Razazian 2014.

Methods	Study type: interventional (clinical trial) Primary purpose: treatment
Participants	172 participants Country: Iran (Islamic Republic of) Setting: inpatient At randomisation number allocated: fluoxetine n = 86; placebo n = 86 % male: unclear Age: fluoxetine group = unclear; placebo = unclear Subtype of stroke: not available Severity of stroke: not available Time since stroke onset: not available Inclusion criteria Middle cerebral artery stroke (documented with imaging) Hemiplegia, monoplegia or paresis No coma Consent Suitable for discharge Not admitted to Intensive care unit Exclusion criteria Death from any cause during study Irregular use of drugs Irregular return for re‐examinations Seizures Severe diarrhoea, vomiting, Severe insomnia Metabolic disorder History of psychiatric disorder or severe depression prior to stroke SAH, lobar ICH, brain tumour or stroke in other vascular territories Use of any MAOI, selegiline, cyproheptadine Withdrawal criteria: not stated
Interventions	Experimental: fluoxetine, 20 mg once a day for 90 days Comparator: placebo fluoxetine for 90 days All participants received 30 sessions of routine physiotherapy during the rehabilitation period
Outcomes	Primary outcomes collected at day 45 and day 90 Motor deficit (BI) Psychiatric disorder (HDRS)
Funding source	Kermanshah University of Medical Sciences.
Notes	IRCT201312088323N7 Baseline demographic and clinical characteristics for each group not presented, but rather the baseline demographic and clinical characteristics for those completing the trial (i.e. a subset of all those randomised at baseline) are presented Dates study conducted: participants recruited between June 2013 and September 2014 Declarations of Interest: none reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "random permuted blocks". Comment: Insufficient information about the block randomisation to permit judgement
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement of yes or no
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "placebo that was identical to the active drug in appearance and packaging"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgement of yes or no
Incomplete outcome data (attrition bias) All outcomes	High risk	13% attrition at 90 days. 13% (n = 11/86) from the experimental group and 13% (n = 11/86) from the comparator group were excluded form the full set analysis at 90 days follow‐up. Reasons for attrition reported
Selective reporting (reporting bias)	Low risk	Protocol available and all the study's prespecified outcomes that are of interest to the review have been reported in a prespecified way
Other bias	High risk	The baseline data presented in table 1: patients demographic characteristics and risk factors and not true baseline characteristics (i.e. at randomisation). The data presented in table 1 are the characteristics of the full analysis set which is a subgroup of all participants randomised. We cannot tell if there is whether there was any baseline imbalance in important demographic or clinical characteristics