None listed
Conditions
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.
Interventions
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
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
Sponsors
St Vincent's Health Australia
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to 70 Years
Healthy volunteers
No
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.
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
Outcome results
None listed