Premenstrual dysphoric disorder
Conditions
Interventions
Trade Name: Esmya
Product Name: esmya
Pharmaceutical Form: Tablet
INN or Proposed INN: ulipristal acetate
CAS Number: 126784-99-4
Other descriptive name: ULIPRISTAL ACETATE
Concentration unit: mg mill
Sponsors
Uppsala University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: – be essentially healthy – be a woman between 20-45 years of age (i.e. >19 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: – has or has had any steroid hormonal treatment during the previous 3 months – treatment with antidepressive or antipsychotic drugs or other psychopharmaceuticals during the previous 3 months (including over-the-counter or prescription drugs for PMS symptoms) – ongoing psychiatric disease – prior history of severe depression requiring hospitalization – prior history of suicide attempts – Severe medical conditions in the opinion of the investigator that may interfere with compliance to treatment or study procedures – history of drug or alcohol abuse, or use more than 30 g of alcohol per day (corresponds to ~2 glasses of wine/day) – breast-feeding, pregnancy or plans of a pregnancy during the study period – has a clinically relevant finding on the physical examination or blood testing – is working night shifts on a regular basis (rare occasions of night work may be acceptable) – participate concurrently in any other clinical trial – hearing impairments or visual impairment (> 5 degrees myopic/hyperopic or profound astigmatism) – profound fear of confined spaces – Other contraindications for magnetic resonance imaging
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to establish if a ulipristal acetate (esmya®) can be used for treatment of PMDD. ;Secondary Objective: Secondary objectives include the investigation of neural correlates of symptom relief during SPRM treatment.;Primary end point(s): The primary end-point for measuring the treatment effect will be symptom assessment using a validated daily rating scale, the Daily Record of Severity of Problems (DRSP) Primary outcome variables •The primary variable will comprise the change in sum of scores for irritability, depression, tension and lability (DRSP items 1a-4b), i.e. a maximal of 8 x 6 = 48 points possible. •The proportion of women with remission of PMDD will be compared between treatments. Remission is defined as a decrease in severity of symptoms (items 1a-4b) of 75% or more during the late luteal phase days in the treatment cycle compared to the corresponding days during the qualification period. ;Timepoint(s) of evaluation of this end point: The final 5 days of the luteal phase in treatment cycle 2 and 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in scores for the individual symptoms in the DRSP. Change in total score of all 21 items in the DRSP will be compared between treatments (e.g. Cohen et al 2002; Yonkers et al 2005). Quality of Life, by the EQ-50, will be compared between the two treatments. Brain emotional stimuli processing assessed using functional magnetic resonance imaging (fMRI); Brain resting state activity (rsMRI); Brain morphology measured by MRI. The Montgomery-Asberg Depression Rating Scale (MADRS), the State Anxiety Inventory (STAI), ;Timepoint(s) of evaluation of this end point: The final 7 days of treatment cycle 3. | — |
Countries
Sweden
Contacts
Public ContactInger Sundström Poromaa
Uppsala University
Outcome results
None listed