Premenstrual Dysphoric DisorderSPARK-PMDDNCT07771426
The SPARK-PMDD Study
An observational study of Premenstrual Dysphoric Disorder and PMDD, run by King's College London at 1 site in United Kingdom.
Trial summary
Scientists have found that the immune system, the body's system dedicated to fighting infections, can be in a state of "hyperactivity" (i.e., more active than you would normally expect) in some people with depression and postnatal depression, despite the lack of any actual ongoing infection. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Dysphoric Disorder, PMDD, Premenstrual Dysphoric Disorder ( PMDD)
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2027to 1 Oct 2029
- 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 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants will be recruited from London and surrounding areas, United Kingdom.
Who may be able to join
- Participants must:
- Have been assigned female sex at birth (AFAB), with ovaries
- Be aged between 18-42 years (inclusive)
- Be able to provide written informed consent
- Be premenopausal
- Have regular menstrual cycles (24-35 days; 5-8 menstrual cycles within the previous 6 months)
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- Have a body mass index (BMI) between 18 and 30 kg/m².
- Have access to a computer, tablet or smartphone with an internet connection.
- Be registered with a UK General Practitioner (GP) and consent to the study team contacting their GP if clinically indicated.
- PMDD group only - Participants must additionally:
- Meet DSM-5 diagnostic criteria for Premenstrual Dysphoric Disorder (PMDD), confirmed through prospective symptom ratings and the study diagnostic assessment.
- Healthy control group only - Participants must additionally:
- Have no current or previous diagnosis of PMDD.
- Report no clinically significant premenstrual symptoms on prospective symptom ratings.
- Have no lifetime psychiatric illness
- Meet all other study eligibility criteria.
Who cannot join
- Participants will be excluded if they:
- Have a lifetime history of a psychotic disorder (including schizophrenia, schizoaffective disorder or major depressive disorder with psychotic features) or bipolar disorder (past or present)
- Meet criteria for any other current major psychiatric disorder that would interfere with study participation, as determined by the MINI International Neuropsychiatric Interview.
- Have a history of drug or alcohol dependence within the previous 12 months.
- Have a diagnosed intellectual disability, pervasive developmental disorder or significant neurological disorder (e.g. Alzheimer's disease, epilepsy or Parkinson's disease).
- Are currently pregnant or breastfeeding, or are planning pregnancy during the study period.
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- Have an acute infection, autoimmune disorder, or regularly use anti-inflammatory or antibiotic medication that could influence immune biomarkers.
- Have a current or previous gynaecological condition (e.g. endometriosis or polycystic ovary syndrome) or have undergone gynaecological surgery within the previous 12 months.
- Have used hormonal contraception or other steroid hormone treatment within the previous 6 months (except emergency levonorgestrel contraception or temporary hormone treatment for oocyte cryopreservation that has not affected menstrual cycle regularity).
- Have a significant medical condition that may affect study outcomes (e.g. cancer, inflammatory disease, liver disease, kidney disease or Crohn's disease).
- Are currently participating in a Clinical Trial of an Investigational Medicinal Product (CTIMP). Eligibility following recent participation in a CTIMP will be considered on a case-by-case basis.
- Are assessed as presenting an immediate or high risk of suicide requiring urgent clinical intervention. Suicidal ideation alone is not an exclusion criterion because it is recognised as a feature of PMDD; however, participants identified as being at significant risk will be excluded and referred to appropriate clinical services.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Maurice Wohl Clinical Neuroscience Institute
London, 'London, SE5 9RX
Ellen R Lambert, DClinPsy, 020 7848 0353, ellen.r.lambert@kcl.ac.uk
About this study
Official title: Studying Psychological Changes And inflammatoRy marKers in Premenstrual Dysphoric Disorder (PMDD)
Scientists have found that the immune system, the body's system dedicated to fighting infections, can be in a state of "hyperactivity" (i.e., more active than you would normally expect) in some people with depression and postnatal depression, despite the lack of any actual ongoing infection. This response is referred to as inflammation. This discovery has unveiled unique opportunities to identify new medications to help patients with this heightened inflammation who have also not been responding to their antidepressant medications.
This study aims to explore how inflammation in the body may be linked to symptoms of Premenstrual Dysphoric Disorder (PMDD) across the menstrual cycle, and how thoughts, emotions, and behaviours also may change throughout the cycle. We are recruiting two groups of people: People with a clinical or provisional (suspected) diagnosis of PMDD, and healthy controls who experience mild/no premenstrual changes.
