Genetic Counseling for Mental Health Risks Associated with Cannabis Use

(IMAGINE Trial)

Overseen By Rudolf Uher, MD, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Psychotic disorder, Bipolar, Severe depression, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether genetic counseling can help people understand their risk of developing severe mental illnesses linked to cannabis use. Participants will receive personalized advice from a genetic counselor, who will discuss their risk based on family history, cannabis use, and genetic factors. The goal is to determine if this information encourages them to reduce or avoid cannabis use. The trial suits individuals aged 12 to 21 who are part of the FORBOW study, speak English, and do not already have a severe mental illness.

As an unphased trial, this study offers participants the opportunity to gain valuable insights into their genetic risks and make informed health decisions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this genetic counselling is safe?

Research has shown that genetic counseling is safe for participants. This process involves discussing genetic information with a trained professional to understand health risks. It does not include taking medicine or undergoing physical procedures, so no side effects are known from the counseling itself.

In previous studies, individuals who received genetic counseling to learn about their genetic risk for mental health issues reported no harm or negative effects from the sessions. The main goal of this counseling is to educate and inform, helping individuals make better choices, such as reducing cannabis use if they are at higher risk for mental health issues.

Overall, genetic counseling is well-received and poses no safety concerns for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about genetic counseling for mental health risks associated with cannabis use because it offers a personalized approach to understanding mental health risks. Unlike standard treatments that might not consider an individual's genetic makeup, this method provides participants with insights into their specific genetic predispositions. By receiving tailored information about their genotype, family history, and cannabis use, individuals can make more informed decisions about their mental health. This personalized counseling could lead to better prevention strategies for severe mental illnesses (SMI), ultimately improving patient outcomes.

What evidence suggests that genetic counselling is effective for reducing cannabis use?

In this trial, participants will receive genetic counseling, which studies have shown may help reduce cannabis use among young people at risk of severe mental illness (SMI). Research indicates that individuals with certain genetic traits, such as the AKT1 rs2494732 gene, are up to seven times more likely to develop schizophrenia if they use cannabis. By learning about these genetic risks through counseling, individuals may choose to avoid cannabis, thereby lowering their risk of developing SMI. This approach relies on the idea that understanding genetic risk can lead to better decisions about cannabis use, a controllable risk factor. While researchers continue to study the exact effectiveness of this counseling, early results are promising for reducing cannabis use and potentially preventing SMI. Participants in the control group will not receive this intervention and will continue with their standard care. ^{1 2 5 6 7}

Who Is on the Research Team?

Rudolf Uher, MD

Principal Investigator

Nova Scotia Health Authority, Dalhousie University

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals aged 12-21 who are part of the FORBOW study, can consent to future contact, and have the capacity to give informed consent. It excludes those with severe mental illness, autism, or intellectual disability (IQ < 70).

Inclusion Criteria

Knowledge of English sufficient to benefit from the intervention.

I was able to understand and agree to the study's requirements recently.

Enrolment in the Families Overcoming Risks and Building Opportunities for Well-being (FORBOW) study.

Exclusion Criteria

Your intellectual disability is severe enough that it affects your ability to be assessed (IQ score below 70).

I have been diagnosed with a severe mental illness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genetic Counselling Intervention

Participants receive genetic counselling regarding their personalized risk of developing SMI based on genotype, family history, and cannabis use. They have the option to receive their genotype.

1-2 hours

1 visit (in-person)

Follow-up

Participants are monitored for changes in cannabis use and psychopathology, with assessments conducted annually.

2 years

Annual assessments

Post-Intervention Follow-up

Approximately 1 month after the intervention, participants receive a follow-up interview to assess cannabis use and intervention impact.

1 month

1 follow-up interview

What Are the Treatments Tested in This Trial?

Interventions

• Genetic counselling

Trial Overview

The trial tests if genetic counselling can help young people understand their personal risk of developing severe mental illness due to cannabis use. Participants may learn about their own genetic predisposition towards such risks.

How Is the Trial Designed?

Group I: Genetic counselling Experimental Treatment 1 Intervention

Eligible participants who are randomized will be contacted and offered an invitation to attend the intervention. Genetic counselling will be provided to participants who accept the intervention as a single 1-2 hour session by a board-certified genetic counsellor. During the genetic counselling session, participants will have the option to receive their genotype at rs2494732. Participants will be counselled regarding their individualized risk of developing and of NOT developing SMI based on family history, whether or not they choose to use cannabis, and genotype (if they accept the genetic test results). Approximately 1 month after the intervention, participants will receive a follow-up interview.

