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Microdosing LSD in Women With Premenstrual Disorders

ConditionsPMSPMDD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorFriederike Holze

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • LSD 10 μg every Day

    Drug

    Participants will receive 10 μg LSD every day during the luteal phase

  • LSD 10 μg every other day

    Drug

    Participants receive 10μg LSD every second day during the luteal phase

  • Placebo

    Drug

    Participants receive inactive placebo during the luteal phase

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: 10 μg LSD every day during the acute symptom phaseExperimental treatment 1 intervention
Group B: 10 μg LSD every second day during acute symptom phaseExperimental treatment 1 intervention
Group C: Placebo ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in premenstrual symptom burden

Premenstrual symptom burden measured with the Daily Record of Severity of Problems (DRSP) total score as the mean of the 5 highest symptomatic days of the 7 days before menstruation onset as mean change from baseline (the two monitored cycles before treatment start) of symptoms over all three treatment periods compared with the other study arms.

Time frame
Daily over the 5 cycle study course (average cycle duration is 28 days)

Secondary outcomes

1

Montgomery-Asberg-Depression-Rating Scale (MARDS)

The Montgomery-Asberg-Depression Rating Scale (MADRS) is a ten-item questionnaire widely used to measure severity of depressive symptoms.

Time frame
Ratings will be performed on day 3 of each menstural cycle, over the whole study period of 5 menstrual cycles, to retrospectively rate depressive symptoms during the premenstrual phase (based on an average cycle duration of 28 days)
2

Hamilton Anxiety Rating Scale (HAM-A)

The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-rated scale developed to measure the severity of anxiety symptoms.

Time frame
Ratings will be performed on day 3 of each menstural cycle , over the whole study period of 5 menstrual cycles to retrospectively rate anxiety symptoms during the premenstrual phase ((based on an average cycle duration of 28 days).
3

State-trait anxiety inventory (STAI)

The State-trait anxiety inventory (STAI) is a widely used self-report instrument for assessing anxiety in adults. It includes separate measures of state and trait anxiety.

Time frame
The STAI will be repeatedly assessed 3 times per cycle (twice during the late luteal phase (cycle day 20 and 26 based on a 28-day cycle) and on day 3 after start of mensturation) over the whole study period of 5 menstrual cycles.
4

Beck Depression Inventory (BDI)

The BDI consists of 21 questions developed to measure depression severity. In contrast to the MADRS, the BDI is a self-rating instrument.

Time frame
The BDI will be repeatedly assessed 3 times per cycle (twice during the late luteal phase (cycle day 20 and 26 based on a 28-day cycle) and on day 3 after start of mensturation) over the whole study period of 5 menstrual cycles.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Friederike Holze

Lead sponsor

University Hospital, Basel, Switzerland

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: