RecruitingOBSERVATIONAL

Stress, Inflammation and Neuroimaging in Major Depressive Disorder as Compared to Premenstrual Dysphoric Disorder

This study aims to understand the differences between major depressive disorder (MDD) and premenstrual dysphoric disorder (PMDD) in women. Researchers will look at how brains respond to stress, hormone levels, and inflammation. They will compare women with MDD, women with PMDD, and healthy women. The study pays special attention to how a woman's menstrual cycle affects these differences. By understanding these factors better, the hope is to develop more personalised and effective treatments for these conditions. It's a key step towards improving care for women with depression and PMDD.

At a glance

Status

Recruiting

Sponsor

University Hospital Tuebingen

Enrolment target

Start

04 Jan 2024

Estimated completion

01 Jul 2026

MDD PMDD

What is this study about?

You might know that millions of women experience mood changes, like sadness or irritability. Sometimes these feelings are mild, but for others, they can be severe and affect daily life. This study is looking at two specific conditions: Major Depressive Disorder (MDD), often just called depression, and Premenstrual Dysphoric Disorder (PMDD). PMDD is a severe form of PMS, where symptoms like feeling down, anxious, or irritable become very intense in the week or two before a period starts.

Researchers want to understand how these two conditions differ and why they affect women. They're especially interested in how the body reacts to stress, what's happening in the brain, and how inflammation (the body's natural response to harm or infection) might be involved. They believe that understanding these differences could lead to much-improved ways of diagnosing and treating these conditions, helping women get the right support.

To do this, the study will compare three groups of women: those with MDD, those with PMDD, and healthy women who don't have either condition. They will look at how each group responds to stress, paying close attention to different phases of the menstrual cycle, as hormone changes can play a big role in mood. By gathering this detailed information, scientists hope to pinpoint the unique features of MDD and PMDD, paving the way for more targeted and personalised treatments in the future.

Key takeaways

This study compares women with depression (MDD), PMDD, and healthy women.
It investigates how stress, brain activity, and inflammation are linked to these conditions.
Researchers will look at how the menstrual cycle affects these factors.
The goal is to find better ways to diagnose and treat MDD and PMDD specifically in women.
Participation involves brain scans, blood tests, and questionnaires at different times in your cycle.

Who may be eligible?

To join this study, you need to be a woman between 18 and 40 years old. You should have regular menstrual periods, meaning no menopause and your periods should generally come every 25 to 31 days. Your body weight should also be within a healthy range.

You can't join if you have certain medical conditions, especially if they affect your hormones or metabolism, or if you're currently pregnant or have given birth/breastfed in the last year. If you've been on hormonal birth control (like the pill) in the last three months, or if you're taking certain regular mental health medications, you might also not be able to participate. Also, if you do a lot of competitive sports or work changing shifts, this study might not be right for you.

Healthy participants must not have any neurological or mental health conditions. If you have MDD or PMDD, the study will assess your specific diagnosis to ensure you fit the research criteria. The researchers will discuss all these points with you to see if the study is suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am a woman between 18 and 40 years old.
I have regular menstrual periods (every 25-31 days).
I have a generally healthy body weight.
I am not pregnant or breastfeeding, nor have I given birth in the last year.
I haven't taken hormonal birth control (like the pill) in the last three months.

Answer every question to see your result.

What does participation involve?

The study involves several assessments. You'll have brain scans (fMRI) to see how your brain works and blood tests to measure stress hormones like cortisol and inflammation markers. These measurements will be taken at two different times during your menstrual cycle to see how your hormones affect your responses. You'll complete questionnaires about your mood and symptoms. The total duration of your participation will be discussed with the research team, but it will involve multiple visits for the various tests.

Potential risks and benefits

Participating in this study could help scientists better understand depression and PMDD, potentially leading to improved treatments for women in the future. While there's no direct guarantee of personal benefit, you would be contributing to valuable medical knowledge. The potential risks involve the usual discomfort of blood tests and lying still during brain scans. You might also experience some stress during the stress reactivity tests. You are free to ask questions at any time and can withdraw from the study without giving a reason at any point, and this will not affect your medical care.

Locations (1)

University Hospital Tübingen, Klinik für Psychiatrie und Psychotherapie
Verified postcode
Tübingen, Germany· Recruiting

Common questions

What is PMDD?

PMDD is a severe form of premenstrual syndrome (PMS) where women experience very intense mood changes, like depression, anxiety, or irritability, in the week or two before their period starts.

What is "stress reactivity"?

Stress reactivity refers to how your body and brain respond when you encounter a stressful situation, looking at things like hormone levels and brain activity.

Will I receive any treatment during the study?

This study is focused on understanding the conditions, not providing treatment. Any current treatments you are on will be discussed with the research team.

What do the brain scans involve?

You will have an fMRI scan, which is a type of MRI that measures brain activity while you're in the scanner. It's safe and doesn't use radiation.

How will my data be kept private?

All your personal information will be kept confidential and anonymised for research purposes, meaning your identity will not be linked to the results.

How to find out more

Elise Bücklein, M.Sc.

elise.buecklein@uni-tuebingen.de +497071-2982627 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.