Group II: Control group Active Control 1 Intervention

Eligible participants who are not randomized to be offered the intervention will continue with their annual assessments as part of the parent study. These participants will receive the current standard of care (no intervention), and will not be offered or informed of the intervention.

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Published Research Related to This Trial

Psychiatric genetic counseling can empower individuals with psychiatric disorders and their families by providing valuable insights into the genetic factors influencing these conditions, despite the lack of clinical guidelines for genetic testing in this area.

Currently, psychiatric genetic counseling is not widely available, highlighting a significant gap in mental health care that could improve patient outcomes and understanding of psychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-Based Genetic Counseling for Psychiatric Disorders: A Road Map. Austin, JC.[2022]

Genetic counselling for psychiatric disorders, such as affective disorders and schizophrenia, relies on empirical risk figures, while molecular genetic methods can be applied to conditions like Huntington's disease and Alzheimer's, highlighting the varying levels of genetic understanding across these disorders.

The review emphasizes the importance of addressing presymptomatic testing challenges and the teratogenic risks associated with psychopharmacological treatments during pregnancy, which are critical considerations in genetic counselling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Genetic counseling in psychiatric diseases]. Körner, J., Rietschel, M., Nöthen, MM., et al.[2006]

Genetic counseling, while commonly offered for genetic disorders, is not yet standard for individuals with serious mental illnesses, but it could help reduce stigma and fear associated with these conditions.

A multidisciplinary approach involving both psychiatrists and genetic counselors may enhance the effectiveness of genetic counseling, leading to better understanding and management of mental illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The genomic era and serious mental illness: a potential application for psychiatric genetic counseling. Austin, JC., Honer, WG.[2007]

Genetic counselling is essential for individuals at risk of hereditary disorders, as it provides crucial information about the disorder's implications, risk of transmission, and potential preventive measures.

It is particularly important for asymptomatic individuals at risk for late-onset genetic disorders to receive counselling before undergoing predictive genetic testing, ensuring they understand the broader personal and familial consequences of their test results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Genetic counselling]. Rehder, H.[2019]

Genetic counselling plays a crucial role in helping individuals with psychiatric illnesses, such as schizophrenia, by providing information on inheritance patterns and recurrence risks, which can alleviate concerns for patients and their families.

The review highlights the importance of making genetic counselling accessible to all individuals with schizophrenia, as new genetic findings can significantly impact clinical management and support for patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic counselling for schizophrenia in the era of molecular genetics. Hodgkinson, KA., Murphy, J., O'Neill, S., et al.[2020]

In a study of 766 patients at increased risk of hereditary cancer, the General Health Questionnaire (GHQ-28) effectively identified psychiatric morbidity, with 27.9% of participants showing signs of psychological distress.

Key predictors of psychiatric morbidity included being female, aged 41-59, having a personal or family history of cancer, and not having received previous psychiatric treatment, highlighting the importance of considering these factors in mental health screenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychiatric symptoms in a Spanish sample with hereditary cancer risk. Costa-Requena, G., Garcia-Garijo, M., Richart-Aznar, P., et al.[2022]

Genetic factors play a significant role in the vulnerability to psychiatric illnesses, with evidence supporting gene-environment interactions particularly in schizophrenia and affective disorders, as shown through family, twin, and adoption studies.

Genetic counseling can provide empirical risk estimates for individuals based on family history, but it requires a collaborative approach among psychiatrists, geneticists, and social workers to ensure accurate diagnosis and understanding of the information provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic counselling: its need in psychiatry and the directions it gives for future research. Stancer, HC., Wagener, DK.[2019]

Genetic counseling for psychiatric disorders is complex due to the interplay of genetic and environmental factors, and current risk assessments primarily rely on medical history rather than genetic testing.

Emerging tools like polygenic risk scores may enhance the ability to assess and communicate risks for conditions such as schizophrenia, offering new opportunities for diagnosis and management in genetic counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic Risk Assessment in Psychiatry. Peay, HL.[2022]

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Using a trial-within-cohort design, we aim to test if genetic counselling, including the option to receive AKT1 rs2494732 genotype, reduces cannabis use.

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