Pharmacogenetic Testing for Mental Health Impairment

1
Effectiveness
1
Safety
University of Calgary, Calgary, Canada
Pharmacogenetic Testing - DiagnosticTest
Eligibility
< 18
All Sexes
Eligible conditions
Mental Health Impairment

Study Summary

This study is evaluating whether pharmacogenetic testing can be implemented in children and adolescents.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Pharmacogenetic Testing will improve 2 primary outcomes and 1 secondary outcome in patients with Mental Health Impairment. Measurement will happen over the course of 6-months.

6-months
Adverse drug reactions
Healthcare utilization
Symptom severity

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Pharmacogenetic Testing

This trial requires 6000 total participants across 2 different treatment groups

This trial involves 2 different treatments. Pharmacogenetic Testing is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Pharmacogenetic Testing
DiagnosticTest
Pharmacogenetic testing panel (CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A5, NUDT15, SLCO1B1, TPMT, VKORC1)
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6-months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6-months for reporting.

Who is running the study

Principal Investigator
C. B.
Prof. Chad Bousman, Associate Professor
University of Calgary

Closest Location

University of Calgary - Calgary, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Medical records available
The initiation, change, dose adjustment, or augmentation of psychiatric medication(s) is indicated
Treating psychiatrist, family physician, or pediatrician licensed in Alberta requests pharmacogenetic testing

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes mental health impairment?

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Mental health impairment in our sample was related to lower socioeconomic status which may be associated with substance misuse. The association of MHI with self-reported recent mental health problems and substance use requires further investigation.

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What are common treatments for mental health impairment?

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Common treatments for mental health impairment include cognitive behavioural therapy, antidepressant medication and/or antidepressant therapy, psychotherapy and/or psychotherapy. There are very few treatments that are specific to the different forms of mental health impairment. However, a more holistic approach that involves all aspects of the individual is necessary for the optimal patient care.

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What are the signs of mental health impairment?

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Some signs of mental health impairment are: a history of being bullied, feeling unsupported by family or friends, being angry or upset for long periods, and/or having lost a job.\n

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Can mental health impairment be cured?

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Symptoms associated with the condition of mental health disturbance can be minimized by providing adequate support in an appropriate setting. But this is not the answer to the question of whether it can be cured.

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How many people get mental health impairment a year in the United States?

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A substantial number of people, who visit their primary care clinics in a year in the United States have mental health issues. Physicians and other health professionals, as well as managers and employers, need to be aware of the mental health of their patients to achieve better reorganization of care, increased continuity, and better outcomes.

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What is mental health impairment?

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An individual can experience various aspects of mental health impairment (MHIP) and show signs of mental illness (MMI). A wide range of mental health disorders can exist, although the most commonly recognised are anxiety and mood disorders. Data from a recent study the majority of people identified with MHIP had some type of mental disorder. In addition, those with MHIP and a history of mental illness were more likely than those without MHIP to seek treatment for recurrent mental health problems, to be prescribed anxiolytics and/or antidepressants and to report mental health symptoms.

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What is pharmacogenetic testing?

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The main aim of pharmacogenetics is the exploration of genetic factors underlying the development of disease. The second aim is to select an individualised regimen based on genetic information and to optimize medication. To date, the genetic basis for the clinical outcome following medical treatment is not well understood. Since all pharmacogenetic tests are focused on identifying genetic variants associated with drug response, clinical applicability of the pharmacogenetic results on particular medicines is yet unclear. A major limitation of the available studies is the number of medications assessed.

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What is the primary cause of mental health impairment?

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Mental health impairment is a complex issue that involves many factors other than primary diagnosis. Primary diagnosis remains a major part of determining patient need. It appears that the primary cause of mental health impairment is a combination of factors. Once the primary cause is recognized, treatments can address the primary problems leading to subsequent improvement of mental health status.

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What is the latest research for mental health impairment?

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The latest research has failed to find many of the same clinical trials that have been conducted in earlier years. However, ongoing clinical research is being conducted in general clinical psychology research trials in patients with mental health impairment (PHI) and evaluating different treatment approaches. Future research should consider [immunological therapy versus nonspecific therapy] to test the immunological mechanisms of symptomatology in patients with MHI.

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Is pharmacogenetic testing typically used in combination with any other treatments?

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Pharmacogenetic testing is most often used in combination with psychotherapy or psychotropic treatment. However, pharmacogenetic testing is most often used as a screening strategy. We found only three studies in our sample that reported the results of pharmacogenetic testing in a patient with mental illness who was not already receiving psychotherapy or pharmacotherapy. Because psychotherapy and pharmacotherapy are often not considered in clinical practice and in the literature, clinicians would benefit from learning more about both procedures and pharmacogenetic tests.

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What are the latest developments in pharmacogenetic testing for therapeutic use?

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Genital herpes is less prevalent in males and the risk of developing genital herpes is lower with the use of valganciclovir than lamivudine/abacavir. Genital herpes is more common in females compared with males and lamivudine/abacavir is superior to valganciclovir in cases of symptomatic genital herpes, thus, the need for new valganciclovir-based regimens in women.

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Have there been other clinical trials involving pharmacogenetic testing?

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In a recent study, findings demonstrate the feasibility and potential utility of conducting pharmacogenetically-based clinical trials. However, it will be important to clarify important details with regard to how to conduct pharmacogenetically-based trials (as in the United Kingdom), how these trials should be planned by specialty societies, and how it would be appropriate to involve patients and their decision-makers in the design of these trials.

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