BACKGROUNDBased on data from large multicentre US trials, the National Institute for Health and Clinical Excellence (NICE) is advocating a stepped-care model for the management of depression, with 'case management' or 'collaborative care' for selected patients in primary care.AIMTo conduct a pilot study examining the use of graduate mental health workers case managing depressed primary care NHS patients.DESIGN OF STUDYA randomised controlled trial comparing usual GP care with or without case management over 16 weeks of acute antidepressant drug treatment.SETTINGThree primary care practices in the North East of England.METHODPatients with depression, aged 18-65 years, who had failed to adequately respond to antidepressant treatment, were randomised to the two treatments. Assessments were made at baseline, 12, and 24 weeks using a combination of observer and self ratings.RESULTSRandomisation of 62 patients required screening of 1073 potential patients. There was little difference in outcome between the two treatment arms but a gradual improvement in symptoms over time was seen. Client satisfaction was assessed as high across both treatments.CONCLUSIONWhile this pilot study confirmed the integrity of the study protocol and the suitability of the outcome measures and randomisation procedure, it raises questions regarding the practicality of recruitment and feasibility of the intervention. It would be crucial to address these issues prior to the implementation of a large multi-centre randomised controlled trial.