Over a two-month period, participants will complete daily psychological assessments across two menstrual cycles and will come into King's College Hospital (KCH) twice during one menstrual cycle to provide blood samples to measure their inflammation. By comparing these groups, we hope to gain a better understanding of the biological and psychological factors involved in PMDD, with the long-term goal of improving treatment options.
Read the detailed description
Premenstrual dysphoric disorder (PMDD) is a reproductive mood disorder characterised by impairing emotional, cognitive, and physical symptoms that emerge during the premenstrual (luteal) phase of the menstrual cycle and remit shortly after menstruation begins. PMDD may reflect heightened sensitivity to normal fluctuations in ovarian hormones, with emerging evidence suggesting that interactions between sex hormones, inflammation, and psychological processes may contribute to symptom emergence.
Recent prospective research has found that inflammatory markers, including CXCL8 and TNFα, are elevated during the luteal phase and that CXCL8 is associated with PMDD symptom severity. Psychological research has also identified cyclical changes in emotional reactivity, distress tolerance, rumination, and related processes among individuals with PMDD, suggesting that these may represent important and potentially modifiable treatment targets.
The primary aims of this study are to investigate whether inflammatory markers differ between individuals with PMDD and healthy controls across the follicular and luteal phases of the menstrual cycle, and to determine whether inflammatory markers are associated with PMDD symptom severity.
The secondary aims are to examine whether key emotional and cognitive variables differ across menstrual cycle phases between individuals with PMDD and healthy controls, and to determine whether the magnitude of these psychological changes is associated with PMDD symptom severity. The study will use a repeated-measures design, with participants assessed during both the follicular and luteal phases of the menstrual cycle.
Exploratory aims are to examine daily fluctuations in psychological outcomes across two consecutive menstrual cycles and, in a subgroup of 20 participants, to explore the lived experience of PMDD, attitudes towards current biological and psychological treatments, and perspectives on potential novel treatment targets.
- Conditions
- Premenstrual Dysphoric Disorder, PMDD, Premenstrual Dysphoric Disorder ( PMDD), Premenstrual Dysphoric Disorder (PMDD)
- Keywords
- menstrual cycle, pmdd, luteal phase, womens health, reproductive health, reproductive mental health, inflammation, stress, premenstrual, female
- Medical subject headings
- Premenstrual Dysphoric Disorder, 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 |
|---|---|---|
| Control | Eligible participants that pass inclusion and exclusion criteria who do not have premenstrual mood symptoms. | |
| Premenstrual Dysphoric Disorder (PMDD) | Eligible participants that pass inclusion and exclusion criteria who do have premenstrual mood symptoms. Symptoms must be severe enough to meet PMDD criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Biomarkers (Comparing individuals with PMDD and controls)
The investigators will be collecting peripheral blood samples and assaying inflammatory markers, including high-sensitivity C-reactive protein (hs-CRP) and pro-inflammatory and anti-inflammatory cytokines, including interferon (IFN)-γ, interleukin (IL)-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and TNF-α.
Measured: From enrollment until study completion (approximately 3 months)
Secondary outcomes (12)
Sex Steroid Hormones (Comparing individuals with PMDD and controls)
The investigators will be collecting peripheral blood samples and assaying sex steroid hormones including estradiol, progesterone, testosterone, follicle-stimulating hormone, and luteinising hormone.
Measured: From enrollment until study completion (approximately 3 months)
Stress Biomarkers (Comparing individuals with PMDD and controls)
The investigators will collect saliva samples to assess cortisol awakening response.
Measured: From enrollment until study completion (approximately 3 months)
State Difficulties in Emotion Regulation Scale (Comparing individuals with PMDD and controls)
The investigators will collect self-reported emotion dysregulation, including nonacceptance of current emotions, difficulties modulating emotional and behavioural responses in the moment, limited awareness and clarity of current emotions).
Measured: From enrollment until study completion (approximately 3 months)
Emotional Reactivity Scale (Comparing individuals with PMDD and controls)
The investigators will collect self-reported Emotional Sensitivity, Arousal/Intensity, and Persistence
Measured: From enrollment until study completion (approximately 3 months)
Positive and Negative Affect Schedule (Comparing individuals with PMDD and controls)
The investigators will collect self-reported positive and negative affect.
Measured: From enrollment until study completion (approximately 3 months)
Perceived Stress Scale (Comparing individuals with PMDD and controls)
The investigators will collect self-reported subjective stress in the course of daily life.
