Background: Depression in women is one of the commonest problems encountered in primary care. We aimed to compare the effectiveness of a stepped-care programme with usual care in primary-care management of depression in low-income women in Santiago, Chile. Methods: In a randomised controlled trial, in three primary-care clinics in Chile, 240 adult female primary-care patients with major depression were allocated stepped care or usual care. Stepped care was a 3-month, multicomponent intervention led by a non-medical health worker, which included a psychoeducational group intervention, structured and systematic follow-up, and drug treatment for patients with severe depression. Data were analysed on an intention-to-treat basis. The primary outcome measure was the Hamilton depression rating scale (HDRS) administered at baseline and at 3 and 6 months after randomisation. Findings: About 90% of randomised patients completed outcome assessments. There was a substantial between-group differenc