Eriksson 2008.

Methods	Randomised, double‐blind, placebo‐controlled trial with 3 arms
Participants	Country: Sweden Site: University clinic Recruitment: Newspaper advertisements, phone interview Inclusion: Women aged at least 18, meeting DSM‐IV A‐C criteria for PMDD (confirmed at interview), with regular menstrual cycles and using adequate non hormonal contraception. Exclusion: Axis 1 psychiatric disorder, psychotic disorder, major depressive disorder of less than 2 years, Montgomery‐Asber depression scores at baseline of over 15, use of hormonal contraception, recurrent severe headache or migraine, regular use of a drug that might influence PMDD symptoms or interact with trial medication, use of psychoactive drug within 2 weeks of screening visit or of fluoxetine within 5 weeks of visit. Mean age 36‐38 years
Interventions	Screening: 2‐3 screening cycles confirming cyclicity of symptoms Placebo run‐in: no Intervention: 1. 10 mg escitalopram (n=54) 2. 20 mg escitalopram (n=53) 3. placebo (n=51) for 3 cycles Timing of administration: luteal phase only ‐ taken from estimated day of ovulation to first full day of menstruation Summary measures: change scores(VAS) and end scores (PGE)
Outcomes	Sum self‐assessed VAS scores of 4 key symptoms (irritability, tension, affective lability, depressed mood) ‐ primary outcome. Patient Global Evaluation scores reported in review (all symptom ‐ end scores) Clinician rated symptom scale (PMTS‐O) Function ‐ assessed with Sheehan Disability Scale Clinician‐rated global severity (CGI‐S) and global improvement (CGI‐I) Response rate (a priori defined as 50 decrease in VAS symptoms or in irritability, or self‐rating as much improved (PGE) or clinician‐rated as by CGI‐I) Patient ‐assessed "usefulness of medication" using Patient Global Evaluation (PGE)
Notes	Funded by pharmaceutical company H Lundbeck A/S VAS data presented in graphical form: emailed author to request effects estimates and SDs ‐ no reply received
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Code generated by sponsor, details unknown to investigators
Allocation concealment (selection bias)	Low risk	Sequential enrolment, details unknown to investigators
Blinding (performance bias and detection bias) All outcomes	Low risk	All study personnel and participants blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	158 women randomised; seven excluded from analysis (incomplete baseline assessment, concomitant use of another antidepressant) 151/158 analysed (96%) by intention to treat with last observation‐carried‐forward
Selective reporting (reporting bias)	Unclear risk	Adverse events not prospectively reported
Other bias	Low risk	Groups had similar prognostic factors at baseline