PerimenopauseNCT07910552
The Immunobiological Mechanisms of Depression in Perimenopause
An observational study of Perimenopause and Major Depressive Episode (MDE), run by Van Andel Research Institute at 4 sites in United States.
Trial summary
This project aims to identify immunobiological mechanisms underlying the development of depression during the perimenopause. During the perimenopause, the risk for recurrence of depression is increased 13-fold among women who previously had depression. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopause, Major Depressive Episode (MDE)
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Mar 2025to 30 Nov 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women between 40-55 years of age will be approached in the screening. Our recruiters will discuss the study in a private room with potential study participants, to first check whether the approached women meet the STRAW criteria for perimenopause (≥ 7-day persistent; recurrence within 10 cycles) variability in their menstrual cycle), before scheduling consent.
Who may be able to join
- • Biological women, age 40 to 55.
- Undergoing perimenopause according to STRAW criteria [1].
- All races and national origins can be included.
- English speaking (since all clinical rating scales to be used here have not been developed and validated for non-English speaking populations).
- Able to give informed consent.
- Able to comply with and complete study procedures.
- Willing and able to take part of the different steps in the study, including follow-up research visit after 8 weeks and blood draws.
Who cannot join
- • Pregnant, nursing or transgender women (due to their hormonal status being different than what is investigated in this project).
- Incarcerated individuals.
- Subjects with dementia or otherwise cognitively impaired subjects with difficulty understanding the study procedures.
- Patients with an active somatic disorder primarily involving the immune system (autoimmune diseases such as Crohn's disease, multiple sclerosis, or rheumatoid arthritis; or hematological diseases such as lymphoma or leukemia or HIV). Research staff will consult with the PIs in cases of uncertainty.
- Patients with untreated hormonal conditions affecting the reproductive system.
- Patients on chronic and systemic immunomodulatory treatment. Examples are patients with a liver or kidney transplant and medications used for disorders involving the immune system, as mentioned above. Examples of immunomodulatory treatments are cyclosporin, azathioprine, infliximab and chronic corticosteroid treatment.
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- Women already taking hormonal substitution before the research visit (either for perimenopause or/and as contraceptive) or replacement will be excluded,
- Patients taking lithium, neuroleptic- or mood stabilizing medications (antidepressants, such as SSRIs and SNRIs, are allowed).
- Patients undergoing active treatment for any form of cancer (chemotherapy or immunomodulatory treatments).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 3 recruiting
- Active, not recruiting
Van Andel Institute
Grand Rapids, Michigan, 49503
- Recruiting
Pine Rest Christian Mental Health
Grand Rapids, Michigan, 49548
Nagy Youssef, MD, PHD, 616-281-6363, Nagy.Youssef@pinerest.org
Janelle Kassien, janelle.kassien@pinerest.org
- Recruiting
Western Michigan University Homer Stryker M.D. School of Medicine
Kalamazoo, Michigan, 49048
Eric Achytes, MD, MS, 269-337-4350, Eric.Achtyes@WMed.edu
Heather Mayle, heather.mayle@wmed.edu
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Lauren M. Osborne, MD, 212-746-3154, lmo2003@med.cornell.edu
Nathaly Tavarez, nat4012@med.cornell.edu
About this study
This project aims to identify immunobiological mechanisms underlying the development of depression during the perimenopause. During the perimenopause, the risk for recurrence of depression is increased 13-fold among women who previously had depression. Moreover, perimenopause overlaps with the age span exhibiting the highest suicide rate for women. The perimenopause can last for several years and starts when estrogen and progesterone levels begin to fluctuate, gradually declining. Sex hormones are powerful modulators of the immune response and the investigators therefore propose that changes in lymphocytes play a central role in depression during this time. Notably, our previous work has demonstrated deficient regulatory T-cell responses in women with post- partum depression and identified a specific pro-inflammatory profile that predicts depression during pregnancy. Importantly, our new pilot data derived from women with severe depression in the perimenopausal age span reveals alterations in tryptophan metabolites that control T- cell responses as well as in the methylation of genes involved in T-cell fate and chromatin remodeling. Taken together, these data support the hypothesis that the perimenopausal hormonal shifts induce a pro-inflammatory state, regulated by chromatin modifications in T-cells, that triggers depression in vulnerable women.
