Time to relapse after short- or long-term treatment of severe premenstrual syndrome with sertraline.

Context: The duration of treatment after achieving a satisfactory response is unknown in the treatment of premenstrual syndrome. This information is needed in view of the improvement provided by medication vs the adverse effects and costs of drugs.

Objective: To compare rates of relapse and time to relapse between short- and long-term treatment with sertraline hydrochloride administered in the luteal phase of the menstrual cycle.

Design: Eighteen-month survival study with a randomized double-blind switch to placebo after 4 or 12 months of sertraline treatment.

Setting: Academic medical center.

Participants: One hundred seventy-four patients with premenstrual syndrome or premenstrual dysphoric disorder.

Main Outcome Measure: Relapse, defined as symptoms returning to the entry criterion level as assessed with daily ratings.

Results: The relapse rate was 41% during long-term treatment compared with 60% after short-term sertraline therapy, with a median time to relapse of 8 months vs 4 months (hazard ratio, 0.58; 95% confidence interval, 0.34-0.98; P = .04). Patients with severe symptoms at baseline were more likely to experience relapse compared with patients in the lower symptom severity group (hazard ratio, 2.02; 95% confidence interval, 1.18-3.41; P = .01) and were more likely to experience relapse with short-term treatment (P = .03). Duration of treatment did not affect relapse in patients in the lower symptom severity group (P = .50). Patients who demonstrated remission were least likely to experience relapse (hazard ratio, 0.22; 95% confidence interval, 0.10-0.45; P < .001). Further analysis comparing relapse in the first 6 months of placebo treatment in each group yielded similar results.

Conclusions: The relapse rate was significantly greater after short-term treatment compared with long-term treatment. The relapse rate was also high during extended drug treatment. Subjects with severe symptoms at baseline were most likely to experience relapse, and relapse occurred more swiftly regardless of treatment duration. These findings suggest that the severity of symptoms at baseline and symptom remission with treatment should be considered in determining the duration of treatment.

Trial Registration: clinicaltrials.gov Identifier: NCT00318773.