Measured: From enrollment until study completion (approximately 3 months)
Forms of Self-Criticising/Attacking and Self-Reassuring Scale (Comparing individuals with PMDD and controls)
The investigators will collect self-reported information regarding how self-critical/attacking or how supportive/reassuring people are when things go wrong for them.
Measured: From enrollment until study completion (approximately 3 months)
The State Self-Compassion Scale (Comparing individuals with PMDD and controls)
The investigators will collect self-reported information regarding how people typically act towards themselves in difficult times.
Measured: From enrollment until study completion (approximately 3 months)
Perseverative Thinking Questionnaire (Comparing individuals with PMDD and controls)
The investigators will collect self-reported repetitive negative thinking in daily life.
Measured: From enrollment until study completion (approximately 3 months)
Anger Rumination Scale (Comparing individuals with PMDD and controls)
The investigators will collect self-reported anger rumination or "the tendency to focus on angry moods, recall past anger episodes, and think over the causes and consequences of anger episodes"
Measured: From enrollment until study completion (approximately 3 months)
Cognitive Behavioural Avoidance Scale (Comparing individuals with PMDD and controls)
The investigators will collect self-reported cognitive/behavioural and social/non-social dimensions of avoidance.
Measured: From enrollment until study completion (approximately 3 months)
Entrapment Scale (Comparing individuals with PMDD and controls)
The investigators will collect self-reported feelings of internal and external entrapment, which are experiences of being unable to escape unbearable thoughts, feelings and situations.
Measured: From enrollment until study completion (approximately 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual Dysphoric DisorderStudies 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
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771426
- Sponsor's protocol ID
- 360896
- Other IDs
- 223486/Z/21/Z
- Acronym
- SPARK-PMDD
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying Psychological Changes And inflammatoRy marKers in Premenstrual Dysphoric Disorder (PMDD)
- ClinicalTrials.gov ID
- NCT07771426
- Acronym / sponsor ID
- SPARK-PMDD / 360896
- Conditions
- Premenstrual Dysphoric Disorder, PMDD, Premenstrual Dysphoric Disorder ( PMDD), Premenstrual Dysphoric Disorder (PMDD)
- Keywords
- menstrual cycle, pmdd, luteal phase, womens health, reproductive health, reproductive mental health, inflammation, stress
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 18 Aug 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.
Scientists have found that the immune system, the body's system dedicated to fighting infections, can be in a state of "hyperactivity" (i.e., more active than you would normally expect) in some people with depression and postnatal depression, despite the lack of any actual ongoing infection. This response is referred to as inflammation. This discovery has unveiled unique opportunities to identify new medications to help patients with this heightened inflammation who have also not been responding to their antidepressant medications.
This study aims to explore how inflammation in the body may be linked to symptoms of Premenstrual Dysphoric Disorder (PMDD) across the menstrual cycle, and how thoughts, emotions, and behaviours also may change throughout the cycle. We are recruiting two groups of people: People with a clinical or provisional (suspected) diagnosis of PMDD, and healthy controls who experience mild/no premenstrual changes.
Over a two-month period, participants will complete daily psychological assessments across two menstrual cycles and will come into King's College Hospital (KCH) twice during one menstrual cycle to provide blood samples to measure their inflammation. By comparing these groups, we hope to gain a better understanding of the biological and psychological factors involved in PMDD, with the long-term goal of improving treatment options.
Detailed description
Premenstrual dysphoric disorder (PMDD) is a reproductive mood disorder characterised by impairing emotional, cognitive, and physical symptoms that emerge during the premenstrual (luteal) phase of the menstrual cycle and remit shortly after menstruation begins. PMDD may reflect heightened sensitivity to normal fluctuations in ovarian hormones, with emerging evidence suggesting that interactions between sex hormones, inflammation, and psychological processes may contribute to symptom emergence.
Recent prospective research has found that inflammatory markers, including CXCL8 and TNFα, are elevated during the luteal phase and that CXCL8 is associated with PMDD symptom severity. Psychological research has also identified cyclical changes in emotional reactivity, distress tolerance, rumination, and related processes among individuals with PMDD, suggesting that these may represent important and potentially modifiable treatment targets.
The primary aims of this study are to investigate whether inflammatory markers differ between individuals with PMDD and healthy controls across the follicular and luteal phases of the menstrual cycle, and to determine whether inflammatory markers are associated with PMDD symptom severity.
