Genetic Testing for Depression and Suicide Risk Management

Recruiting at 1 trial location

Overseen By Allison Stewart, MA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Hallucinogens, Methamphetamine, Cocaine

Disqualifiers: Pregnancy, Psychotic disorder, Bipolar, others

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

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

240 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it does exclude participants using certain substances like hallucinogens, methamphetamine, or cocaine in the last two weeks.

What data supports the effectiveness of the treatment Genetic testing for Depression and Suicide Risk Management?

The Genetic Psychosocial Risk Instrument (GPRI) has been shown to be effective in identifying patients at risk for psychological distress, which can help clinicians provide better support and improve patient outcomes. This suggests that using genetic screening tools can enhance the management of mental health conditions by addressing psychosocial needs. ^{1 2 3 4 5}

Is genetic testing for depression and suicide risk management safe for humans?

The Genetic Psychosocial Risk Instrument (GPRI), used in genetic testing, is considered safe and acceptable by both patients and clinicians, helping to identify psychological distress and improve patient care. ^{1 3 5 6 7}

How does genetic testing for depression and suicide risk management differ from other treatments?

This treatment is unique because it uses genetic testing to identify individuals at high risk for depression and suicide, allowing for personalized prevention strategies. Unlike traditional treatments that focus on symptoms, this approach aims to prevent depression by understanding genetic predispositions. ^{8 9 10 11 12}

Eligibility Criteria

This trial is for physically healthy adolescents with major depressive disorder (MDD) and a high risk of suicide, who can provide informed consent. It includes those who recently attempted suicide or have severe suicidal thoughts. Participants must not have certain mental health conditions, recent serious physical health issues, or substance use disorders.

Inclusion Criteria

Suicide attempt group participants must have had an attempt in the previous two weeks that is serious enough to require medical attention and shows evidence of at least a medium level of intent on the Suicide Intent Scale

I have been diagnosed with major depression, have significant symptoms, and have thought about suicide recently.

11-18 Years Old?

Exclusion Criteria

Homicide risk as determined by clinical interview

I haven't had a heart attack, unstable angina, cancer, immunosuppressants, steroids, chemotherapy, or head injuries in the last 6 months.

You have been diagnosed with Bipolar Disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard treatment for depression and are assessed for changes in depressive and suicidal behavior and biomarkers

6 weeks

1 visit (in-person) for blood draw and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Genetic testing
• Interviews
• Questionnaires
• Scales

Trial Overview The study aims to identify new biomarkers in the blood related to depression and suicidality by using genetic testing on exosomes derived from nerve cells. It will also assess how standard treatments for depression affect these potential biomarkers and patient outcomes.

Participant Groups

Group I: MDD Participant Experimental Treatment 1 Intervention

Participants with MDD will return at six weeks for a second blood draw and assessments

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

The Genetic Psychosocial Risk Instrument (GPRI) effectively identifies psychological risk factors in patients undergoing genetic testing, with 41% of participants scoring high for potential distress, indicating a significant need for psychosocial support.

Both patients (94% response rate) and clinicians (54% response rate) found the GPRI to be highly acceptable and useful, with 86% of clinicians believing it enhances patient care by addressing psychosocial needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the acceptability, feasibility, and usefulness of a psychosocial screening tool to patients and clinicians in a clinical genetics service in Australia. Monohan, K., Purvis, R., Sexton, A., et al.[2022]

The Genetic Counselling Outcome Scale (GCOS-24) has been successfully translated and adapted for use in Denmark, demonstrating its feasibility as a Patient Reported Outcome Measure (PROM) in genetic counseling.

The adapted GCOS-24dk showed good internal consistency (Cronbach's α = 0.79) and was well-received by patients, highlighting the importance of local adaptation of outcome measures even in similar healthcare contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translation and Adaptation of the Genetic Counselling Outcome Scale (GCOS-24) for Use in Denmark. Diness, BR., Overbeck, G., Hjortshøj, TD., et al.[2019]

The POETIC trial is assessing the effectiveness of the Genetic Psychosocial Risk Instrument (GPRI) in improving patient empowerment after genetic counselling for inherited cancer predisposition, using a randomized control trial design with patients from two hospitals in Victoria, Australia.

By integrating the GPRI into routine clinical practice, the trial aims to enhance the quality of genetic counselling and provide real-world evidence on its implementation and effectiveness, potentially addressing the growing demand for cancer genetic testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalising genetic counselling (POETIC) trial: Protocol for a hybrid type II effectiveness-implementation randomised clinical trial of a patient screening tool to improve patient empowerment after cancer genetic counselling. Forrest, LE., Tutty, E., De Silva, AP., et al.[2023]

The study aims to evaluate the effectiveness of the 'Psychosocial Aspects of Hereditary Cancer (PAHC) questionnaire' in improving communication and awareness of psychosocial issues among genetic counselors for 264 individuals undergoing cancer genetic counseling in the Netherlands.

By comparing an intervention group that receives feedback from the PAHC questionnaire to a control group without feedback, the study seeks to demonstrate how this tool can enhance the management of psychosocial distress, which affects about 25% of individuals in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of a standardized questionnaire in facilitating personalized communication about problems encountered in cancer genetic counseling: design of a randomized controlled trial. Eijzenga, W., Aaronson, NK., Kluijt, I., et al.[2021]

The European Portuguese version of the Genetic Psychosocial Risk Instrument was successfully translated, adapted, and validated in a study involving 207 participants, primarily women, from the Portuguese Oncology Institute of Porto.

