Pharmacogenomics-Supported Psychotropic Prescribing Trial

NCT06929533 | Recruiting

• 1 other identifier: HS26637 (HS2024:279)
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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.

  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).

  Patient discharge date [within 3 months of baseline].

Secondary Outcomes (10)

• Clinical Global Impression Scale (CGI) - Severity

  Baseline

• Clinical Global Impression Scale (CGI) - Improvement

  3 months after baseline.

• Brief Psychiatric Rating Scale (BPRS)

  Baseline and patient discharge date, within 3 months.

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

  Baseline and 3 months after baseline.

• General Anxiety Disorder-7 (GAD-7)

  Baseline and 3 months after baseline.

Study Arms (1)

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)

Diagnostic Test: Pharmacogenetic Testing

Interventions

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.

Pharmacogenetic Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Shared Health Facilities

Winnipeg, Manitoba, R3C 3H8, Canada

NOT YET RECRUITING

University of Manitoba College of Pharmacy

Winnipeg, Manitoba, R3E 0T5, Canada

RECRUITING

MeSH Terms

Conditions

Mental Disorders; Drug-Related Side Effects and Adverse Reactions; Psychological Well-Being; Depression; Anxiety Disorders; Psychotic Disorders; Bipolar Disorder

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Personal Satisfaction; Behavior; Behavioral Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

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

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdullah Al Maruf, BPharm, MPharm, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 16, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)