None listed
Conditions
Brief summary
Approximately 25% of all medicine is broken down by liver enzymes called CYP2D6 and CYP2C19. In many people these enzymes work more slowly than normal causing particular medicines to accumulate in the body at concentrations higher than intended. In some people these enzymes work too quickly, clearing some medicines before they can work. This type of testing is called precision medicine. Recommendations based on a genetic test may suggest an increase or decrease in medication or that a medicine not be used and that an alternative be prescribed. Numerous genetic studies have shown that a significant number of prescribed medicines are ineffective or cause negative side effects. This study aims to improve the genetic methods used to guide and inform medicine prescriptions. Precision prescriptions may reduce side-effects and increase symptom relief for many individuals. In the main research project, the randomised controlled trial (phase 2) of the Precision Medicine Pathway, we are testing whether genetic testing which determines how well the liver processes medication when given to the participant and their psychiatrist, actually influences any changes in prescribing and in so doing reduces psychiatric symptoms, improves the severity of the illness and quality of life. Understanding a person’s genes may be able to explain why some people respond to a treatment, while others do not, or why some people experience a side effect and others do not. In this second part of the research project we would like to talk to some of the participants, their carers and the research and clinical mental health staff involved in the project to learn whether the genetic information was beneficial or not, and whether there were any barriers or difficulties being involved in the process of the Precision Medicine Pathway including saliva collection, filling in questionnaires, and receiving the information from the genetic testing. We would also be interested in whether any improvements could be made in any of these processes.
Interventions
Pharmacogenetic testing: At baseline participants will provide a saliva sample for DNA testing. Genetic testing of each participant's DNA for the drug-metabolising enzymes CYP2D6 and CYP2C19 will be analysed to predict if the individual is a slow, normal or ultra rapid metaboliser of commonly prescribed antidepressants and antipsychotic medications. A panel of experts, psychiatrists and pharmacologists (CI/AIs) will provide a set of treatment recommendations to the treating psychiatrist at 6 wee
Pharmacogenetic testing: At baseline participants will provide a saliva sample for DNA testing. Genetic testing of each participant's DNA for the drug-metabolising enzymes CYP2D6 and CYP2C19 will be analysed to predict if the individual is a slow, normal or ultra rapid metaboliser of commonly prescribed antidepressants and antipsychotic medications. A panel of experts, psychiatrists and pharmacologists (CI/AIs) will provide a set of treatment recommendations to the treating psychiatrist at 6 weeks after testing. These recommendations could include no change, increase or decrease in dose, or change to alternative medications. Changes to prescribing and adherence to the prescription will be monitored from the hospital, and mental health service medication records and Medicare PBS data. No specific action will be applied to the intervention group to encourage adoption of the recommendations by the doctor and participant or to increase adherence by the participant as the aim is to see if the recommendations alone are acted upon and if so whether they make any difference to clinical and quality of life outcomes. In the qualitative sub-study in the last 6 months of the trial intervention participants, their doctors/psychiatrists, case workers and carers will be asked a series of semi-structured questions taking 20-40 minutes. We will purposefully select the first willing 10 intervention patients varied in gender, age, age at diagnosis and living situation, 3 carers and 10 project and health staff to identify inhibitors and promotors within the health system, affecting uptake of genetic testing and of the prescribing recommendations. Themes will be: related to outcomes ie benefits or otherwise of the testing, and process observations ie the recruitment, ease of understanding of the purpose of testing, the testing itself, receipt of recommendations, clarity of recommendations, barriers and enablers to the process, recommendations for improvement of the process.
Sponsors
Flinders University of South Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Adults with a diagnosis of treatment resistant MDD or SSD, both with or without comorbid disorders confirmed by the MINI interview and are taking prescribed psychotropic medications. Treatment resistance is defined as have trialed 2 or more medications with inadequate treatment response for a minimum of 4 months as determined by the patient and psychiatrist and for those with MDD, PHQ-9 >= 10 and for SDD, each item with a score > 3 on PANSS.
Exclusion criteria
Intellectual or cognitive or language difficulty that prohibits an understanding or participation in the program, active psychosis, severe distress or suicidality, or substance intoxication.
Outcome results
None listed