To test this hypothesis, the investigators will enroll 180 perimenopausal women aged 40-55, approximately half with depression and half without a diagnosis of depression. All participants will complete psychiatric assessments and provide blood samples to measure sex hormones, inflammation and immune cell changes. Women with depression will be reassessed approximately eight weeks later to identify blood markers that change as depressive symptoms improve.
This project seeks to improve understanding of the biological mechanisms of depression during perimenopause and aid the development of predictive biomarkers and more effective treatments.
Read the detailed description
Perimenopause constitutes a high-risk period for developing depressive symptoms and recurrence of depression. Although hormonal changes are considered to trigger symptom development, little is known about the underlying biological mechanisms or why some women are at increased risk. Since both estrogen and progesterone induce changes in the immune response, this project focuses on the immunobiological mechanisms underlying depression in perimenopause.
The investigators' working hypothesis is that perimenopausal hormonal shifts induce a pro-inflammatory state, modulated by intrinsic chromatin properties in lymphocytes, that contributes to depression. The investigators propose that the risk of developing perimenopausal depression depends on levels of aryl hydrocarbon receptor (AhR)-binding ligands in plasma, the chromatin landscape of immune cells affected by these ligands, and sex hormone levels that act in concert with the ligands to sustain a pro-inflammatory state.
Aims:
- Determine plasma tryptophan metabolite and cytokine patterns in perimenopausal depression.
- Define epigenetic mechanisms in lymphocytes that confer vulnerability to developing depression in perimenopause.
- Identify inflammatory and metabolic markers that normalize in recovering women.
To test these hypotheses, the investigators will enroll 180 perimenopausal women aged 40-55 years at Weill Cornell Medicine, Western Michigan University Homer Stryker M.D. School of Medicine, and Pine Rest Christian Mental Health Services. Approximately 90 women will have depression, and 90 will have no or mild depressive symptoms without a diagnosis of depression. Perimenopausal status will be established using the Stages of Reproductive Aging Workshop criteria. A structured diagnostic interview using DSM-5 criteria will confirm or rule out a diagnosis of depression.
Participants will undergo clinical assessments and blood sampling. The Hamilton Depression Rating Scale will be the primary measure of depression severity. Additional assessments will measure menopausal symptoms, anxiety, trauma history, suicidal thoughts and behaviors, and functioning. Blood samples will be collected between 7:00 and 10:00 AM.
For Aim 1, the investigators will quantify plasma tryptophan metabolites, inflammatory cytokines and sex hormones. The working hypothesis is that women with depression in perimenopause have reduced levels of immunoregulatory tryptophan metabolites, worsening peripheral inflammation. Biomarker levels will be compared between groups and examined in relation to depression severity and sex hormone levels.
For Aim 2, peripheral immune cell populations will be characterized using flow cytometry. ATAC sequencing, Illumina EPIC arrays and RNA sequencing will assess chromatin accessibility, DNA methylation and gene expression in sorted naïve T-cells. The investigators expect to detect differences in transcriptional regulation, reflected in distinct inflammatory responses in women with depression in perimenopause.
For Aim 3, the approximately 90 women with depression will be reassessed eight weeks after the first visit, with repeat clinical assessments and blood sampling. This observational follow-up will include women starting hormone therapy as part of their clinical care and women who do not. The working hypothesis is that women receiving hormone therapy will show reduced pro-inflammatory cytokines and increased regulatory T-cells, along with improvement of depressive symptoms.
The findings may aid the identification of women at risk and the development of more effective treatments. The investigators predict that these distinct inflammatory responses will be linked to the development of depression. The investigators also expect improvement of depressive symptoms and reversal of immunobiological markers in women receiving hormonal therapy. The investigators envision that the project will lead to an improved understanding of the molecular underpinnings of depression during perimenopause, aiding the future identification of biomarkers of women at risk as well as the development of more effective treatments.
- Conditions
- Perimenopause, Major Depressive Episode (MDE)
- Keywords
- perimenopause, depression, immune, inflammation, DNA methylation, hormone, RNAseq, ATAC seq
- Medical subject headings
- Depression, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case, perimenopause women with depression | Control perimenopause women without depression | |
| Control, perimenopause women without depression | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory markers
IL-1-33 and acute phase reactants ICAM, VCAM, CRP, SAA) will be measured using high-sensitivity ELISAs, Mesoscale platform or Luminex platforms
Measured: Inflammatory markers will be measured at baseline and the follow up time point: 8 weeks after the first visit for the depressed group.
thyroid status, hormonal status
Measure estrogen, progesterone, luteinizing hormone and follicle stimulating hormone, cortisol levels for controlling their interactions with cytokines and AhR ligands.
