Halbreich 2002.

Methods	Randomised, double‐blind, 2‐arm parallel study.
Participants	Country: USA and Canada Site: Multi‐centre study in 14 psychiatric and gynaecological outpatient clinics Recruitment: 907 screened, 281 women randomised and 221 completed study. Refer to Table of bias for details of attrition.Women recruited by advertisements in media and by referrals.Mean age 35.9+/‐5.4 and 36.5+/‐4.8 years Inclusion: Age 24 to 45 years, regular menstrual cycles (24 to 36 days), two year self reported history of PMDD, meeting DSM‐IV criteria for PMDD based on 2 cycles prospective screening using DRSP. Mean luteal phase score during 5 most symptomatic days to be at least 75% higher than mean mid follicular phase score. Also a marked level of functional impairment for a minimum of 2 premenstrual days. Required to have at least one of the following symptoms rated as moderate or greater in severity for at least two days during the late luteal phase: depression, irritability, anxiety/tension, or mood lability as well as at least four additional DSM‐IV criterion symptoms of PMDD. Exclusion: Follicular phase Hamilton Rating Scale of Depression score >10, use of oral contraceptives or other hormonal preparations within 2 months before screening, current or lifetime diagnosis of psychiatric disorder, current (or past 6 month) of major depressive disorder (other than PMDD), panic disorder, generalised anxiety disorder, posttraumatic stress disorder or eating disorder, > 38 years having luteinizing hormone levels >38U/L or follicle stimulating hormone levels > 20U/L, hysterectomy or failure to demonstrate ovulation in screening cycles, failure to respond to two or more adequate trials of antidepressants to treat their PMDD, current use of psychotropic medication.
Interventions	Screening: Two screening cycles Placebo run in: One cycle single blind placebo run‐in Intervention: Sertraline 50‐100mg given orally for 3 cycles during luteal phase only (n=142) versus placebo given orally for 3 cycles during luteal phase (n=139) Timing of administration: Based on an algorithm of individual cycle length. Women with 28 day cycle had first dose on day 14 before onset of menses Summary measures: Data based on LOCF data
Outcomes	Hamilton Rating Scale for Depression (HRS‐D); Daily Record Severity of Problems (DRSP); Clinical Global Impression Severity scale (CGI‐S); Clinical Global Impression Improvement scale (CGI‐I); Patient Global Evaluation; Social Adjustment scale (SES); Quality of Life Enjoyment and Satisfaction Questionnaire
Notes	Daily symptom rating Direct expenses funded by Pfizer
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Unclear risk	Method not reported
Blinding (performance bias and detection bias) All outcomes	Low risk	Double blind, identical medication in blister packs containing placebo or sertraline
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	281 randomised, 229 included in intention to‐treat analysis with (81%), with last‐observation‐carried‐forward Twenty‐seven withdrew from sertraline group (protocol violation =3, lost to follow up/ other reason = 13, adverse events = 11) and thirty three from the placebo group (insufficient clinical response = 4, protocol violation =7, lost to follow up / other reason = 21 and adverse events = 1)
Selective reporting (reporting bias)	Unclear risk	Adverse event data collected by spontaneous self‐report
Other bias	Unclear risk	Only women with a history of response to antidepressants randomised. Placebo responders excluded