NCT00967408.
Methods | Study type: interventional (clinical trial) Estimated enrolment: 200 participants Allocation: randomised Intervention model: parallel assignment Masking: quadruple (participant, care provider, investigator, outcomes assessor) Primary purpose: treatment |
Participants | Country: Italy Setting: inpatient Inclusion criteria
Exclusion criteria
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Interventions | Experimental: escitalopram and rehabilitation. Escitalopram given 5 mg once a day for the first week, 10 mg once a day from the second to fourth week, and 20 mg daily until the 6th month Comparator: placebo and rehabilitation |
Outcomes | Primary outcome collected at 2 and 6 months
Secondary outcomes collected at 2 and 6 months:
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Notes | clinicaltrials.gov/ct2/show/NCT00967408 Contacted author Prof Cisari; response received; data being analysed |
BDI: Beck Depression Inventory BI: Bathel Index FIM: Functional Independence Measure HAM‐D17: Hamilton Depression Scale ICD‐10: International Statistical Classification of Diseases, 10th revision IQR: interquartile range MMSE: Mini‐Mental State Examination NIHSS: National Institutes of Health Stroke Scale