Mental DisorderPGx-SUPPORTNCT06929533
Pharmacogenomics-Supported Psychotropic Prescribing Trial
A study testing Pharmacogenetic Testing in people with Mental Disorder and Pharmacogenetics, run by University of Manitoba at 2 sites in Canada.
Trial summary
Investigate the feasibility and utility of implementing pharmacogenetic testing for adults (aged 18 and older) seeking care for mental illness in Manitoba. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorder, Pharmacogenetics, Adverse Drug Reaction (ADR)
- What is being tested?
- Pharmacogenetic Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jul 2025to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- The initiation, change, dose adjustment, or augmentation of psychotropic medication(s) is indicated
- The treating clinician thinks PGx testing can benefit and refers the patient to the study
Who cannot join
- Unwillingness to donate saliva samples for genetic analysis
- History of liver or bone marrow (hematopoietic cell) transplantation
- PGx testing results are already available
- No personal health identification number (PHIN) is available
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Not yet recruiting
Shared Health Facilities
Winnipeg, Manitoba, R3C 3H8
Abdullah Al Maruf, PhD, M.Pharm, B.Pharm, 204-318-2575, abdullah.maruf@umanitoba.ca
- Recruiting
University of Manitoba College of Pharmacy
Winnipeg, Manitoba, R3E 0T5
Abdullah Al Maruf, PhD, M.Pharm, B.Pharm, 204-318-2575, abdullah.maruf@umanitoba.ca
Mahin Hasan, MSc, BSc, hasanm33@myumanitoba.ca
About this study
Official title: Pharmacogenomics-Supported Psychotropic Prescribing Trial (PGx-SUPPORT): A Pilot Implementation Study in Manitoba
Investigate the feasibility and utility of implementing pharmacogenetic testing for adults (aged 18 and older) seeking care for mental illness in Manitoba.
Read the detailed description
Background and Rationale: Pharmacogenomic (PGx) testing utilizes genetic information as a surrogate marker of a person's ability to process and react to drugs. This information can be used to inform medication selection and dosing, reducing the number of trials needed to choose a suitable medicine. For Manitoba healthcare providers, the only access to psychiatric PGx testing is through commercial providers, costing patients $200 to $2,300. To the best of our knowledge, no study in Manitoba has previously evaluated the feasibility of PGx testing in adult patients seeking care for mental illness.
RESEARCH OBJECTIVES: We aim to investigate the feasibility and utility of implementing PGx testing in Manitoba for adult patients seeking care for mental illness.
Primary Outcome and Measures: Feasibility will be measured along four dimensions:
- Acceptability (satisfaction surveys - patient \& clinician)
- Practicality (testing turnaround time)
- Implementation (clinicians' self-reported use of testing results in the prescribing decision-making process)
- Demand (number of referrals, clinicians' self-reported intent to use testing in the future)
Secondary Outcomes and Measures:
- Changes in global functioning and symptom severity [Clinical Global Impression (CGI) - Severity and Improvement; Brief Psychiatric Rating Scale (BPRS); DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure; Patient Health Questionnaire-9 (PHQ-9); General Anxiety Disorder-7 (GAD-7); Altman Self-Rating Mania Scale (ASRM); Early Psychosis Screener (EPS-26)]
- Adverse drug experience [Frequency, Intensity, Burden of Side Effects Rating (FIBSER)]
- Impact of PGx testing [Changes in medication prescribing and dispensing patterns; changes in healthcare utilization (e.g., inpatient length of stay, mental health resource use, and utilization of healthcare services)
Expected Outcomes: The findings from the proposed study will inform policymakers and facilitate decision-making and priority-setting related to implementing PGx-based psychotropic prescribing policies in Manitoba
- Being tested
- Pharmacogenetic Testing
- Keywords
- Adult, Mental Health, Psychiatry, Pharmacogenetics, Depression, Anxiety, OCD, Psychosis, Bipolar Disorder, mental illness
- Medical subject headings
- Mental Disorders, Drug-Related Side Effects and Adverse Reactions, Psychological Well-Being, Depression, Anxiety Disorders, Psychotic Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenetic TestingDiagnostic test
Participants will donate a 1ml (one-fifth of a teaspoon) sample of saliva. DNA extracted from the saliva sample will be used for genotyping. Genotyping results will be translated into an interpretative clinical report using evidence-based software (Sequence2Script) and delivered to the treating physician for use in their clinical decision-making. The report will contain genotyping results, predicted phenotype, and evidence-based drug selection and dosing recommendations relevant to the patient's current and future care.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacogenetic Testing | Experimental | Pharmacogenetic testing panel (CYP2C19, CYP2D6, CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP4F2, DPYD, HLA-A, HLA-B, NUDT15, SLCO1B1, TPMT, VKORC1, 2C Cluster, UGT1A1) Receives: Diagnostic Test: Pharmacogenetic Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testing Acceptibility
Acceptability will be measured via a four-item patient satisfaction survey three months after the testing and a two-item clinician satisfaction survey after discharge. Responses will be recorded on a five-point Likert scale (1 = very dissatisfied to 5 = very satisfied).
