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NCT Number: NCT06929533

Pharmacogenomics-Supported Psychotropic Prescribing Trial

Investigate the feasibility and utility of implementing pharmacogenetic testing for adults (aged 18 and older) seeking care for mental illness in Manitoba.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shared Health Facilities, Winnipeg, Manitoba, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Pharmacogenetic Testing

Diagnostic 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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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).

Secondary outcomes

  1. Clinical Global Impression Scale (CGI) - Severity

    Time frame: Baseline

    1 = normal, 7 = among the most extremely ill

  2. Clinical Global Impression Scale (CGI) - Improvement

    Time frame: 3 months after baseline.

    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).

  3. Brief Psychiatric Rating Scale (BPRS)

    Time frame: Baseline and patient discharge date, within 3 months.

    The rater enters a number for each symptom construct, ranging from 1 (not present) to 7 (extremely severe).

  4. DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure - Adult

    Time frame: Baseline and 3 months after baseline.

    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).

  5. General Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline and 3 months after baseline.

    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

  6. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline and 3 months after baseline.

    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

  7. Altman Self-Rating Mania Scale (ASRM) - Adult

    Time frame: Baseline and 3 months after baseline.

    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.

  8. The Early Psychosis Screener (EPS-26)

    Time frame: Baseline and 3 months after baseline.

    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.

  9. Frequency, Intensity, Burden of Side Effects Rating (FIBSER)

    Time frame: Baseline (if applicable) and 3 months after baseline.

    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.

  10. Healthcare Utlization

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdullah Al Maruf, BPharm, MPharm, PhD

CONTACT

[email protected]

204-318-2575

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Health Sciences Centre, Winnipeg, Manitoba
  • Shared Health Manitoba
  • University of Calgary
  • Winnipeg Regional Health Authority

Registry information

Official study title

Pharmacogenomics-Supported Psychotropic Prescribing Trial (PGx-SUPPORT): A Pilot Implementation Study in Manitoba

Acronym: PGx-SUPPORT

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Apr 16, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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