Understanding immune clues to depression in perimenopause

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows perimenopausal women aged 40-55 to explore how immune system changes and chromatin patterns in lymphocytes relate to depression risk. Researchers will examine plasma metabolites, cytokines, and epigenetic markers, aiming to identify biological signatures linked with depressive symptoms during perimenopause. The project will also look for markers that normalize when mood improves. Participants will contribute blood samples and undergo follow-up assessments over an 8-week period at multiple sites in Michigan. The goal is to clarify immunobiological mechanisms that may inform future interventions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* • 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.

Exclusion Criteria:

* • 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.
  * 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).

Where it's running

• Pine Rest Christian Mental Health
  Grand Rapids, Michigan, United States Recruiting
• Western Michigan University Homer Stryker M.D. School of Medicine
  Kalamazoo, Michigan, United States Recruiting
• Weill Cornell Medicine
  New York, New York, United States Recruiting
• Van Andel Institute
  Grand Rapids, Michigan, United States Active not recruiting

Study contacts

• Principal investigator: Lena Cecilia Brundin, MD, PhD — Van Andel Research Institute
• Study coordinator: Lena Cecilia Brundin, MD, PhD
• Email: lena.brundin@vai.org
• Phone: 616-234-5379

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.