The use of pindolol with fluoxetine in the treatment of major depression: Final results from a double-blind, placebo-controlled trial

Background: Preliminary reports have suggested that concomitant institution of pindolol and serotonin reuptake inhibitors robustly hastens clinical re sponse; however, contradictory evidence from a randomized double-blind, con trolled trial was recently reported by this group in a population of depres sed patients who were prescribed fluxoetine and pindolol. Herein, we report final results from an extended sample size. Methods: Drug-free outpatients with a major depressive episode were randomi zed in a double-blind manner to one of two treatment conditions: fluoxetine (20 mg daily) with pindolol (7.5 to 10 mg daily) or fluoxetine (20 mg dail y) with placebo. After 6 weeks, patients were followed for 3 more,weeks in a single-blind manner, on fluoxetine and placebo pindolol. Results: Eighty-six patients completed at least 1 or more weeks on protocol , with 45 and 41 patients randomized to the pindolol and placebo groups res pectively. After 2 weeks on protocol, partial remission (i.e., at least 50% decrease in depression rating scores from baseline) rates for pindolol (16 %) and placebo (19%) groups were comparable. By the study's end, a partial remission was achieved at least transiently for 67% of the pindolol group a nd 80% of the placebo group. Pindolol treatment was associated with statist ically significant reduction in blood pressure and pulse as compared to the control group. The two groups did not have overall differences in rates of attrition, time to response, and side effects. Conclusions: In accord with our previously published findings, these extend ed results do nor support the efficacy of pindolol in hastening clinical re sponse to fluoxetine in a patient population with predominantly chronic and recurrent depression. (C) 1999 Society of Biological Psychiatry.