Stress Effects on Depression and Suicidal Thoughts

Recruiting at 1 trial location

Overseen By Jessica Weed, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Immunosuppressives, Corticosteroids, Chemotherapy, others

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: 2

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the link between childhood trauma, stress, and the risk of depression or suicidal thoughts. Researchers will examine how varying stress levels affect genetic materials, like microRNA, to improve understanding and treatment of mental health issues. The Trier Social Stress Test (TSST) will induce stress in participants. The trial includes different groups, such as those with major depressive disorder (MDD) with and without childhood trauma, and healthy individuals with and without a history of childhood maltreatment. Suitable participants are physically healthy adults who either have major depressive disorder or no history of mental illness.

As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could enhance mental health care for future generations.

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, if you are on immunosuppressive or corticosteroid therapy, you may need to stop, unless it's inhaled, intranasal, topical, or vaginal corticosteroids.

What prior data suggests that the Trier Social Stress Test is safe?

Research has shown that the Trier Social Stress Test (TSST) is generally safe for both healthy individuals and those with depression. In various studies, participants completed this stress test without major side effects. For instance, studies examining stress reactions, such as cortisol levels, found that participants handled the test conditions safely. Other studies assessed changes in mood and heart rate, confirming its safety for individuals with and without a history of suicidal behavior. Overall, researchers consider the TSST safe for use in research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how stress specifically affects depression and suicidal thoughts, which could lead to more personalized treatments. Unlike standard treatments that typically involve medication or therapy, this trial uses the Trier Social Stress Test to investigate stress responses. By understanding how stress impacts individuals with varying histories of childhood maltreatment and suicidality, researchers hope to uncover new insights that could lead to more targeted and effective interventions. This approach is unique because it focuses on the psychological and physiological responses to stress, rather than the symptoms of depression alone.

What evidence suggests that this trial's treatments could be effective for depression and suicidal thoughts?

Research has shown that the Trier Social Stress Test (TSST) helps understand how stress affects individuals, particularly those with conditions like major depressive disorder (MDD). In this trial, participants will be divided into groups, including those with MDD with or without childhood maltreatment and varying levels of suicidality, as well as healthy controls. The TSST measures stress responses, which is crucial for understanding mental health issues like depression and suicidal thoughts. For instance, one study found that individuals with depression reacted differently to stress, showing changes in cortisol levels, a hormone related to stress. Another study found that differences in stress responses are linked to suicidal thoughts in people with depression. These findings suggest that understanding stress responses could aid in assessing and potentially treating depression and suicide risk. ^{1 2 4 6 7}

Who Is on the Research Team?

Yogesh Dwivedi, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 who are physically healthy. Participants can either have a diagnosis of Major Depressive Disorder (MDD) or no history of mental illness at all, and they must be able to understand and agree to the study's procedures.

Inclusion Criteria

Age 18-60

Physically healthy

Willing and able to provide informed consent

Exclusion Criteria

You have been diagnosed with Bipolar Depression

You have been diagnosed with Psychosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Collection of genetic material, including DNA and RNA, from each participant

1 week

1 visit (in-person)

Experimental Stressor

Participants undergo the Trier Social Stress Test (TSST) to assess miRNA expression changes

24 hours

1 visit (in-person)

Follow-up

Participants are monitored for changes in miRNA expression and methylation levels

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Trier Social Stress Test

Trial Overview

The study is looking into how childhood trauma and stress might lead to depression or suicidal thoughts by testing levels of microRNA in the blood. The Trier Social Stress Test will be used as part of this research.

How Is the Trial Designed?

Group I: MDD without CM but with lower suicidality Experimental Treatment 1 Intervention

Major Depressive Disorder without childhood maltreatment but with lower suicidality scores.

Group II: MDD without CM but with elevated suicidality Experimental Treatment 1 Intervention

Major Depressive Disorder without childhood maltreatment, but with elevated suicidality scores.

Group III: MDD with elevated CM and suicidality scores Experimental Treatment 1 Intervention

Major Depressive Disorder with elevator childhood maltreatment and suicidality scores.

Group IV: MDD with CM history but lower suicidality Experimental Treatment 1 Intervention

Major Depressive disorder with childhood maltreatment history but lower suicidality scores.

Group V: Healthy controls without CM history Experimental Treatment 1 Intervention

Healthy controls without childhood maltreatment history.

Group VI: Healthy controls with CM history Experimental Treatment 1 Intervention

Healthy controls with childhood maltreatment history,

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

In a study of 33 euthymic females with a history of major depressive episodes, brain activity in the orbitofrontal cortex during social exclusion was negatively correlated with daily psychological pain in those who had attempted suicide, indicating a link between neural processing and real-world emotional experiences.