Measured: At the baseline and follow up visit (8 weeks)
glucose levels
For controlling interactions with hormones and cytokines, AhR ligands.
Measured: At the baseline and follow up visit (8 weeks)
hemoglobin levels
For controlling interactions with hormones and cytokines, AhR ligands.
Measured: At the baseline and follow up visit (8 weeks)
Secondary outcomes (4)
RNA sequencing
Assess gene expression levels
Measured: At baseline
methylation analysis
Assess genome-wide methylation levels
Measured: At baseline
ATAC sequencing
ATAC sequencing on the naïve T-cells to assess chromatin accessibility.
Measured: At baseline
FACS profiling
sorting and staining of lymphocytes to identify immune cell profile changes
Measured: until the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start13 Mar 2025
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Van Andel Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Lena Cecilia Brundin, MD, PhD, Principal investigator, Van Andel Research InstituteNagy Youssef, MD, PhD, Principal investigator, Pine Rest Christian Mental HealthEric Achytes, MD, MS, Principal investigator, Western Michigan University Homer Stryker M.D. School of MedicineLauren M. Osborne, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910552
- Sponsor's protocol ID
- 24021
- Other IDs
- 1R01MH139201-01
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
PubMed 22193671Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.
PubMed 9635069Kulkarni J, Gavrilidis E, Hudaib AR, Bleeker C, Worsley R, Gurvich C. Development and validation of a new rating scale for perimenopausal depression-the Meno-D. Transl Psychiatry. 2018 Jun 28;8(1):123. doi: 10.1038/s41398-018-0172-0.
PubMed 29955034Brewin CR, Rose S, Andrews B, Green J, Tata P, McEvedy C, Turner S, Foa EB. Brief screening instrument for post-traumatic stress disorder. Br J Psychiatry. 2002 Aug;181:158-62. doi: 10.1017/s0007125000161896.
PubMed 12151288Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
PubMed 26606250BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
PubMed 13688369Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
PubMed 3204199Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, Do MT. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004 Sep 2;2:45. doi: 10.1186/1477-7525-2-45.
PubMed 15345062Hamilton M. Rating depressive patients. J Clin Psychiatry. 1980 Dec;41(12 Pt 2):21-4.
PubMed 7440521Youssef NA, Green KT, Beckham JC, Elbogen EB. A 3-year longitudinal study examining the effect of resilience on suicidality in veterans. Ann Clin Psychiatry. 2013 Feb;25(1):59-66.
PubMed 23376871McCall WV, Benca RM, Rosenquist PB, Youssef NA, McCloud L, Newman JC, Case D, Rumble ME, Szabo ST, Phillips M, Krystal AD. Reducing Suicidal Ideation Through Insomnia Treatment (REST-IT): A Randomized Clinical Trial. Am J Psychiatry. 2019 Nov 1;176(11):957-965. doi: 10.1176/appi.ajp.2019.19030267. Epub 2019 Sep 20.
PubMed 31537089Youssef NA, Lockwood L, Su S, Hao G, Rutten BPF. The Effects of Trauma, with or without PTSD, on the Transgenerational DNA Methylation Alterations in Human Offsprings. Brain Sci. 2018 May 8;8(5):83. doi: 10.3390/brainsci8050083.
PubMed 29738444Sherer ML, Voegtline KM, Park HS, Miller KN, Shuffrey LC, Klein SL, Osborne LM. The immune phenotype of perinatal anxiety. Brain Behav Immun. 2022 Nov;106:280-288. doi: 10.1016/j.bbi.2022.09.005. Epub 2022 Sep 14.
