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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on understanding the genetic links between depression, including major depressive disorder (MDD), and suicide risk. The researchers aim to identify biomarkers (biological indicators) that could enhance future treatments and care for these conditions. Participants will undergo genetic testing (also known as genetic screening or genetic analysis) and answer questions to assess how standard depression treatments affect their symptoms and biological markers. The trial seeks individuals who are physically healthy and either have a confirmed diagnosis of MDD or have recently experienced a serious suicide attempt. Non-psychiatric individuals with no history of major mental illness can also participate as controls. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to better understanding and treatment of depression and suicide risk.

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 prior data suggests that genetic testing is safe for participants?

Research has shown that genetic testing for depression and suicide risk is safe and acceptable to both patients and doctors. Studies have not identified any major safety concerns with the testing itself. This testing helps identify genetic factors related to depression and suicide risk without harming participants.

No reports of negative effects from the testing process exist, indicating that people generally handle genetic testing for depression and suicide risk well. It's important to note that safety here refers to the testing process itself, not any subsequent changes in treatment.

In summary, genetic testing for depression and suicide risk has no known safety issues for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores genetic testing as a way to manage depression and suicide risk, which is a fresh approach compared to traditional treatments like medication and therapy. Unlike standard methods, this trial aims to understand how a person's genes might influence their mental health, potentially allowing for more personalized treatment plans. By identifying genetic markers linked to depression and suicide risk, the trial could pave the way for tailored interventions that are more effective and have fewer side effects. This innovative angle could revolutionize how we approach mental health care, making it more precise and individualized.

What evidence suggests that this trial's treatments could be effective for depression and suicide risk management?

Research shows that genes can significantly influence the development of Major Depressive Disorder (MDD). Studies involving families, twins, and adopted individuals have demonstrated this link. One study found that a specific gene variation appeared in 67.9% of people with MDD, increasing their risk of developing the disorder. In this trial, participants will undergo genetic testing to help doctors select the right antidepressants for each person, leading to better treatment results. Specifically, patients who underwent genetic testing experienced more positive outcomes compared to those who received standard care. This suggests that genetic testing could be a helpful tool in managing depression and improving treatment success. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

I am healthy, willing to participate, and can give my consent (or have a guardian who can if I'm under 18).

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

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]

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 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7006978/

Genetics of Treatment Outcomes in Major Depressive ...

Pharmacogenetic testing is a useful and increasingly widespread tool to assist in antidepressant prescription.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3077049/

Overview of the Genetics of Major Depressive Disorder - PMC

Genetic factors play important roles in the development of MDD, as indicated by family, twin, and adoption studies.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2589004224004243

Article Identification of a strong genetic risk factor for major ...

The ROC analysis revealed that the odds ratio for the gene polymorphism causing MDD was 5.28 and the positive rate in MDD patients was 67.9% so ...

4.

research.va.gov

research.va.gov/currents/0722-Genetic-testing-may-benefit-patients-with-depression.cfm

Genetic testing may benefit patients with depression

The researchers also found that the patients who underwent genetic testing had more positive outcomes, compared with patients in usual care.

5.

nature.com

nature.com/articles/s41380-023-01957-9

The genetic basis of major depressive disorder

I review data indicating that there is a large genetic component unique to MDD that remains inaccessible to minimal phenotyping strategies.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11130888/

The Contribution of Genetic Testing in Optimizing Therapy ...

(4) Conclusions: In patients with RDD and a poor response to antidepressant therapy, pharmacogenetic testing allows for treatment adjustment, ...

7.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2806144

Screening for Depression and Suicide Risk in Adults: US ...

The USPSTF concludes that the evidence is insufficient on the benefit and harms of screening for suicide risk in adults, including pregnant and postpartum ...

8.

insideprecisionmedicine.com

insideprecisionmedicine.com/topics/informatics/global-genetics-study-of-1-7m-people-finds-new-depression-risk-variants/

Global Genetics Study of 1.7M People Finds New ...

A groundbreaking study has now identified 287 genetic risk loci linked to the disorder—49 of them newly discovered.

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8692426/

Ethical concerns relating to genetic risk scores for suicide

Even if genetic prediction of suicidality improves significantly, information about genetic risk scores must be distributed cautiously, with genetic counseling, ...

10.

withpower.com

withpower.com/trial/phase-depressive-disorder-major-7-2022-957da

Genetic Testing for Depression and Suicide Risk ...

The Genetic Psychosocial Risk Instrument (GPRI), used in genetic testing, is considered safe and acceptable by both patients and clinicians, helping to identify ...