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Not yet recruitingInterventional

Examination of a supplement to manage mood and brain activity in women with premenstrual dysphoric disorder (extreme emotional, behavioral, and physical symptoms in the 1 to 2 weeks before a period)

Premenstrual dysphoric disorder (PMDD) causes intense emotional and physical symptoms, such as severe anxiety and depression, in the weeks before a period. Current treatments do not work for everyone and can cause unwanted side effects. Researchers at Queen Mary University of London want to see if a natural dietary supplement called Ditto can reduce these symptoms and support emotional wellbeing. The trial will involve 100 women aged 18 to 45. Half of the participants will take the Ditto supplement daily for about 12 weeks (covering three menstrual cycles), while the other half will take a harmless dummy pill (placebo). Neither you nor the study team will know which one you receive. You will need to attend two visits in London for questionnaires and a safe, painless brain test called an EEG. You will also complete a 15-minute survey online each week.

At a glance

Status
Not yet recruiting
Enrolment target
100
Start
09 Nov 2026
Estimated completion
30 Mar 2028

What is this study about?

Premenstrual dysphoric disorder, or PMDD, is much more intense than everyday PMS. In the week or two before their period starts, women with PMDD can experience severe mood swings, deep sadness, overwhelming anxiety, and physical discomfort. These symptoms can disrupt work, family life, and relationships. While treatments like antidepressants and hormone therapy are common, they do not work well for everyone and can sometimes cause difficult side effects.

Researchers at Queen Mary University of London are studying whether a nutritional supplement called Ditto might offer a gentle, helpful alternative. The study aims to find out whether the nutrients in Ditto can reduce anxiety, lift mood, and help people manage strong emotions during their monthly cycle.

To see how the supplement works inside the body, the researchers will also measure brain activity. They will use a standard test called an EEG (electroencephalography), where small sensors placed gently on the scalp listen to natural brain signals. This will help scientists find out if the supplement creates positive changes in the brain areas linked to mood and emotional control.

Key takeaways

  • Tests whether a natural daily supplement called Ditto can relieve severe PMDD symptoms.
  • Open to women aged 18 to 45 who experience significant pre-period emotional distress.
  • Lasts 12 weeks (covering three menstrual cycles) with two daily capsules.
  • Requires two visits to Queen Mary University of London for painless brain scans and questionnaires.
  • Includes weekly 15-minute online surveys to track how you feel from home.

Who may be eligible?

This trial is open to women aged 18 to 45 who were assigned female at birth and experience severe PMDD symptoms, whether formally diagnosed or self-reported. Your symptoms before your period will need to meet a specific severity score on a study questionnaire to confirm that you qualify.

To make sure the study is safe and the results are clear, there are several exclusions. You cannot join if you are pregnant or breastfeeding, if you smoke or use nicotine, or if you regularly drink more than 10 units of alcohol per week (around 4 or 5 standard pints of beer or medium glasses of wine). You must also be free from other mental health conditions, neurological disorders, and bowel problems such as irritable bowel syndrome (IBS), Crohn's disease, or coeliac disease.

In addition, you cannot take part if you currently use certain prescription medications. These include antidepressants, hormonal treatments for PMDD, ADHD medications, sleeping pills, antibiotics, or thyroid medicine (levothyroxine). You must also not have any known allergies to chamomile, saffron, ragweed, or zinc, and you must not have used the Ditto supplement before.

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.

  1. Are you a woman aged 18 to 45 (assigned female at birth)?
  2. Do you experience severe mood changes or anxiety in the 1 to 2 weeks before your period?
  3. Are you not pregnant, not breastfeeding, and a non-smoker?
  4. Are you free from gut conditions like IBS, Crohn's, or coeliac disease?
  5. Are you currently not taking antidepressants, PMDD hormone therapy, or ADHD medicine?
  6. Are you able to visit London twice and complete weekly online questionnaires?
Answer every question to see your result.

What does participation involve?

Taking part lasts for about 12 weeks, which covers three menstrual cycles. You will be randomly chosen to take two capsules of either the Ditto supplement or a dummy pill (placebo) by mouth every day. You will visit Queen Mary University of London twice: once at the beginning of the study and once at the end. Each visit takes around three hours and involves answering questions about your health and having a painless, harmless brain-wave check (EEG). In between these two visits, you will fill out a short 15-minute survey on your phone or computer once a week to track your mood and any side effects. In total, you will give around 9 to 10 hours of your time across the 12 weeks.

Potential risks and benefits

You might notice an improvement in your mood and PMDD symptoms while taking part, though this cannot be guaranteed, particularly as you may receive a dummy pill. The information you provide will help scientists learn more about PMDD and could help improve future care. The physical risks are very low because the supplement uses food-based ingredients, though some people might get a mild upset stomach. The brain test is completely safe and does not hurt. Answering questions about your emotions can sometimes feel sensitive or tiring, but you are always free to skip questions, take breaks, or withdraw from the study at any time without giving a reason.

Locations (1)

  • Queen Mary University of London
    Approximate
    London, England

Common questions

What is an EEG and will it hurt?

An EEG is a completely painless test that records natural brain waves. A soft cap with small sensors sits on your head to listen to brain signals. It does not put any electricity into your body and is very safe.

Will I definitely receive the Ditto supplement?

No. You will be randomly placed into one of two groups. You will have an equal chance of receiving either the Ditto supplement or an inactive dummy pill (placebo).

Can I stay on my regular antidepressants or hormonal pills?

No. To ensure the study results are accurate, you cannot take antidepressants, ADHD medications, or hormonal treatments for PMDD during this trial.

Do I have to travel to London to take part?

Yes. While the weekly surveys are done online from home, you will need to attend two in-person appointments at Queen Mary University of London.

Can I leave the study if I feel uncomfortable?

Yes. Taking part is completely voluntary. You can choose to stop participating at any point, and your standard medical care will never be affected.

How to find out more

Paul Faulkner

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

Interested in taking part?

Register your interest

Share your details and the research team for "Examination of a supplement to manage mood and brain activit…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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