Grade 1998.

Study characteristics
Methods	Study design: parallel design Number of arms: 2 Experimental arm: methylphenidate Control arm: matched placebo
Participants	Geographical location: USA Setting: inpatient Stroke criteria: all subtypes Method of stroke diagnosis: via clinical signs and CT (100%) Time since stroke: on average 18 days (SE 4, treatment group) and 19 days (SE 4, control group) prior to randomisation Inclusion criteria: not reported Exclusion criteria: 1) childbearing potential; 2) hypersensitivity to methylphenidate; 3) significant medical conditions, schizophrenia, delusional disorder, motor tics, uncontrolled epilepsy, malignant hypertension, prominent agitation; 4) current antidepressant treatment Total number randomised in this study: 21 Number randomised to treatment group: 10 (40% men, mean age 70 years, SE 4) Number randomised to control group: 11 (64% men, mean age 73 years, SE 3) Total number included in final analysis: 21 Number included in treatment group for final analysis: 10 Number included in control group for final analysis: 11
Interventions	Treatment: methylphenidate, 5 mg (1 in morning) to 60 mg (3 x 10 mg twice daily) daily; dose increased if no adverse events reported Control: matched placebo Treatment duration: treatment continued for 3 to 4 weeks Follow‐up: not reported.
Outcomes	Primary outcomes Depression measured using the HDRS and ZDS Secondary outcomes Dependence measured using the FIM Cognitive function measured using the MMSE Leaving the study early
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Using a random numbers table, the pharmacy department randomly assigned all patients to receive either methylphenidate or placebo in identical capsules." pp. 1048
Allocation concealment (selection bias)	Low risk	Quote: "... assigned all patients to receive either methylphenidate or placebo in identical capsules ... " pp. 1048
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "All patients and their families, as well as nurses and clinical examiners, were unaware of which participants were receiving methylphenidate." pp. 1048
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "To check the integrity of the double‐blind design, a short questionnaire was given after the last rating period. Patients, examiners (psychiatrist, physical therapist, and psychologist), and other study staff (nurses and physiatrist) were asked to indicate whether they believed the patient was given methylphenidate or placebo (respondents could also answer 'don't know')." pp. 1048
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comments: ITT analysis reported
Selective reporting (reporting bias)	Unclear risk	Comments: no trial protocol available to compare with the publication
Other bias	Low risk	Comments: there was no statistically significant difference between the treatment and control group in baseline demographic characteristics