PubMed 36115543
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immunobiological Mechanisms of Depression in Perimenopause
- ClinicalTrials.gov ID
- NCT07910552
- Acronym / sponsor ID
- 24021
- Conditions
- Perimenopause, Major Depressive Episode (MDE)
- Keywords
- perimenopause, depression, immune, inflammation, DNA methylation, hormone, RNAseq, ATAC seq
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Van Andel Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Nov 2031 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to identify immunobiological mechanisms underlying the development of depression during the perimenopause. During the perimenopause, the risk for recurrence of depression is increased 13-fold among women who previously had depression. Moreover, perimenopause overlaps with the age span exhibiting the highest suicide rate for women. The perimenopause can last for several years and starts when estrogen and progesterone levels begin to fluctuate, gradually declining. Sex hormones are powerful modulators of the immune response and the investigators therefore propose that changes in lymphocytes play a central role in depression during this time. Notably, our previous work has demonstrated deficient regulatory T-cell responses in women with post- partum depression and identified a specific pro-inflammatory profile that predicts depression during pregnancy. Importantly, our new pilot data derived from women with severe depression in the perimenopausal age span reveals alterations in tryptophan metabolites that control T- cell responses as well as in the methylation of genes involved in T-cell fate and chromatin remodeling. Taken together, these data support the hypothesis that the perimenopausal hormonal shifts induce a pro-inflammatory state, regulated by chromatin modifications in T-cells, that triggers depression in vulnerable women.
To test this hypothesis, the investigators will enroll 180 perimenopausal women aged 40-55, approximately half with depression and half without a diagnosis of depression. All participants will complete psychiatric assessments and provide blood samples to measure sex hormones, inflammation and immune cell changes. Women with depression will be reassessed approximately eight weeks later to identify blood markers that change as depressive symptoms improve.
This project seeks to improve understanding of the biological mechanisms of depression during perimenopause and aid the development of predictive biomarkers and more effective treatments.
Detailed description
Perimenopause constitutes a high-risk period for developing depressive symptoms and recurrence of depression. Although hormonal changes are considered to trigger symptom development, little is known about the underlying biological mechanisms or why some women are at increased risk. Since both estrogen and progesterone induce changes in the immune response, this project focuses on the immunobiological mechanisms underlying depression in perimenopause.
The investigators' working hypothesis is that perimenopausal hormonal shifts induce a pro-inflammatory state, modulated by intrinsic chromatin properties in lymphocytes, that contributes to depression. The investigators propose that the risk of developing perimenopausal depression depends on levels of aryl hydrocarbon receptor (AhR)-binding ligands in plasma, the chromatin landscape of immune cells affected by these ligands, and sex hormone levels that act in concert with the ligands to sustain a pro-inflammatory state.
Aims:
- Determine plasma tryptophan metabolite and cytokine patterns in perimenopausal depression.
- Define epigenetic mechanisms in lymphocytes that confer vulnerability to developing depression in perimenopause.
- Identify inflammatory and metabolic markers that normalize in recovering women.
To test these hypotheses, the investigators will enroll 180 perimenopausal women aged 40-55 years at Weill Cornell Medicine, Western Michigan University Homer Stryker M.D. School of Medicine, and Pine Rest Christian Mental Health Services. Approximately 90 women will have depression, and 90 will have no or mild depressive symptoms without a diagnosis of depression. Perimenopausal status will be established using the Stages of Reproductive Aging Workshop criteria. A structured diagnostic interview using DSM-5 criteria will confirm or rule out a diagnosis of depression.
Participants will undergo clinical assessments and blood sampling. The Hamilton Depression Rating Scale will be the primary measure of depression severity. Additional assessments will measure menopausal symptoms, anxiety, trauma history, suicidal thoughts and behaviors, and functioning. Blood samples will be collected between 7:00 and 10:00 AM.
For Aim 1, the investigators will quantify plasma tryptophan metabolites, inflammatory cytokines and sex hormones. The working hypothesis is that women with depression in perimenopause have reduced levels of immunoregulatory tryptophan metabolites, worsening peripheral inflammation. Biomarker levels will be compared between groups and examined in relation to depression severity and sex hormone levels.
For Aim 2, peripheral immune cell populations will be characterized using flow cytometry. ATAC sequencing, Illumina EPIC arrays and RNA sequencing will assess chromatin accessibility, DNA methylation and gene expression in sorted naïve T-cells. The investigators expect to detect differences in transcriptional regulation, reflected in distinct inflammatory responses in women with depression in perimenopause.
