Premenstrual Dysphoric Disorder
Conditions
Interventions
Trade Name: Cipralex - Escitalopram (Lundbeck)
Product Name: Cipralex
Product Code: N06AB10
Pharmaceutical Form: Tablet
INN or Proposed INN: ESCITALOPRAM
CAS Number: 128196-01-0
Concentration unit: mg
Sponsors
Uppsala University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: – informed consent – essentially healthy – 18-49 years of age – have a regular menstrual cycle (25-31 days) in the opinion of the investigator – accept to undergo brain magnetic resonance imaging assessment – confirmed PMDD according to DSM-IV verified in two menstrual cycles for the patient group Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - hormonal contraceptive use within three months prior to inclusion - pregnancy, breast feeding - presence of other ongoing psychiatric disorders - treatment with benzodiazepines, or other psychotropic drugs (including SSRI) within six months prior to inclusion - previous history of non-response to SSRI treatment - presence of other major diseases - visual impairment (> 5 degrees myopic/hyperopic or profound astigmatism), previous brain surgery, profound fear of confined spaces, and regular contraindications for magnetic resonance imaging
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the neuropsychological underpinnings of PMDD symptoms relief at the brain structural and functional level comparing PMDD patients before and after treatment with escitalopram and considering placebo effects;Secondary Objective: to assess the relationship between neural correlates and psychiatric, psychological, endocrine and genetic measures;Primary end point(s): Primary endpoints •Brain emotional stimuli processing assessed using functional magnetic resonance imaging (fMRI) by the following tasks: emotion discrimination task (Hariri task, EDT), point subtraction aggression paradigm (PSAP), and reward task (IOWA). •Brain resting state activity (rsMRI); •Brain morphology measured by MRI. Variables used to asses treatment response •Treatment effectiveness (difference in mean DRSP scores for core PMDD symptoms during the last two weeks of each treatment cycle, and change from baseline in mean DRSP scores, as well as response and remission according to DSM criteria). ;Timepoint(s) of evaluation of this end point: pretreatment and during the second and last treatment cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Treatment related changes in quality of life (EDQ5). • The Montgomery-Asberg Depression Rating Scale (MADRS), the State Anxiety Inventory (STAI), the Swedish universities Scale of Personality (SSP), the Aggression Questionnaire-revised Swedish version (AQ-RSV), the Positive and negative affect schedule (PANAS); • Transcript and DNA methylation profiles in blood of type-A ?-aminobutyric acid receptor (GABRA), serotonin transporter (5HTT), tryptophan hydroxylase (TPH), monoamine oxidase (MAOA), catechol-o-metyltransferase (COMT), and brain-derived neurotrophic factor (BDNF) genes, and BDNF protein levels: • Blood levels of pregnenolone, 17-OH-pregnenolone, 17-OH-progestyerone, cortisol, cortisone, 11-deoxycortisol, DHEA, allopregnanolone, androstenedione, testosterone, dihydrotestosterone, estrone, estriol, estradiol and (S)-citalopram; bioavailable fraction of hormones in saliva. • Genotype of 5-HTTLPR, TPH2 rs4131347, MAOA-uVNTR, COMT Val158Met, BDNF Val66Met polymorphisms, and tag-SNPs in the GABRA gene; ;Timepoint(s) of evaluation of this end point: pretreatment and during the second and last treatment cycle | — |
Countries
Sweden
Contacts
Public ContactInger Sundström-Poromaa
Uppsala University
Outcome results
None listed