About this trial
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 1: 10 micg LSD for \~10 days during the late luteal phase (for 3 cycles) Intervention 2: 10 micg LSD every other day for \~10 days during the late luteal phase (for 3 cycles) Control intervention: Placebo for \~10 days during the late luteal phase (for 3 cycles) Each participant will be treated in only one arm. The study employs a parallel design with three treatment arms and consists of a two-cycle observational phase followed by a three-cycle treatment phase.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- LSD 10 μg every Day
- LSD 10 μg every other day
- Placebo
Treatment groups
Sponsors and collaborators
Friederike Holze
Lead sponsor
University Hospital, Basel, Switzerland
Sponsor institution