Gao 2016.

Methods	Study type: interventional (clinical trial) Primary purpose: treatment
Participants	274 participants Country: China Setting: outpatient At randomisation number allocated: N = 274, citalopram (n = 91); placebo (n = 91); cognitive behavioural therapy (n = 92) % male: 51.8% Age: mean age, citalopram 66.0 ± 7.3 (n = 91); placebo 67.2 ± 9.6 (n = 91); cognitive behavioural therapy 64.9 ± 8.0 (n = 92) Subtype of stroke: not available Severity of stroke: not available Time since stroke onset: acute ischaemic stroke within the previous 7 days Inclusion criteria: Age > 18 First ever ischaemic stroke meeting World Health Organization (WHO) diagnostic criteria confirmed by MRI No history of depression No antidepressant use prior to the study Exclusion criteria: No consent Premorbid stroke related impairment BI < 10
Interventions	Experimental: citalopram 20 mg per day for a minimum of 3 months + general discussions Comparator 1: placebo + general discussions Comparator 2: placebo + cognitive behavioural therapy
Outcomes	Depressive symptoms (17‐item Hamilton Depression Scale (HAMD17), Bech‐Rafaelsen Melancholia Scale (MES)) at 3 months. Drug side‐effects (Udvalg for Kliniske Undersogelser side‐effect scale at 2, 4, and 6 weeks, and 3 months Performance in ADL (BI) at 3 months Functional impairment (FIM scale) at 3 months
Funding source	Natural Science Foundation of China [81100243, 81171131, 81272564, 81272795, 81100893, 81172197, and 81372484], the Natural Science Foundation of Liaoning Province in China [No. L2013296], and Liaoning Science and Technology Plan Projects [No. 2011225020]
Notes	This trial was particular in that recruitment happened at 4 different time points: at 0 months, 3 months, 6 months and 9 months from discharge. Inclusion criteria required that participants suffered from post‐stroke depression. Participants were invited to complete the BDI and those with a score > 10 were included, provided other criteria were met Group 'placebo + general discussions' and 'citalopram + general discussions were included. No significant differences observed in the 2 included groups Dates study conducted: Participants enrolled between October 2011 and June 2013 Declarations of Interest: none reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization into one of three intervention groups was undertaken by an independent researcher using computer‐generated random number sequences..."
Allocation concealment (selection bias)	Low risk	Quote: "....that were prepared in advance and placed in consecutively numbered, sealed, opaque envelopes."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Study described as "single blind". Quote: "The researcher successively opened the envelopes corresponding to different time periods and determined the intervention by patient number." Quote: "The study therapists acted as clinical evaluators." Quote: "The study therapists were asked not to divulge any treatment information to their patients." Comment: Care providers, investigator and outcome assessors were all aware of allocation.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "The study therapists acted as clinical evaluators." Quote: "The study therapists were asked not to divulge any treatment information to their patients."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "in Group A [placebo + general discussions] , one patient violated protocol in the second time period, one could no longer be reached, and one left the study owing to stroke recurrence in the third time period; in Group B [citalopram + general discussions], persistent side‐effects from the drugs led five patients to leave the study (two owing to orthostatic dizziness, one owing to palpitation, and two owing to constipation)" Comment: Attrition reported for each intervention group and reasons given Group A (placebo + general discussions) 3/91 = 3% attrition Group B (citalopram + general discussions) 5/91 = 5% attrition Overall = 4% attrition
Selective reporting (reporting bias)	Unclear risk	There is no study protocol available. Therefore insufficient information to judge yes or no
Other bias	Low risk	The study appears to be free from other sources of bias