Sitzer 2002.

Study name	Prevention of poststroke depression after acute ischemic stroke using the selective serotonine reuptake inhibitor sertraline: "PreDIS‐Study"
Methods	Study design: parallel design Number of arms: 2 Treatment arm: sertraline (SSRI) Control arm: matched placebo
Participants	Geographical location: Germany Setting: mixed Stroke criteria: unilateral ischaemic stroke Method of stroke diagnosis: unclear Time since stroke: 3 to 6 days prior to randomisation Inclusion criteria: unclear Exclusion criteria: 1) early and complete recovery from neurological symptoms; 2) mechanically ventilated for more than 2 days; 3) severe aphasia or dementia; 4) already on antidepressant Depression criteria: none Total number randomised in this trial: unclear Number randomised in treatment group: unclear Number randomised to control group: unclear Total number included in final analysis: unclear Number included in treatment group for final analysis: unclear Number included in control group for final analysis: unclear
Interventions	Treatment: sertraline (SSRI) 25 mg per day for the first week and 50 mg per day for the rest of the study Control: matched placebo Treatment duration: treatment to continue for 6 months Follow‐up: unclear
Outcomes	Primary outcomes Depression measured using the HADS, MADRS and ICD‐10 diagnostic criteria Secondary outcomes Activities of daily living measured using the BI Functional capacity measured using the mRS Cognitive function measured using the MMSE Impairment measured using the European Stroke Scale Quality of life measured using the SF‐36
Starting date	August 2001
Contact information	Dr. Matthias Sitzer, Zentrum der Neurologie und Neurochirurgie JW Goethe‐Universitat Frankfurt am Main Schleusenweg 2‐16 D‐60528 Frankfurt am Main Germany, E: sitzer@em.uni-frankfurt.de
Notes

BI: Barthel Index

GHQ‐28: 28‐item General Health Questionnaire

HADS: Hospital Anxiety and Depression Scale

ICD‐10: International Classification of Disease‐ 10

MADRS: Montgomery Asberg Depression Rating Scale

MMSE: Mini Mental State Examination

mRS: modified Rankin Scale

OT: occupational therapist

RN: registered nurse

SAQOL‐39: 39‐item Stroke Aphasia Quality of Life Scale

SF‐36: 36‐item Short Form Questionnaire

SOC‐13: 13‐item Sense of Coherence Scale

SSRI: selective serotonin reuptake inhibitors