Biochemical and neuropsychological effects on Premenstrual Dysphoric Disorder after acute administration of escitalopram

Göteborgs universitet0 个研究点目标入组 40 人开始时间: 2014年4月8日最近更新: 2016年4月25日

适应症

试验速览

暂无简介。

•Inclusion cirteria for patients with Premenstrual Dysphoric Disorder:
•1. Age: 18-45 years
•2. Regular menstrual cycle.
•3. Diagnostic criteria A-C for PDD according to DSM-IV.
•4. At least 50% elevation of the symptom irritability from follicular phase (mean from day 6 to 10) to luteal phase (mean from day -5 to -1) measured with daily VAS scale (1-100 mm). During the last 5 days of the luteal phase the mean score for irritability must be = 30 mm.
•5. Written informed consent.
•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 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Current (<1 year) psychiatric disorder other than premenstrual dysphoric disorder according to M.I.N.I. diagnostic interview.
•2. Moderate or high suicide risk according to M.I.N.I. diagnostic interview.
•3. Current regular psychopharmacological treatment (including anxiolytics and sedative-hypnotics).
•4. Earlier experience of SSRI indicating that patient does not tolerate this treatment. Known intolerance to any excipient in the given tablets.
•5. Known QT prolongation or enhanced risk for QT prolongations.
•6. Current or past somatic disease and/or past psychiatric disorder and/or current medication regarded by the clinical investigator as potentially interfering with study examinations and/or the effect of escitalopram, or in other way inappropriate or representing a risk according to the clinical investigator.
•7. Breastfeeding or pregnancy/inadequate contraceptive method.
•8. Circumstances indicating to the clinical investigator that the participant not will be able to complete the trial.
•9. Difficulties in understanding the implications of participation in the study, e.g. language difficulties.

发起方

Göteborgs universitet