Not yet recruitingOBSERVATIONAL

The SPARK-PMDD Study

This study, called SPARK-PMDD, aims to understand the link between the body's natural defence system (inflammation) and Premenstrual Dysphoric Disorder (PMDD). Some research suggests inflammation can be higher in people with certain mood conditions. We want to see how inflammation and feelings, thoughts, and actions change across the menstrual cycle in women with PMDD compared to those who don't have it. By studying these differences over two months, including blood tests and daily check-ins, we hope to find new ways to help improve treatments for PMDD in the future.

At a glance

Status

Not yet recruiting

Sponsor

King's College London

Enrolment target

120

Start

01 Jan 2027

Estimated completion

01 Oct 2029

Premenstrual Dysphoric Disorder PMDD Premenstrual Dysphoric Disorder ( PMDD)Premenstrual Dysphoric Disorder (PMDD)

What is this study about?

Premenstrual Dysphoric Disorder, or PMDD, is a severe form of PMS where women experience very difficult emotional, thinking, and physical symptoms in the weeks leading up to their period. These symptoms usually go away shortly after their period starts. Scientists believe that PMDD might be related to how sensitive a woman's body is to normal changes in hormones during her menstrual cycle. There's also growing evidence that a process called inflammation – where your body's immune system responds as if there's a threat, even without an infection – might play a role, along with how you think and feel.

This study is looking into whether inflammation in the body is different in women with PMDD compared to women who don't have these severe premenstrual symptoms. We also want to explore how feelings, thoughts, and actions change throughout the menstrual cycle in both groups. By understanding these biological and psychological factors better, the research aims to uncover new possibilities for improving how PMDD is treated.

To do this, we'll ask participants to track their symptoms daily for two menstrual cycles. They will also visit King's College Hospital twice during one cycle to provide blood samples, which will help us measure inflammation levels. We hope these discoveries will lead to more effective and helpful treatments for PMDD in the long run.

Key takeaways

This study aims to link body inflammation with PMDD symptoms.
It involves daily symptom tracking for two months and two hospital visits for blood tests.
Compares women with PMDD to those with mild/no premenstrual changes.
Helps researchers understand PMDD better to develop new treatments.
Participation includes filling out questionnaires and providing blood samples.

Who may be eligible?

This study is looking for women aged between 18 and 42 who have regular periods. We need two groups: one group of women who have been diagnosed with PMDD (or strongly suspect they have it), and another group of healthy women who experience very mild or no premenstrual symptoms.

To join, you must have been assigned female at birth, have ovaries, and be able to give your informed consent. Your Body Mass Index (BMI) should be between 18 and 30, and you'll need access to a computer or smartphone with internet. You also need to be registered with a UK doctor (GP).

There are some reasons why you wouldn't be able to join. For example, if you've ever had a diagnosis of bipolar disorder or a psychotic disorder, or if you've had issues with drug or alcohol dependence in the last year. You also can't take part if you have certain other health conditions like an autoimmune disorder, a severe learning disability, or if you're pregnant, breastfeeding, or planning to become pregnant during the study. If you regularly use anti-inflammatory or antibiotic medications that could affect your immune system, you also wouldn't be eligible.

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.

Are you a woman, aged 18-42, with regular periods?
Do you have PMDD or very mild/no premenstrual symptoms?
Do you have internet access for daily online forms?
Is your BMI between 18 and 30?
Are you not currently pregnant or breastfeeding, or planning to be during the study?
Do you not have a history of bipolar disorder or severe learning disability?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will be involved for about two months. During this time, you'll complete daily online questionnaires on your computer or phone for two full menstrual cycles. These questions will ask about your feelings, thoughts, and any symptoms you might be experiencing.

During one of these menstrual cycles, you will need to visit King's College Hospital (KCH) in London twice. On each visit, a small amount of blood will be taken to measure your inflammation levels. These visits will be scheduled at specific times in your cycle, for example, once around the time of ovulation and once closer to your period. No new medications will be given as part of this study, and you will not have any follow-up appointments after the two-month period concludes.

Potential risks and benefits

Taking part in a study like this helps us learn more about PMDD, which could lead to better treatments for many women in the future. You might also gain a better understanding of your own menstrual cycle and how it affects you. There are some small risks, such as minor discomfort or bruising from blood tests, or feeling a little emotional when answering questions about your symptoms. You are free to stop participating at any time without giving a reason, and it won't affect any medical care you currently receive.

Locations (1)

Maurice Wohl Clinical Neuroscience Institute
Verified postcode
London, United Kingdom

Common questions

What is PMDD?

PMDD stands for Premenstrual Dysphoric Disorder. It's a severe form of PMS where women experience intense emotional, mental, and physical symptoms in the week or two before their period, which then disappear when their period starts.

What does 'inflammation' mean?

Inflammation is your body's natural way of protecting itself, like when you get a cut and it swells. This study is looking into whether the body's defence system might be 'overactive' in PMDD, even without an infection.

How will my personal information be kept private?

All information you provide will be treated with strict confidence. Your name and other identifying details will be kept separate from your study data, which will be identified only by a unique code.

Do I have to stop my current medication to join?

The study information doesn't mention having to stop existing medications. Please check with the research team directly about any medications you are taking if you are considering joining.

Will I be paid for taking part?

The study summary does not mention payment for participation. It's common for studies to cover travel expenses, so this is a good question to ask the research team.

How to find out more

Ellen R Lambert, DClinPsy

ellen.r.lambert@kcl.ac.uk 020 7848 0353 Official trial record

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