Measured: 3 months after after baseline.
Implementation Practicality
Practicality will be measured by the mean and median testing turnaround time (i.e., test ordering to return of results).
Measured: Up to 3 Months
Implementation Feasibility
Implementation will be measured using a two-item clinician self-report questionnaire that asks about using testing results in the prescribing decision-making process. These will be Yes/No questions, with more "yes" responses indicating higher usefulness and interest in using the test in clinical practice.
Measured: Patient discharge date [within 3 months of baseline].
Test Demands
Demand will be measured by the total number of referrals to the study and by a one-item clinician self-report questionnaire asking about intent to use the testing in the future. Responses will be recorded on a five-point Likert scale (1 = very unlikely to 5 = very likely).
Measured: Patient discharge date [within 3 months of baseline].
Secondary outcomes (10)
Clinical Global Impression Scale (CGI) - Severity
1 = normal, 7 = among the most extremely ill
Measured: Baseline
Clinical Global Impression Scale (CGI) - Improvement
Assesses the overall change in the patient's condition compared to baseline, on a 7-point scale (1 = very much improved, 7 = very much worse).
Measured: 3 months after baseline.
Brief Psychiatric Rating Scale (BPRS)
The rater enters a number for each symptom construct, ranging from 1 (not present) to 7 (extremely severe).
Measured: Baseline and patient discharge date, within 3 months.
DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure - Adult
This adult version of the measure consists of 23 questions that assess 13 psychiatric domains, including depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use. Each item on the measure is rated on a 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearly every day).
Measured: Baseline and 3 months after baseline.
General Anxiety Disorder-7 (GAD-7)
This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21.
0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety
Measured: Baseline and 3 months after baseline.
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 asks patients about the frequency with which they have experienced certain symptoms over the past two weeks, using a four-point scale (0 = "not at all" to 3 = "nearly every day"). The total score, ranging from 0 to 27, indicates the severity of depression, with higher scores suggesting more severe symptoms.
Scoring:
0-4: Minimal or no symptoms 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20 or higher: Severe depression
Measured: Baseline and 3 months after baseline.
Altman Self-Rating Mania Scale (ASRM) - Adult
Each item on the measure is rated on a 5-point scale (i.e., 1 to 5) with the response categories having different anchors depending on the item. The ASRM score range from 5 to 25 with higher scores indicating greater severity of manic symptoms.
Measured: Baseline and 3 months after baseline.
The Early Psychosis Screener (EPS-26)
The EPS-26 consists of 26 questions that assess for symptoms and experiences associated with psychosis. A higher score on the EPS-26 suggests a greater likelihood of being at risk for psychosis.
Measured: Baseline and 3 months after baseline.
Frequency, Intensity, Burden of Side Effects Rating (FIBSER)
It measures three dimensions: the frequency of side effects, the intensity of these side effects, and the burden they impose on daily functioning. Each dimension is rated on a Likert scale, ranging from 0 to 6, where higher scores indicate greater severity and difficulty caused by side effects.
Measured: Baseline (if applicable) and 3 months after baseline.
Healthcare Utlization
Changes in healthcare utilization (including inpatient length of stay) will be measured using a ten-item patient self-report mental health resource use questionnaire, medical charts, and administrative data records six months before and after the participant enrolled in the study.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 Jul 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, Shared Health Manitoba, Winnipeg Regional Health Authority, Health Sciences Centre, Winnipeg, Manitoba
- Responsible party
- Principal investigator, Abdullah Al Maruf, University of Manitoba
- Investigators
- Abdullah Al Maruf, PhD, M.Pharm., B.Pharm, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929533
- Sponsor's protocol ID
- HS26637 (HS2024:279)
- Acronym
- PGx-SUPPORT
- Status last verified
- Sep 2025
- First submitted
- 27 Mar 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics-Supported Psychotropic Prescribing Trial (PGx-SUPPORT): A Pilot Implementation Study in Manitoba
- ClinicalTrials.gov ID
- NCT06929533
- Acronym / sponsor ID
- PGx-SUPPORT / HS26637 (HS2024:279)
- Keywords
- Adult, Mental Health, Psychiatry, Pharmacogenetics, Depression, Anxiety, OCD, Psychosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- University of Calgary, Shared Health Manitoba, Winnipeg Regional Health Authority, Health Sciences Centre, Winnipeg, Manitoba
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate the feasibility and utility of implementing pharmacogenetic testing for adults (aged 18 and older) seeking care for mental illness in Manitoba.
Detailed description
Background and Rationale: Pharmacogenomic (PGx) testing utilizes genetic information as a surrogate marker of a person's ability to process and react to drugs. This information can be used to inform medication selection and dosing, reducing the number of trials needed to choose a suitable medicine. For Manitoba healthcare providers, the only access to psychiatric PGx testing is through commercial providers, costing patients $200 to $2,300. To the best of our knowledge, no study in Manitoba has previously evaluated the feasibility of PGx testing in adult patients seeking care for mental illness.
