Recruiting

Pharmacogenetic Testing

Sponsor:

University of Manitoba

Code:

NCT06929533

Conditions

Mental Disorder

Pharmacogenetics

Adverse Drug Reaction (ADR)

Effectiveness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pharmacogenetic Testing

Study Details

Brief summary:

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

Conditions

Mental Disorder

Pharmacogenetics

Adverse Drug Reaction (ADR)

Effectiveness

Study ID

NCT06929533

Start date

Jul 1, 2025

Status verified date

Sep, 2025

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Pharmacogenetic Testing

Pharmacogenetic testing panel (CYP2C19, CYP2D6, CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP4F2, DPYD, HLA-A, HLA-B, NUDT15, SLCO1B1, TPMT, VKORC1, 2C Cluster, UGT1A1)

Interventions

Pharmacogenetic Testing

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 outcome measure

  • Testing Acceptibility [ Time Frame: 3 months after after baseline. ]
  • Implementation Practicality [ Time Frame: Up to 3 Months ]
  • Implementation Feasibility [ Time Frame: Patient discharge date [within 3 months of baseline]. ]
  • Test Demands [ Time Frame: Patient discharge date [within 3 months of baseline]. ]

Central Contacts and Locations

Central contacts

Abdullah Al Maruf, BPharm, MPharm, PhD

204-318-2575abdullah.maruf@umanitoba.ca

Locations

University of Manitoba College of Pharmacy

Recruiting

Winnipeg, Manitoba, Canada, R3E 0T5

Contacts

Abdullah Al Maruf, PhD, M.Pharm, B.Pharm

204-318-2575abdullah.maruf@umanitoba.ca

Mahin Hasan, MSc, BSc

hasanm33@myumanitoba.ca

More Information

Sponsor

University of Manitoba

Last update posted

Sep 8, 2025

Last verified

Sep, 2025

Keywords

  • Adult
  • Mental Health
  • Psychiatry
  • Pharmacogenetics
  • Depression
  • Anxiety
  • OCD
  • Psychosis
  • Bipolar Disorder
  • mental illness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2025-09-08.