The instrument demonstrated good internal consistency and validity, confirming its reliability for identifying individuals who may need psychosocial support during genetic testing for inherited cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Genetic Psychosocial Risk Instrument (GPRI): A Validation Study for European Portuguese. Gomes, P., Ferreira, T., Mena Matos, P., et al.[2023]

The use of a cancer genetics-specific questionnaire significantly increased the discussion of psychosocial problems during counseling sessions, with 246 participants showing higher engagement in the intervention group compared to the control group.

Participants in the intervention group reported lower levels of cancer worries and psychological distress after counseling, indicating that this approach effectively supports emotional well-being without extending the duration of counseling sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of routine assessment of specific psychosocial problems on personalized communication, counselors’ awareness, and distress levels in cancer genetic counseling practice: a randomized controlled trial. Eijzenga, W., Aaronson, NK., Hahn, DE., et al.[2015]

Individuals undergoing genetic testing for BRCA1 and BRCA2 mutations often experience higher levels of psychological distress, anxiety, and depression compared to non-carriers, indicating a significant emotional impact of positive test results.

The study highlights the need for targeted psychological support for those at risk of distress from genetic testing, particularly as not all individuals react the same way, and emphasizes the importance of including more male participants in future research to better understand their experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological aspects, risk and protective factors related to BRCA genetic testing: a review of the literature. Lombardi, L., Bramanti, SM., Babore, A., et al.[2021]

Genetic testing for depression risk, particularly the 5-HTT genetic test, raises important ethical concerns that need to be addressed in psychiatric practice.

A cautious approach is recommended, suggesting that the use of the 5-HTT test should be limited until its clinical effectiveness and social implications are fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression under stress: ethical issues in genetic testing. Newson, AJ.[2018]

Self-report instruments for depression and suicide risk are effective tools for clinicians to quickly identify adults at risk for depressive disorders, enhancing their ability to make informed clinical decisions.

These screening tools not only provide a baseline measure of a client's behavioral status but also improve the recognition of depression symptoms, even when clients may not openly report them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for depression and suicide: self-report instruments that work. Valente, SM., Saunders, J.[2022]

The study aims to create a genetic test system using polygenic risk scores (PRS) to identify individuals at high genetic risk for depression, which is crucial for preventive medicine.

This research will provide new insights into the genetic architecture of depression in the Russian population, enabling a shift towards preventive strategies in mental health as genetic testing becomes more affordable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[GWAS-based polygenic risk scores for depression with clinical validation: methods and study design in the Russian population]. Kibitov, AO., Mazo, GE., Rakitko, AS., et al.[2020]

As genetic testing for mental illness becomes more common, ethical challenges are expected to arise, particularly due to misunderstandings about the nature and implications of test results.

Studies indicate that both psychiatrists and genetic counselors currently have knowledge gaps that hinder their ability to educate patients effectively, highlighting the need for improved training to help patients make informed decisions about genetic testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticipating the Ethical Challenges of Psychiatric Genetic Testing. Appelbaum, PS., Benston, S.[2021]

The Patient Health Questionnaire (PHQ-9) demonstrated high internal consistency and a good fit for a one-dimensional model, making it a reliable tool for screening depressive disorders in a study of 1,738 adult patients in Chile.

With a cutoff score of seven, the PHQ-9 showed a sensitivity of 0.8 and specificity of 0.7 when compared to the Composite International Diagnostic Interview (CIDI), indicating it is effective for early detection of depression in primary health care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychometric characteristics of the Patient Health Questionnaire (PHQ-9)]. Saldivia, S., Aslan, J., Cova, F., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Assessing the acceptability, feasibility, and usefulness of a psychosocial screening tool to patients and clinicians in a clinical genetics service in Australia. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Translation and Adaptation of the Genetic Counselling Outcome Scale (GCOS-24) for Use in Denmark. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Personalising genetic counselling (POETIC) trial: Protocol for a hybrid type II effectiveness-implementation randomised clinical trial of a patient screening tool to improve patient empowerment after cancer genetic counselling. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The efficacy of a standardized questionnaire in facilitating personalized communication about problems encountered in cancer genetic counseling: design of a randomized controlled trial. [2021]

5. Portugal pubmed.ncbi.nlm.nih.gov

The Genetic Psychosocial Risk Instrument (GPRI): A Validation Study for European Portuguese. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of routine assessment of specific psychosocial problems on personalized communication, counselors’ awareness, and distress levels in cancer genetic counseling practice: a randomized controlled trial. [2015]

7. Germany pubmed.ncbi.nlm.nih.gov

Psychological aspects, risk and protective factors related to BRCA genetic testing: a review of the literature. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Depression under stress: ethical issues in genetic testing. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Screening for depression and suicide: self-report instruments that work. [2022]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[GWAS-based polygenic risk scores for depression with clinical validation: methods and study design in the Russian population]. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Anticipating the Ethical Challenges of Psychiatric Genetic Testing. [2021]

12. Chile pubmed.ncbi.nlm.nih.gov

[Psychometric characteristics of the Patient Health Questionnaire (PHQ-9)]. [2019]