication changes for each patient from Baseline to Week 12 as defined by dosage alteration, discontinuation of current, and/or initiation of new psychotropic medications. The method of assessment for number and type of medication changes is via a Medication Change Questionnaire for psychotropic medications completed by participants. The questionnaire will record any discontinuation, addition, and dosage alteration of psychotropic medications, as well as reasons for discontinuation.
Timepoint [1] 327812 0
Baseline, Post intervention at Weeks 2, 4, 8, 12 and 24.
Secondary outcome [1] 396679 0
Response rate defined as equal to or greater than 50% decrease in depressive symptoms in patients taking congruent medications versus patients taking incongruent medications as per The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-SR16) score
Timepoint [1] 396679 0
At Week 12 post intervention
Secondary outcome [2] 399907 0
Remission rate defined as equal to or less than a score of 5 as per The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-SR16) score
Timepoint [2] 399907 0
Week 12 post intervention
Secondary outcome [3] 399908 0
Medication Adherence as defined by the validated Three Item Self-Report Measure for Medication Adherence Scale.
To access the Medication Adherence Scale go to Appendix 1 at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5071118/#APP1
Timepoint [3] 399908 0
At Baseline and at weeks 2, 4, 8, 12, 24 post intervention
Secondary outcome [4] 399909 0
Feasibility of the Model of Care for pharmacogenomics guided treatment Model of Care as analysed by an economic evaluation. The economic evaluation is by data linkage to Medicare and PBS data which will include the cost of Pharmacogenomics guided testing, the cost of treatments for pharmacogenomics guided care, cost of medications, and the cost of hospital/emergency room admissions as compared to treatment as usual in the literature.
Timepoint [4] 399909 0
When all patient participants have passed week 24 post intervetion

Eligibility
Key inclusion criteria
1. Aged between 16 years and 70 years inclusive
2. Have a diagnosis of a Major Depressive Disorder (MDD) and/or Anxiety Disorder requiring psychotropic medications (either antidepressants or antipsychotics, or both) as part of their standard care
3. Are either new to psychotropic medication treatment or had psychotropic medication changes in the last three months
4. Sufficiently fluent in English
5. Have both mental and intellectual capacity to provide written or verbal informed consent
6. Willingness to participate in study and complete survey questions
7. Willingness to undergo PG genetic testing
8. Willingness to consider PG-guided psychotropic medication treatment prescribed by treating psychiatrist

Participants with a stable psychotic disorder as a psychiatric comorbidity will not be excluded.
Participants who are receiving other treatment, such as electroconvulsive therapy (ECT) and/or other medications, will not be excluded.
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Significant suicidal risk
2. Mental, cognitive or intellectual impairment interfering with capacity to consent
3. Unwilling to comply with study schedule and requirements




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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/08/2021
Date of last participant enrolment
Anticipated
29/03/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
80
Accrual to date
79
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 19681 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 19682 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 34313 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 308798 0
Other
Name [1] 308798 0
St Vincent’s Health Australia Inclusive Health Program Grant.
Country [1] 308798 0
Australia
Primary sponsor type
Other
Name
St Vincent's Health Australia
Address
Level 22, 100 William Street, Woolloomooloo NSW 2010
Country
Australia
Secondary sponsor category [1] 309714 0
None
Name [1] 309714 0
Address [1] 309714 0
Country [1] 309714 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308713 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 308713 0
95 - 105 Boundary St, Darlinghurst NSW 2010
Ethics committee country [1] 308713 0
Australia
Date submitted for ethics approval [1] 308713 0
03/05/2021
Approval date [1] 308713 0
23/06/2021
Ethics approval number [1] 308713 0

Summary
Brief summary

Stage 2 is a follow up study which implements a pilot Model of Care developed from Stage 1 (ACTRN12621000739819) where participants (n=80) are recruited, and will complete a study period of 24 weeks, with study follow-ups at weeks 2, 4, 8, 12 and 24. Approximately 10-20 psychiatrists, who are involved in the care of patient participants, will be enrolled in the study, to complete online questionnaires. Stage 3 involves economic evaluation of the pilot Model of Care. Approximately 80 GPs, who are involved in the care of patient participants, will be enrolled in the study, to complete online questionnaires. This Model of Care is hypothesised to enhance the feasibility and clinical utility of pharmacogenomics testing to guided pharmacotherapy into routine clinical care of patients with mental illness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111646 0
A/Prof Kathy Wu
Address 111646 0
St Vincent’s Hospital Sydney, Translational Research Centre, 97-105 Boundary Street, Darlinghurst NSW 2010
Country 111646 0
Australia
Phone 111646 0
+610283824899
Fax 111646 0
+610283824895
Email 111646 0
[email protected]
Contact person for public queries
Name 111647 0
A/Prof Kathy Wu
Address 111647 0
St Vincent’s Hospital Sydney, Translational Research Centre, 97-105 Boundary Street, Darlinghurst NSW 2010
Country 111647 0
Australia
Phone 111647 0
+610283824899
Fax 111647 0
+610283824895
Email 111647 0
[email protected]
Contact person for scientific queries
Name 111648 0
A/Prof Kathy Wu
Address 111648 0
St Vincent’s Hospital Sydney, Translational Research Centre, 97-105 Boundary Street, Darlinghurst NSW 2010
Country 111648 0
Australia
Phone 111648 0
+610283824899
Fax 111648 0
+610283824895
Email 111648 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All research data presented will be at group level and will not contain individual participant level data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12948Study protocol  [email protected]



Results publications and other study-related documents

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