RESEARCH OBJECTIVES: We aim to investigate the feasibility and utility of implementing PGx testing in Manitoba for adult patients seeking care for mental illness.
Primary Outcome and Measures: Feasibility will be measured along four dimensions:
- Acceptability (satisfaction surveys - patient \& clinician)
- Practicality (testing turnaround time)
- Implementation (clinicians' self-reported use of testing results in the prescribing decision-making process)
- Demand (number of referrals, clinicians' self-reported intent to use testing in the future)
Secondary Outcomes and Measures:
- Changes in global functioning and symptom severity [Clinical Global Impression (CGI) - Severity and Improvement; Brief Psychiatric Rating Scale (BPRS); DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure; Patient Health Questionnaire-9 (PHQ-9); General Anxiety Disorder-7 (GAD-7); Altman Self-Rating Mania Scale (ASRM); Early Psychosis Screener (EPS-26)]
- Adverse drug experience [Frequency, Intensity, Burden of Side Effects Rating (FIBSER)]
- Impact of PGx testing [Changes in medication prescribing and dispensing patterns; changes in healthcare utilization (e.g., inpatient length of stay, mental health resource use, and utilization of healthcare services)
Expected Outcomes: The findings from the proposed study will inform policymakers and facilitate decision-making and priority-setting related to implementing PGx-based psychotropic prescribing policies in Manitoba
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacogenetic Testing | Experimental | Diagnostic Test: Pharmacogenetic TestingPharmacogenetic testing panel (CYP2C19, CYP2D6, CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP4F2, DPYD, HLA-A, HLA-B, NUDT15, SLCO1B1, TPMT, VKORC1, 2C Cluster, UGT1A1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older
- The initiation, change, dose adjustment, or augmentation of psychotropic medication(s) is indicated
- The treating clinician thinks PGx testing can benefit and refers the patient to the study
Key exclusion criteria (4 listed)
- Unwillingness to donate saliva samples for genetic analysis
- History of liver or bone marrow (hematopoietic cell) transplantation
- PGx testing results are already available
- No personal health identification number (PHIN) is available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenetic TestingParticipants will donate a 1ml (one-fifth of a teaspoon) sample of saliva. DNA extracted from the saliva sample will be used for genotyping. Genotyping results will be translated into an interpretative clinical report using evidence-based software (Sequence2Script) and delivered to the treating physician for use in their clinical decision-making. The report will contain genotyping results, predicted phenotype, and evidence-based drug selection and dosing recommendations relevant to the patient's current and future care. | Diagnostic test | Pharmacogenetic Testing |
Primary outcome
Testing Acceptibility
Time frame: 3 months after after baseline.
Acceptability will be measured via a four-item patient satisfaction survey three months after the testing and a two-item clinician satisfaction survey after discharge. Responses will be recorded on a five-point Likert scale (1 = very dissatisfied to 5 = very satisfied).
Implementation Practicality
Time frame: Up to 3 Months
Practicality will be measured by the mean and median testing turnaround time (i.e., test ordering to return of results).
Implementation Feasibility
Time frame: Patient discharge date [within 3 months of baseline].
Implementation will be measured using a two-item clinician self-report questionnaire that asks about using testing results in the prescribing decision-making process. These will be Yes/No questions, with more "yes" responses indicating higher usefulness and interest in using the test in clinical practice.
Test Demands
Time frame: Patient discharge date [within 3 months of baseline].
Demand will be measured by the total number of referrals to the study and by a one-item clinician self-report questionnaire asking about intent to use the testing in the future. Responses will be recorded on a five-point Likert scale (1 = very unlikely to 5 = very likely).
10 secondary outcomes
Clinical Global Impression Scale (CGI) - Severity
Time frame: Baseline
Clinical Global Impression Scale (CGI) - Improvement
Time frame: 3 months after baseline.
Brief Psychiatric Rating Scale (BPRS)
Time frame: Baseline and patient discharge date, within 3 months.
DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure - Adult
Time frame: Baseline and 3 months after baseline.
General Anxiety Disorder-7 (GAD-7)
Time frame: Baseline and 3 months after baseline.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline and 3 months after baseline.
Altman Self-Rating Mania Scale (ASRM) - Adult
Time frame: Baseline and 3 months after baseline.
The Early Psychosis Screener (EPS-26)
Time frame: Baseline and 3 months after baseline.
Frequency, Intensity, Burden of Side Effects Rating (FIBSER)
Time frame: Baseline (if applicable) and 3 months after baseline.
Healthcare Utlization
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abdullah Al Maruf, PhD, M.Pharm., B.Pharm principal investigator
University of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacogenetic Testing in people with Mental Disorder and Pharmacogenetics, run by University of Manitoba at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdullah Al Maruf, BPharm, MPharm, PhD (204-318-2575, abdullah.maruf@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testing Acceptibility (time frame: 3 months after after baseline.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.