This suggests that altered brain responses to social exclusion may contribute to psychological pain and suicide risk, highlighting the importance of understanding individual vulnerabilities in mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prefrontal activity during experimental ostracism and daily psychache in suicide attempters. Olié, E., Husky, M., Bars, EL., et al.[2021]

In a study of 67 adult women, those with a history of suicide attempts showed a significantly higher cortisol response to social stress compared to those without such a history, particularly in individuals with low depression and high impulsivity traits.

All patients experienced increased psychological pain, negative mood, and anxiety immediately after social stress, but those with a history of suicide attempts had a slower recovery of positive mood, indicating that impulsivity may heighten emotional distress and vulnerability in stressful situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impulsiveness level influences the salivary cortisol response and social stress sensitivity in suicidal patients. Alacreu-Crespo, A., Hidalgo, V., Girod, C., et al.[2023]

Exposure therapy methods, specifically Prolonged Exposure (PE) and Virtual Reality Exposure (VRE), significantly reduced suicidal ideation (SI) in active duty military personnel compared to a wait-list control, with a lower probability of SI post-treatment (OR = 0.23).

The study found that reductions in SI occurred early in treatment and were linked to decreases in PTSD symptoms, indicating that PE and VRE can effectively address suicidality in individuals with PTSD without being influenced by baseline SI levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of prolonged exposure and virtual reality exposure on suicidal ideation in active duty soldiers: An examination of potential mechanisms. Norr, AM., Smolenski, DJ., Reger, GM.[2019]

In a study of 1,058 psychiatric patients, 64.7% reported experiencing at least one stressful life event (SLE) in the past three months, which correlated with both recent and future suicidal thoughts and behaviors (STBs).

Specific SLEs, particularly those related to interpersonal rejection, loss, homelessness, and academic failure, were found to significantly increase the risk of STBs, indicating these areas may require heightened clinical attention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stressful Life Events and Near-term Suicidal Risk in a Clinical Population. Cohen, LJ., Hernandez, M., Mokhtar, R., et al.[2023]

In a study of 59 individuals with major depression, severe life stress was primarily linked to cognitive-affective symptoms rather than somatic symptoms, highlighting the specific impact of stress on mental processes and emotions.

The research found a strong connection between severe life events occurring before the onset of depression and suicidal thoughts, suggesting that early life stressors may significantly influence the severity and type of depressive symptoms experienced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Life stress and the symptoms of major depression. Monroe, SM., Harkness, K., Simons, AD., et al.[2019]

In a study involving 54 non-endogenous depressive patients who had attempted suicide, the results of three consecutive dexamethasone suppression tests (DSTs) did not correlate with the lethality of their suicide attempts.

The high rate of nonsuppression in DST results among these patients is likely influenced by stress and various drug interactions, suggesting that these factors may complicate the interpretation of DST in assessing depression severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dexamethasone suppression test repeated after a suicide attempt]. Wilmotte, J., Van Wettere, JP., Depauw, Y., et al.[2015]

In a study involving 32 healthy young males, acute psychosocial stress from the Trier Social Stress Test significantly increased serum levels of brain-derived neurotrophic factor (BDNF) and cortisol, indicating a physiological response to stress.

This research highlights the potential beneficial effects of acute psychosocial stress on BDNF levels, which are important for brain plasticity and development, and suggests further exploration of these effects in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of acute psychosocial stress on the brain-derived neurotrophic factor in humans - a randomized cross within trial. Hermann, R., Schaller, A., Lay, D., et al.[2022]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37542793/

Relationship of stress-reactive cortisol to suicidal intent ...

We examined HPA axis output and reactivity to the Trier Social Stress Test (TSST) via salivary cortisol in depressed individuals (N=68) with a ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666144620300010

Abnormal stress responsiveness and suicidal behavior

Trials of CRF-1 antagonists have suggested effectiveness for the treatment of depression and anxiety, risk factors for suicide, but were discontinued due to ...

3.

psychiatryinvestigation.org

psychiatryinvestigation.org/m/journal/view.php?number=1857

pi :: Psychiatry Investigation

Of the patients included in the study, 20 were diagnosed with major depressive disorder and 19 with bipolar disorder, defined by a previous ...

4.

mental.jmir.org

mental.jmir.org/2023/1/e40163/

The Use of Photoplethysmography in the ... - JMIR Mental Health

PPG holds promise as a potential complementary technology for detecting changes in mental health, including depression and anxiety.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12356671/

A Machine Learning-Based Case–Control Study on Suicide ...

This study investigates speech-based methods for assessing suicide risk in two phases involving 90 patients with major depressive disorder (MDD) or bipolar ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S016517811630631X

Heart rate variability and suicidal behavior

Using the Trier Social Stress Test (TSST), we compared HF HRV between females with and without a history of suicide attempt, all with a ...

7.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT02710279

Response to Social Rejection in Suicidal Behavior ...

The aim of the study is to evaluate the psychological and inflammatory responses to a social stressor validated, the Trier Social Stress Test (TSST) . We will ...