Health TrialsbyHealthPanel

Pharmacogenomics-Supported Psychotropic Prescribing Trial

ConditionsMental DisorderPharmacogeneticsAdverse Drug Reaction (ADR)Effectiveness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manitoba

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Pharmacogenetic TestingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
3 months after after baseline.
2

Implementation Practicality

Practicality will be measured by the mean and median testing turnaround time (i.e., test ordering to return of results).

Time frame
Up to 3 Months
3

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.

Time frame
Patient discharge date [within 3 months of baseline].
4

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).

Time frame
Patient discharge date [within 3 months of baseline].

Secondary outcomes

1

Clinical Global Impression Scale (CGI) - Severity

1 = normal, 7 = among the most extremely ill

Time frame
Baseline
2

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).

Time frame
3 months after baseline.
3

Brief Psychiatric Rating Scale (BPRS)

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

Time frame
Baseline and patient discharge date, within 3 months.
4

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).

Time frame
Baseline and 3 months after baseline.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Manitoba

Lead sponsor

University of Calgary

Collaborator

Shared Health Manitoba

Collaborator

Winnipeg Regional Health Authority

Collaborator

Health Sciences Centre, Winnipeg, Manitoba

Collaborator

Source ClinicalTrials.gov
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