Hantsoo 2013.

Methods	Randomisation method: unclear Analysis by ITT: yes (LOCF for response and remission analyses) and by evaluable group Power calculation: yes
Participants	Setting: mixed setting ‐ recruitment via local obstetrician‐gynaecologists, paediatricians, mental health professionals, postnatal depression support groups, and advertisements in local newspapers Country: USA Inclusion criteria: aged 18‐45 years, depression onset reported within 3 months after delivery, no psychotropic medication for 5 or more weeks, and given birth within the last 12 months to an infant without serious medical issues. Participants were required to have a diagnosis of postnatal depression based on the SCID, to score ≥ 18 and < 32 on the 19‐item HAM‐D and to have at least "moderate" symptoms on the severity of illness rating of the CGI scale. Only English speaking women were eligible. Exclusion criteria: onset of MDD during pregnancy (indicated on the SCID), screened positive for thyroid disease (unless thyroid condition stable), drug or alcohol dependence in the last 6 months or positive urine drug test during screening, current or history of psychotic disorder (Axis I, including bipolar type I), active suicidal ideation, any significant medical conditions, planning to become pregnant or past failed trial of sertraline. Number recruited: 38 (36 randomised after the placebo run‐in week: 2 participants had > 30% decline in HAM‐D scores during the run‐in week and were removed from the study as per protocol) Number dropped out: 7 dropped out by week 7 (final week) Number analysed: 36 analysed on an ITT basis. Repeated analyses with evaluable group had at least 3 post‐randomisation assessments (33 women) Age (mean ± SD): 30.8 ± 4.0 years, with no between‐group differences; sertraline: 29.6 ± 4.0 years; placebo: 31.7 ± 3.7 yearsS Ethnicity: sertraline group: 16 Caucasian, 1 Hispanic; placebo group: 18 Caucasian,1 Hispanic Years of education (mean ± SD): sertraline group: 14.4 ± 2.0 years; placebo group: 14.0 ± 1.2 years
Interventions	All participants underwent a 1‐week single‐blind placebo lead‐in. Participants who still met the inclusion criteria and had had a less than 30% reduction in HAM‐D scores were randomly assigned to 1 of 2 groups: Sertraline: treatment commenced with 50 mg daily. Dosage was then increased as tolerated by 1 capsule (50 mg) every 1‐2 weeks until clinical remission was obtained or up to a maximum of 4 capsules (200 mg) per day. The mean daily dose (± SD) at week 7 was 100.0 ± 54.0 mg Placebo: dosage followed the pattern described above. The mean dose for the placebo group at week 7 was 119.4 ± 51.8 mg
Outcomes	Primary outcomes: response in psychiatric symptoms: treatment response was defined as a score of ≤ 10 on the HAM‐D, at least a 50% decrease in HAM‐D score from baseline, and a score of "much improved" or "very much improved" on the improvement scale of the CGI (after 6 weeks of treatment); remission defined as per criteria for response to treatment in addition to a HAM‐D score ≤ 7 (after 6 weeks of treatment) Secondary outcomes: trends over time in depressive symptoms as rated by the HAM‐D and the EPDS, and in anxiety symptoms as rated by the HAM‐A. The predominant interest was the treatment group by linear time interaction
Notes	This study was funded by Pfizer (New York, NY, USA), the National Institute of Mental Health (P50 MH099910 and K23 MH01830) and the National Institute of Drug Abuse (K24 DA03031). See footnote for abbreviations and description of outcome measures.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"After the lead‐in, all the subjects.. were randomised to a 6‐week, double‐blind trial"
Allocation concealment (selection bias)	Unclear risk	No details given on allocation concealment
Blinding (performance bias and detection bias) of participants	Low risk	1 participant was excluded after the study began due to accidental unblinding
Blinding (performance bias and detection bias) of personnel	Low risk	"A research pharmacist was responsible for creating a blinding table and distributing the study drug; all other study personnel remained blind to subject treatment status"
Blinding (performance bias and detection bias) of outcome assessors	Low risk	"All other study personnel remained blind to subject treatment status"
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	"A total of 17 women were randomised to the sertraline group and 19 were randomised to placebo, for a total of 36 women in the intent‐to‐treat group. The reasons for failure to the full 7 weeks included clinical deteriorating (n=3, all in the placebo group), loss to follow‐up (n=3), and accidental unblinding (n=1)" There could have been an underestimation of treatment effect as women dropping out for clinical deterioration were all in the control group
Selective reporting (reporting bias)	Unclear risk	Protocol unavailable
Other bias	Unclear risk	No details given on adherence to medication