None listed
Conditions
Brief summary
An Australian Double-Blind Randomised Controlled Trial of Genotype-guided versus Standard Psychotropic Therapy in People with Treatment Resistant Depression. The study intervention consists of a pharmacogenomic (PG) test with resulting recommendations for which antidepressants may work better for that participant. Eligible participants will be randomised to one of two arms. 1. PG-informed treatment arm: The treatment plan for their antidepressants will be informed by participant’s PG results. 2. Standard treatment arm: The treatment plan for their antidepressants will follow current treatment guidelines but will not be informed by participant’s PG results. Both groups will be recommended medications that follows current treatment guidelines for moderate to severe treatment resistant depression. To test the hypothesis that pharmacogenomic-guided treatment compared to standard treatment improves clinical outcomes in treatment-resistant MDD Study Procedures Pharmacogenetic testing PG-informed or standard care antidepressant treatment Clinical outcome assessments and questionnaires at baseline, and week 2, 4, 12
Interventions
After informed consent, a single DNA sample using a buccal swab kit will be collected from all participants for pharmacogenomic (PG) testing at the Screening Visit.
For participants randomised to the intervention arm, the treatment plan for their antidepressants will be informed by the participant’s PG report - a recommendation for antidepressant prescribing guided by the participants' pharmacogenomic profile in line with TGA recommended doses. The recommendations about antidepressant class an
After informed consent, a single DNA sample using a buccal swab kit will be collected from all participants for pharmacogenomic (PG) testing at the Screening Visit. For participants randomised to the intervention arm, the treatment plan for their antidepressants will be informed by the participant’s PG report - a recommendation for antidepressant prescribing guided by the participants' pharmacogenomic profile in line with TGA recommended doses. The recommendations about antidepressant class and dose are based on Clinical Pharmacogenetics Implementation Consortium (CPIC) and Royal Dutch Pharmacogenetics Working Group (DPWG) international guidelines. All participants will commence treatment within 4 weeks after the Screening visit. Participants will be reviewed at 2, 4 and 12 weeks after treatment initiation (Baseline visit). Participant adherence to antidepressant treatment will be reviewed by the Investigators as per standard of care. In addition the Medication Adherence Report Scale (MARS-5) will be performed. Both groups will be recommended medications that follows current TGA guidelines.
Sponsors
The University of Western 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
- Age 18 - 70 years - Sufficiently fluent in English - Diagnosed with MDD, either first-episode or relapsed, on Mini International Neuropsychiatric Interview (M.I.N.I.) 7.0.2 for DMS-5 criteria - Montgomery and Asberg Depression Rating Scale (MADRS) score of greater than or equal to 20 at Screening and Baseline - Failure of greater than or equal to 2 prior adequate trial of evidenced-based treatments in the current MDD episode - Willing and able to provide informed consent
Exclusion criteria
- Significant suicidal risk based on MADRS and/or M.I.N.I. 7.0.2 for DMS-5 criteria - Substance use disorder not in remission (other than nicotine or caffeine) (as determined during screening DSM5 assessments) - Concurrent psychiatric diagnosis of bipolar disorder, or psychotic disorder (psychotic MDD, schizophrenia, schizoaffective disorder, schizophreniform disorder), or cognitive disorders (intellectual impairment/dementia) (determined by participant medical history or during screening DSM-5 MINI assessment) - Current history of significant hepatic or renal disease affecting drug metabolism. - Pregnant or breast-feeding women
Outcome results
None listed