For Aim 3, the approximately 90 women with depression will be reassessed eight weeks after the first visit, with repeat clinical assessments and blood sampling. This observational follow-up will include women starting hormone therapy as part of their clinical care and women who do not. The working hypothesis is that women receiving hormone therapy will show reduced pro-inflammatory cytokines and increased regulatory T-cells, along with improvement of depressive symptoms.
The findings may aid the identification of women at risk and the development of more effective treatments. The investigators predict that these distinct inflammatory responses will be linked to the development of depression. The investigators also expect improvement of depressive symptoms and reversal of immunobiological markers in women receiving hormonal therapy. The investigators envision that the project will lead to an improved understanding of the molecular underpinnings of depression during perimenopause, aiding the future identification of biomarkers of women at risk as well as the development of more effective treatments.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case, perimenopause women with depression | – | –Control perimenopause women without depression |
| Control, perimenopause women without depression | – | – |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women between 40-55 years of age will be approached in the screening. Our recruiters will discuss the study in a private room with potential study participants, to first check whether the approached women meet the STRAW criteria for perimenopause (≥ 7-day persistent; recurrence within 10 cycles) variability in their menstrual cycle), before scheduling consent.
Key inclusion criteria (7 listed)
- • Biological women, age 40 to 55.
Key exclusion criteria (9 listed)
- • Pregnant, nursing or transgender women (due to their hormonal status being different than what is investigated in this project).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inflammatory markers
Time frame: Inflammatory markers will be measured at baseline and the follow up time point: 8 weeks after the first visit for the depressed group.
IL-1-33 and acute phase reactants ICAM, VCAM, CRP, SAA) will be measured using high-sensitivity ELISAs, Mesoscale platform or Luminex platforms
thyroid status, hormonal status
Time frame: At the baseline and follow up visit (8 weeks)
Measure estrogen, progesterone, luteinizing hormone and follicle stimulating hormone, cortisol levels for controlling their interactions with cytokines and AhR ligands.
glucose levels
Time frame: At the baseline and follow up visit (8 weeks)
For controlling interactions with hormones and cytokines, AhR ligands.
hemoglobin levels
Time frame: At the baseline and follow up visit (8 weeks)
For controlling interactions with hormones and cytokines, AhR ligands.
4 secondary outcomes
RNA sequencing
Time frame: At baseline
methylation analysis
Time frame: At baseline
ATAC sequencing
Time frame: At baseline
FACS profiling
Time frame: until the end of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 22193671Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 9635069Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.
- Background: PubMed 29955034Kulkarni J, Gavrilidis E, Hudaib AR, Bleeker C, Worsley R, Gurvich C. Development and validation of a new rating scale for perimenopausal depression-the Meno-D. Transl Psychiatry. 2018 Jun 28;8(1):123. doi: 10.1038/s41398-018-0172-0.
- Background: PubMed 12151288Brewin CR, Rose S, Andrews B, Green J, Tata P, McEvedy C, Turner S, Foa EB. Brief screening instrument for post-traumatic stress disorder. Br J Psychiatry. 2002 Aug;181:158-62. doi: 10.1017/s0007125000161896.
- Background: PubMed 26606250Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
- Background: PubMed 13688369BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
- Background: PubMed 3204199Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
- Background: PubMed 15345062Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, Do MT. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004 Sep 2;2:45. doi: 10.1186/1477-7525-2-45.
- Background: PubMed 7440521Hamilton M. Rating depressive patients. J Clin Psychiatry. 1980 Dec;41(12 Pt 2):21-4.
- Background: PubMed 23376871Youssef NA, Green KT, Beckham JC, Elbogen EB. A 3-year longitudinal study examining the effect of resilience on suicidality in veterans. Ann Clin Psychiatry. 2013 Feb;25(1):59-66.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lena Cecilia Brundin, MD, PhD principal investigator
Van Andel Research Institute
Nagy Youssef, MD, PhD principal investigator
Pine Rest Christian Mental Health
Eric Achytes, MD, MS principal investigator
Western Michigan University Homer Stryker M.D. School of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perimenopause and Major Depressive Episode (MDE), run by Van Andel Research Institute at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lena Cecilia Brundin, MD, PhD (616-234-5379, lena.brundin@vai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory markers (time frame: Inflammatory markers will be measured at baseline and the follow up time point: 8 weeks after the first visit for the depressed group.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07910552, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.