Maintenance treatment with paroxetine, but not psychotherapy, prevented recurrent major depression in older persons.

M e t h o d s Design: Randomized, 2 × 2 factorial design, placebo-controlled trial. Allocation: {Concealed}†.* Blinding: Blinded (clinicians, patients, and outcome assessors).* Clinicians and patients were not blinded to the psychotherapy intervention. Follow-up period: 2 years. Setting: Specialized university-based clinic in Pittsburgh, Pennsylvania, USA. Patients: 116 patients ≥ 70 years of age (mean age 77 y, 65% women) who had major depression according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria, score ≥ 15 on the Hamilton Rating Scale for Depression (range 0 to 52 [worst]), score ≥ 17 on the Folstein Mini-Mental State Examination (range 0 to 30 [best]), and a sustained clinical response after several months of treatment with paroxetine, 10 to 40 mg/d, and psychotherapy (weekly, then biweekly). Intervention: Paroxetine plus psychotherapy (n = 28), paroxetine plus clinical care (n = 35), placebo plus psychotherapy (n = 35), or placebo plus clinical care (n = 18) for 2 years. Paroxetine was continued at the individually titrated dose. Psychotherapy or clinical care was provided monthly by the same clinician (nurse, social worker, or psychologist) who previously treated the patient. Outcomes: Recurrence of major depression, according to DSM-IV criteria and a Hamilton score ≥ 15, confirmed by a geriatric psychiatrist. Patient follow-up: 81% of patients completed the study (100% included in the intention-to-treat survival analysis).