The secondary aims are to examine whether key emotional and cognitive variables differ across menstrual cycle phases between individuals with PMDD and healthy controls, and to determine whether the magnitude of these psychological changes is associated with PMDD symptom severity. The study will use a repeated-measures design, with participants assessed during both the follicular and luteal phases of the menstrual cycle.
Exploratory aims are to examine daily fluctuations in psychological outcomes across two consecutive menstrual cycles and, in a subgroup of 20 participants, to explore the lived experience of PMDD, attitudes towards current biological and psychological treatments, and perspectives on potential novel treatment targets.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Eligible participants that pass inclusion and exclusion criteria who do not have premenstrual mood symptoms. |
| Premenstrual Dysphoric Disorder (PMDD) | – | –Eligible participants that pass inclusion and exclusion criteria who do have premenstrual mood symptoms. Symptoms must be severe enough to meet PMDD criteria. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be recruited from London and surrounding areas, United Kingdom.
Key inclusion criteria (16 listed)
- Have been assigned female sex at birth (AFAB), with ovaries
- Be aged between 18-42 years (inclusive)
- Be able to provide written informed consent
- Be premenopausal
- Have regular menstrual cycles (24-35 days; 5-8 menstrual cycles within the previous 6 months)
Key exclusion criteria (12 listed)
- Have a lifetime history of a psychotic disorder (including schizophrenia, schizoaffective disorder or major depressive disorder with psychotic features) or bipolar disorder (past or present)
- Meet criteria for any other current major psychiatric disorder that would interfere with study participation, as determined by the MINI International Neuropsychiatric Interview.
- Have a history of drug or alcohol dependence within the previous 12 months.
- Have a diagnosed intellectual disability, pervasive developmental disorder or significant neurological disorder (e.g. Alzheimer's disease, epilepsy or Parkinson's disease).
- Are currently pregnant or breastfeeding, or are planning pregnancy during the study period.
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 Biomarkers (Comparing individuals with PMDD and controls)
Time frame: From enrollment until study completion (approximately 3 months)
The investigators will be collecting peripheral blood samples and assaying inflammatory markers, including high-sensitivity C-reactive protein (hs-CRP) and pro-inflammatory and anti-inflammatory cytokines, including interferon (IFN)-γ, interleukin (IL)-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and TNF-α.
12 secondary outcomes
Sex Steroid Hormones (Comparing individuals with PMDD and controls)
Time frame: From enrollment until study completion (approximately 3 months)
Stress Biomarkers (Comparing individuals with PMDD and controls)
Time frame: From enrollment until study completion (approximately 3 months)
State Difficulties in Emotion Regulation Scale (Comparing individuals with PMDD and controls)
Time frame: From enrollment until study completion (approximately 3 months)
Emotional Reactivity Scale (Comparing individuals with PMDD and controls)
Time frame: From enrollment until study completion (approximately 3 months)
Positive and Negative Affect Schedule (Comparing individuals with PMDD and controls)
Time frame: From enrollment until study completion (approximately 3 months)
Perceived Stress Scale (Comparing individuals with PMDD and controls)
Time frame: From enrollment until study completion (approximately 3 months)
Forms of Self-Criticising/Attacking and Self-Reassuring Scale (Comparing individuals with PMDD and controls)
Time frame: From enrollment until study completion (approximately 3 months)
The State Self-Compassion Scale (Comparing individuals with PMDD and controls)
Time frame: From enrollment until study completion (approximately 3 months)
Perseverative Thinking Questionnaire (Comparing individuals with PMDD and controls)
Time frame: From enrollment until study completion (approximately 3 months)
Anger Rumination Scale (Comparing individuals with PMDD and controls)
Time frame: From enrollment until study completion (approximately 3 months)
Cognitive Behavioural Avoidance Scale (Comparing individuals with PMDD and controls)
Time frame: From enrollment until study completion (approximately 3 months)
Entrapment Scale (Comparing individuals with PMDD and controls)
Time frame: From enrollment until study completion (approximately 3 months)
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 18 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premenstrual Dysphoric Disorder and PMDD, run by King's College London at 1 site in United Kingdom.
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 16 inclusion and 12 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: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 Ellen R Lambert, DClinPsy (020 7848 0353, ellen.r.lambert@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Biomarkers (Comparing individuals with PMDD and controls) (time frame: From enrollment until study completion (approximately 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2026.