Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06929533

Pharmacogenomics-Supported Psychotropic Prescribing Trial: A Pilot Implementation Study in Manitoba

Led by University of Manitoba · Updated on 2025-09-08

200

Participants Needed

2

Research Sites

104 weeks

Total Duration

On this page

Sponsors

U

University of Manitoba

Lead Sponsor

U

University of Calgary

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the feasibility and usefulness of pharmacogenetic (PGx) testing for adults aged 18 and older seeking care for mental illness in Manitoba. PGx testing uses genetic information to guide medication selection and dosing, potentially reducing the trial-and-error process when prescribing psychotropic medicines. This study aims to explore how well PGx testing can be integrated into mental health care and its impact on clinical decisions and patient outcomes in this population. Participants will undergo pharmacogenetic testing by providing a small saliva sample. The extracted DNA is analyzed for specific gene variants related to drug metabolism and response. Results are compiled into a detailed clinical report with evidence-based recommendations to help physicians tailor psychotropic medication choices. This testing panel includes multiple genes such as CYP2C19, CYP2D6, and others relevant to psychiatric drug response, and results are shared with treating clinicians to inform treatment decisions. During the study, participants and clinicians will complete satisfaction surveys, and researchers will track test turnaround times and how results affect prescribing patterns. Various clinical assessments, including symptom severity and global functioning scales, will be performed at baseline and up to three months after to evaluate changes. Additional measures include adverse drug reaction ratings and healthcare resource use over one year. The study seeks to inform healthcare policy and support decisions on implementing PGx-guided psychotropic prescribing in Manitoba.

CONDITIONS

Brief Title

Pharmacogenomics-Supported Psychotropic Prescribing Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Psychotropic medication initiation, change, dose adjustment, or augmentation is indicated
  • Treating clinician believes PGx testing may benefit and refers the patient to the study
Not Eligible

You will not qualify if you...

  • Unwilling to provide saliva samples for genetic testing
  • History of liver or bone marrow transplantation
  • Pharmacogenetic testing results already available
  • No personal health identification number (PHIN) available

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Pharmacogenetic Testing

Duration - Up to 3 months

Participants provide a saliva sample for genetic testing to help guide medication selection and dosing.

1 baseline visit

Follow-up and Assessment

Duration - 3 months

Participants are assessed for clinical symptoms, medication side effects, and healthcare utilization over time to evaluate the impact of pharmacogenetic testing.

1 follow-up visit approximately 3 months after baseline

Trial Site Locations

Total: 2 locations

1

Shared Health Facilities

Winnipeg, Manitoba, Canada, R3C 3H8

Not Yet Recruiting

2

University of Manitoba College of Pharmacy

Winnipeg, Manitoba, Canada, R3E 0T5

Actively Recruiting

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Research Team

A

Abdullah Al Maruf, BPharm, MPharm, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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