Status:
NOT_YET_RECRUITING
Microdosing LSD in Women With Premenstrual Disorders
Lead Sponsor:
Friederike Holze
Conditions:
PMS
PMDD
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
The investigators aim to investigate the role of the serotonin 2A receptor in women with premenstrual disorders. This study uses a double-blind, randomized, controlled design with 3 arms: Intervention...
Detailed Description
Premenstrual disorders (premenstrual syndrome (PMS) and Premenstrual Dysphoric Disorder (PMDD)) affect many women (20 - 30% for PMS and 1.2 - 6.4% for PMDD) and are associated with affective symptoms,...
Eligibility Criteria
Inclusion
- Inclusion crtieria:
- Between 18-45 years.
- Are menstruating and have cycles with a duration between 21 - 35 days.
- Meet DSM-V criteria for PMDD or criteria for severe PMS with daily ratings over 2 cycles to confirm luteal symptoms.
- For PMDD, participants must have a minimal average luteal phase score of mild (≥3 on a 6-point scale) for at least 5 Symptoms on the DRSP including 1 mood symptom during the 5 most symptomatic of the final 7 luteal phase days and the first 2 days of menses onset, and the average follicular phase score must not be \>2 on these same items.
- For severe PMS, participants must have a minimal average luteal phase score of mild (≥3 on a 6-point scale) for at least 4 Symptoms on the DRSP including 1 mood symptom, during the 5 most symptomatic of the final 7 luteal phase days and the first 2 days of menses onset, and the average follicular phase core must not be \>2 on these same items.
- Have reported PMDD/PMS symptoms for the majority of menstrual cycles (\>9 of 12) during the year prior to screening.
- Sufficient understanding of the German language
- Sufficient understanding of the study procedures and risks associated with the study.
- Participants must be willing to adhere to the study procedures and sign the consent form.
- Willing not to drive or operate heavy machinery during the acute treatment phases of the study.
- Willing to refrain from more than 7 standard alcoholic drinks a week, more than 10 cigarettes a day, and any illicit substances.
- Willing to use effective contraceptive measures throughout study participation.
- Exclusion Criteria:
- Known hypersensitivity to LSD
- Current treatment for PMS/PMDD
- Use of an oral hormonal contraceptive \< 6 months.
- Past or present bipolar or psychotic disorder, including depressive disorder with psychotic features.
- First degree relative with a psychotic disorder.
- Significant prodromal psychotic symptoms (Prodromal Questionnaire-16 symptoms ≥ 6).
- Borderline personality disorder.
- Current post-traumatic stress disorder.
- Pregnant or breastfeeding
- Planned pregnancy.
- Current or recent history of significant suicide ideation or suicide behavior within the past 6 months.
- Current substance use disorder (\< 12 months) other than tobacco smoking.
- Other illness that excludes repeated LSD administration or requires interfering medication.
- Participation in another clinical trial (currently or within the last 30 days)
Exclusion
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07189299
Start Date
October 1 2025
End Date
January 1 2030
Last Update
September 23 2025
Active Locations (1)
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1
Clinical Pharmacology & Toxicology, University Hospital Basel
Basel, Canton of Basel-City, Switzerland, 4056