Mechanisms behind the positive effect of the drug escitalopram on premenstrual dysphoric disorder

• Conditions: Premenstrual Dysphoric Disorder; MedDRA version: 18.1Level: PTClassification code 10051537Term: Premenstrual dysphoric disorderSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-000309-60-SE
• Lead Sponsor: Göteborgs universitet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-08
• Last Update Posted: 25 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: It is known that the serotonin reuptake inhibitor escitalopram is effective for the treatment of premenstrual dysphoric disorder. The aim of the present study is to investigate the mechanisms underlying this effect. The questions to be addressed are i) if women with PMDD display differences in blod and/or CSF between the symptomatic (premenstrual) and the asymptomatic (postmenstrual) cyclic phase regarding levels of gonadal steroids, neurosteroids, inflammatory markers or various markers of brain neurotransmission, ii) to which extent these parameters correlate with each other and/or symptom intensity and iii) to what extent these parameters are affected by treatment with escitalopram.;Secondary Objective: Not applicable;Primary end point(s): Serotonin levels in CSF;Timepoint(s) of evaluation of this end point: After inclusion in the trial each patient is monitored during four complete menstruation cycles and the beginning of the fifth, i.e. approx. four months.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not relevant.;Timepoint(s) of evaluation of this end point: Not relevant.