Burns 1999.

Methods	Study design: parallel, randomised controlled trial Number of arms: 2 Experimental arm: sertraline 50 mg/day Control arm: placebo Analysis: intention‐to‐treat: 2 withdrawn and 1 death (treatment), 1 death (placebo), last value carried forward
Participants	Geographical location: UK Setting: 3 hospitals in Manchester Number of participants: 28 Diagnosis: stroke, 1 to 156 months prior to randomisation Inclusion criteria: 1) clinically documented stroke (with or without computed tomography evidence of infarction), 2) presence of lability of mood observed by the referring clinician, 3) at least 1 month having elapsed since stroke, 4) absence of depression and dementia according to DSM‐III‐R criteria Exclusion criteria: 1) less than 1 month since stroke, 2) depression or dementia using DSM‐III‐R criteria Age: overall mean age not reported Numbers included in treatment group: 14 (36% men, mean age 73 years, SD 9.1) Numbers included in control group: 14 (57% men, mean age 67.6 years, SD 8.5) Emotionalism criteria: lability of mood observed by referring clinician
Interventions	Treatment: sertraline 50 mg/day Control: matched placebo Duration: treatment continued for 8 weeks
Outcomes	Primary outcomes Emotionalism/Lability of mood (Lability scale, House 1989) Episodes of tearfulness (4‐point rating scale; 0: 1 episode less than once per week; 1: episodes more than once a week but less than once a day; 2: episodes up to 5 times a day; 3: episodes 6 or more times a day) CIBIC rating scale Secondary outcomes Cognitive functioning (MMSE) Depression (MADRS) Physical functional ability (Barthel Index) Severity of stroke (Scandinavian Stroke Scale) Language dysfunction (Frenchay Aphasia Battery)
Notes	Able to use in analysis Improved score on Lability scale (House 1989) Improved score on CIBIC Diminished tearfulness Leaving the study early Death Adverse events Unable to use in analysis: MADRS, Barthel, MMSE (data not presented)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "After randomization (in blocks of four using a random number allocation list produced by the Department of Medical Statistics…)" pp.683
Allocation concealment (selection bias)	Unclear risk	Comments: not detailed
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "The study was carried out according to a double‐blind placebo controlled ..." pp. 683 Comments: the study authors stated that it is a double‐blinded trial but no details of who were blinded were provided
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "The study was carried out according to a double‐blind placebo controlled ..." pp. 683 Comments: the study authors stated that it is a double‐blinded trial but no details of who were blinded were provided
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Four patients did not complete the study. Two withdrew in the sertraline group ..." pp. 683 "Results are presented on an intention to treat basis, with the last observation carried forward…." pp. 683 Comments: dropouts or exclusions were detailed. Reason for dropouts or exclusions not related to group allocation. Method of how they dealt with the dropouts were provided
Selective reporting (reporting bias)	Low risk	Comments: all prespecified outcomes reported. No trial protocol available prior to randomisation of first participant
Other bias	Unclear risk	Comments: no other bias detected