Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000760572
Ethics application status
Approved
Date submitted
20/02/2024
Date registered
20/06/2024
Date last updated
29/10/2024
Date data sharing statement initially provided
20/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Gene-YD – PharmacoGENEtics in Youth Depression
Scientific title
Improving mental health outcomes in Youth: Tailoring antidepressant treatment based on how individual people metabolise medicines using pharmacogenetic testing. Pilot Trial
Secondary ID [1] 311542 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Gene-YD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Youth depression 332896 0
Condition category
Condition code
Mental Health 329614 329614 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Upon obtaining informed consent, DNA sample will be collected from all participants in the form of a buccal swab and a blood sample for pharmacogenetic (PGx) testing at the Screening Visit. Participants who meet the selection criteria, will provide a cheek swab using the YOUTH MIND kit from Gene-S. A blood sample will also be collected, to be analysed by the PathWest laboratory.
For participants who are randomised into the intervention arm, the treatment plan for their antidepressants will be informed by the participant’s PGx report. This report provides recommendations for antidepressant prescribing that are guided by the participant's PGx profile, in accordance with Therapeutic Goods Administration (TGA) recommended doses. The recommendations regarding the class of antidepressant and dosage are based on guidelines from the Clinical Pharmacogenetics Implementation Consortium (CPIC) and the Royal Dutch Pharmacogenetics Working Group (DPWG). The treatment guide will be provided by a psychiatrist from the research team and sent to the participants General Practitioner (GP). Participants in the control group will receive a treatment guide based on the current clinical guidelines, prepared by a psychiatrist on the research team. Both the participant and their GP will be blinded.
Treatment initiation for all participants will occur within four weeks following the Screening Visit. During the Screening Visit, the research team will advise the participant to schedule and appointment with their GP within 1-4 weeks, in which time the PGx report and treatment guide will be prepared and sent to their nominated GP. Reviews of participants will be conducted at 6, and 12 weeks after the initiation of treatment. The adherence of participants to the antidepressant treatment will be reviewed by the Investigators using the Medication Adherence Report Scale (MARS-5).
Medications recommended for both groups will comply with current TGA guidelines.
Intervention code [1] 328000 0
Treatment: Other
Comparator / control treatment
Standard Treatment Arm: The antidepressant treatment plan will adhere to current Therapeutic Goods Administration (TGA) guidelines, without being influenced by the participants' pharmacogenetic (PGx) results.
Control group
Active

Outcomes
Primary outcome [1] 337687 0
The primary outcome of this study is to assess the impact of PGx-guided antidepressant pharmacotherapy on mental health outcomes in young people when compared to standard Australian clinical recommendations. The remission of depressive symptoms is determined by the change in scores for depressive symptoms and the participants' response to antidepressants, defined as > 50% decrease in MADRS scores assessed using the Montgomery and Åsperg Depression Rating Scale.
Timepoint [1] 337687 0
Baseline and 12 weeks after treatment initiation
Primary outcome [2] 338499 0
Another primary outcome of this study is to assess the influence of PGx-guided treatment on the symptomalogy of Major Depressive Disorder (MDD). Changes in MDD symptomology and the symptomology of related mood disorders will be measured by the Quick Inventory of Depressive Symptomatology (QIDS-SR16)
Timepoint [2] 338499 0
Baseline, Week 6 and Week 12 after treatment initiation
Secondary outcome [1] 431743 0
Changes in depression, anxiety, and stress levels. These will be assessed as a composite secondary outcome.
Timepoint [1] 431743 0
Baseline, Week 6 and 12 weeks after treatment initiation
Secondary outcome [2] 431884 0
Changes in quality of life. These will be assessed as a composite secondary outcome.
Timepoint [2] 431884 0
Baseline, Week 6 and 12 weeks after treatment initiation
Secondary outcome [3] 431885 0
Changes in antidepressant side-effect presentation. These will be assessed as a composite secondary outcome.
Timepoint [3] 431885 0
Baseline, Week 6 and 12 weeks after treatment initiation
Secondary outcome [4] 432829 0
Changes in medication adherence. These will be assessed as a composite secondary outcome.
Timepoint [4] 432829 0
Baseline, Week 6 and 12 weeks after treatment initiation
Secondary outcome [5] 432830 0
Changes in participants' relationship with the community. These will be assessed as a composite secondary outcome.
Timepoint [5] 432830 0
Baseline, Week 6 and 12 weeks after treatment initiation
Secondary outcome [6] 432831 0
Changes in work productivity and activity impairment (to be assessed as a composite secondary outcome)
Timepoint [6] 432831 0
Baseline, Week 6 and 12 weeks after treatment initiation
Secondary outcome [7] 436183 0
Participatory experience and participant satisfaction
Timepoint [7] 436183 0
Week 24 after treatment initiation

