Fruehwald 2003.

Methods	Parallel design Analysis: per protocol: Withdrawals: death (1 treatment), withdrawn owing to AEs (1 treatment, 2 control), all excluded from analysis
Participants	Location: Austria Setting: inpatients Treatment: 28 people, mean ± SD age 65 ± 14 years, 46% men Control: 26 people, mean ± SD age 64 ± 14 years, 71% men Stroke criteria: ischaemic stroke and PICH; diagnosis via clinical signs and CT (100%); stroke on average 11 days prior to randomisation Depression criteria: psychiatric interviews, HDRS score > 15 Other entry criteria: not stated Comparability of treatment groups: non‐significant trend towards more women and right‐sided strokes in treatment group Exclusion criteria: MMSE < 20, more than mild communication deficit, diseases of the central nervous system and previous neurodegenerative or expansive neurological disorders
Interventions	Treatment: fluoxetine 20 mg daily, dose escalation at 4 weeks if HDRS score > 13 Control: matched placebo Duration of treatment: 12 weeks Duration of follow‐up (end of treatment to study end): 15 months
Outcomes	Depression: change in scores from baseline to end of treatment of HDRS, BDI and CGI (item 1) Proportion of responders (< 13 HDRS) Additional: SSS Death AEs (selected data) Unable to use: RS, BI, MMSE (data not presented at follow‐up) AEs data on dizziness, nausea and cephalalgia (data not presented by group)
Funding source	The medication was supplied by Lannacher Heilmittel, Lannach, Austria
Notes	Recruitment 1 June 1998 to 31 Decmeber 1998. Conflicts of interest not stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computerised randomisation, using random permutated block design
Allocation concealment (selection bias)	Low risk	Centralised concealment
Blinding of participants and personnel (performance bias) All outcomes	Low risk	States blinded, used matching placebo
Blinding of outcome assessment (detection bias) All outcomes	Low risk	States blinded
Incomplete outcome data (attrition bias) All outcomes	High risk	4/54, per protocol analysis
Selective reporting (reporting bias)	Unclear risk	No protocol
Other bias	Unclear risk	Baseline balanced All participants were randomly assigned to either fluoxetine or placebo treatment by the drug company independently of the research teams and the study centres