Methods/Design: PRoMPT (PRimary care Monitoring for depressive Patients Trial) is a cluster
randomised controlled trial with General Practice (GP) as the unit of randomisation. The aim of
the study is to evaluate a GP applied case-management for patients with major depressive disorder.
70 GPs were randomised either to intervention group or to control group with the control group
delivering usual care. Each GP will include 10 patients suffering from major depressive disorder
according to the DSM-IV criteria. The intervention group will receive treatment based on
standardized guidelines and monthly telephone monitoring from a trained practice nurse. The
nurse investigates the patient's status concerning the MDD criteria, his adherence to GPs
prescriptions, possible side effects of medication, and treatment goal attainment. The control group
receives usual care – including recommended guidelines. Main outcome measure is the cumulative
score of the section depressive disorders (PHQ-9) from the German version of the Prime MD