Eligibility
Key inclusion criteria
Participants may be included in this study if:
1. Participants are aged between 16 to 24 years (inclusive).
2. Participants are able to give informed consent.
3. Participants are fluent in English (to the level of being able to understand the Participant Information and Consent Form and engage with research staff).
4. Participants are diagnosed with major depressive disorder (MDD), either first-episode or relapsed, on Mini International Neuropsychiatric Interview (M.I.N.I.) 7.0.2 for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria.
Minimum age
16 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluding from participating in this study if:
1. Participant displays significant suicidal risk based on Montgomery-Åsberg Depression Rating Scale (MADRS) and/or DSM-V M.I.N.I.
2. Participant displays signs of a substance use disorder not in remission (other than nicotine or caffeine), as determined during DSM-V M.I.N.I. screening assessment.
3. Participant is diagnosed with a concurrent psychiatric diagnosis of any one or more of the following: bipolar disorder, psychotic disorders (psychotic MDD, schizophrenia, schizoaffective disorder, schizophreniform disorder), or cognitive disorders (dementia), as determined by participant medical history or during DSM-V M.I.N.I. screening assessment.
4. Participants have experienced the failure of 2 or more prior adequate trials (at least 6 weeks at a minimum effective dose) of evidenced-based pharmacological treatments, in their current MDD episode.
5. Participant has a history of significant hepatic or renal disease affecting drug metabolism.
6. Participant is a pregnant or breast-feeding woman.
7. Adults (18 – 24 years old) that are not able to provide consent for participation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/08/2024
Actual
16/08/2024
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
18/05/2026
Actual
Sample size
Target
80
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 315839 0
Charities/Societies/Foundations
Name [1] 315839 0
Private philanthropic donation from a single donor family
Country [1] 315839 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Perron Institute for Neurological and Translational Science
Address
Country
Australia
Secondary sponsor category [1] 318011 0
University
Name [1] 318011 0
The University of Western Australia
Address [1] 318011 0
Country [1] 318011 0
Australia
Other collaborator category [1] 282955 0
Commercial sector/Industry
Name [1] 282955 0
Gene-S Pty Ltd
Address [1] 282955 0
Country [1] 282955 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314694 0
North Metropolitan Area Mental Health Services Human Research Ethics Committee
Ethics committee address [1] 314694 0
Ethics committee country [1] 314694 0
Australia
Date submitted for ethics approval [1] 314694 0
26/03/2024
Approval date [1] 314694 0
16/07/2024
Ethics approval number [1] 314694 0
RGS0000006822

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

Contacts
Principal investigator
Name 132418 0
A/Prof Jennifer Rodger
Address 132418 0
Perron Institute for Neurological and Translational Research, Level 1 RR Block QE II Medical Centre Ralph & Patricia Sarich Neuroscience Building, 8 Verdun St, Nedlands WA 6009
Country 132418 0
Australia
Phone 132418 0
+61864882245
Fax 132418 0
Email 132418 0
[email protected]
Contact person for public queries
Name 132419 0
Zahra Cooper
Address 132419 0
Perron Institute for Neurological and Translational Research, Level 1 RR Block QE II Medical Centre Ralph & Patricia Sarich Neuroscience Building, 8 Verdun St, Nedlands WA 6009
Country 132419 0
Australia
Phone 132419 0
+61459261957
Fax 132419 0
Email 132419 0
[email protected]
Contact person for scientific queries
Name 132420 0
Jennifer Rodger
Address 132420 0
Perron Institute for Neurological and Translational Research, Level 1 RR Block QE II Medical Centre Ralph & Patricia Sarich Neuroscience Building, 8 Verdun St, Nedlands WA 6009
Country 132420 0
Australia
Phone 132420 0
+61864882245
Fax 132420 0
Email 132420 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


What supporting documents are/will be available?

No Supporting Document Provided



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.