Open-Label Placebo Treatment of Women With Premenstrual Syndrome (OLPPMS_1)
Premenstrual Syndrome
About this trial
This is an interventional treatment trial for Premenstrual Syndrome focused on measuring Premenstrual Syndrome, Open-Label Placebo Effect, randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- Moderate to severe PMS
- Between 18 and 45 years of age
- A regular menstrual cycle, i.e., max. +/- 3 days of difference of cycle range
- Menstrual cycle range not longer than 31 or shorter than 24 days
- Participants have a general practioner or gynaecologist to consult
- At least one premenstrual symptom causes the desire for a PMS treatment
Exclusion Criteria:
- Brest feeding at the moment or during the last three months
- Pregnancy
- Failing menstruation onset in the course of two consecutive menstrual cycles
- An essential mental or somatic disease
- Drug or massive alcohol intake or of other psychoactive substances
- Uptake of a new medication within the last 30 days
- Menopause, premenopausal strain or amenorrhoea
- Allergy of one of the ingredients of the placebo dragées (P-Dragees rosa Lichtenstein)
- Women who are surgically sterilised, hysterectomised, or ovariectomised
- BMI above 30
- Actual or recent participation in psychotherapy due to premenstrual symptoms
- Parallel participation in another study with investigational drugs or participation in another PMS study within the last three months
Sites / Locations
- University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Active Comparator
Active Comparator
Treatment as Usual
Integrative Open-Label Placebo
Open-Label Placebo
The treatment as usual (TAU) group will control for regression to the mean, spontaneous remission, natural course of disease, and the participants-provider interaction. Participants of the TAU group are allowed to continue their usual medication intake, given they are already on a stable dose (at least 30 days of intake) and the medication is not listed in the exclusion criteria.
The intervention will encompass an integrative administration of "P-Dragees rosa Lichtenstein", which are pink placebo dragées without any active ingredient. Each dragée contents the following substances: lactose monohydrate; magnesium stearate (Ph. Eur.); microcrystalline cellulose; highly dispersed silicon dioxide; white clay, macrogol glycerolhydroxy stearate (Ph. Eur.); Arabic gum; montanglycol wax; povidone (K 25); talcum; titanium dioxide (E 171); erythrosine; aluminium salt (E 127); calcium carbonate; sucrose; glucose syrup; maize starch; macrogol 6000. All participants will be informed that the administered dragées are placebo dragées and participants will be instructed to take two dragées a day for six weeks. (Amendment regarding dosage since 08/18)
The intervention will encompass an administration of "P-Dragees rosa Lichtenstein", which are pink placebo dragées without any active ingredient. Each dragée contents the following substances: lactose monohydrate; magnesium stearate (Ph. Eur.); microcrystalline cellulose; highly dispersed silicon dioxide; white clay, macrogol glycerolhydroxy stearate (Ph. Eur.); Arabic gum; montanglycol wax; povidone (K 25); talcum; titanium dioxide (E 171); erythrosine; aluminium salt (E 127); calcium carbonate; sucrose; glucose syrup; maize starch; macrogol 6000. All participants will be informed that the administered dragées are placebo dragées and participants will be instructed to take two dragées a day for six weeks. (Amendment regarding dosage since 08/18)