TY - JOUR
T1 - The use of pindolol with fluoxetine in the treatment of major depression
T2 - Final results from a double-blind, placebo-controlled trial
AU - Berman, Robert M.
AU - Anand, Amit
AU - Cappiello, Angela
AU - Miller, Helen L.
AU - Hu, X. Sylvia
AU - Oren, Dan A.
AU - Charney, Dennis S.
N1 - Funding Information:
This work was supported in part by a Young Investigators Award from the National Alliance for Research in Schizophrenia and Depression #727R-41-55315 (RMB); a Merit Review Grant from the Department of Veterans Affairs (DSC); and a grant from Eli Lilly, Inc.
PY - 1999/5
Y1 - 1999/5
N2 - Background: Preliminary reports have suggested that concomitant institution of pindolol and serotonin reuptake inhibitors robustly hastens clinical response; however, contradictory evidence from a randomized double- blind, controlled trial was recently reported by this group in a population of depressed patients who were prescribed fluoxetine and pindolol. Herein, we report final results from an extended sample size. Methods: Drug-free outpatients with a major depressive episode were randomized 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 daily) 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 respectively. 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 and 80% of the placebo group. Pindolol treatment was associated with statistically 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 extended results do not support the efficacy of pindolol in hastening clinical response to fluoxetine in a patient population with predominantly chronic and recurrent depression.
AB - Background: Preliminary reports have suggested that concomitant institution of pindolol and serotonin reuptake inhibitors robustly hastens clinical response; however, contradictory evidence from a randomized double- blind, controlled trial was recently reported by this group in a population of depressed patients who were prescribed fluoxetine and pindolol. Herein, we report final results from an extended sample size. Methods: Drug-free outpatients with a major depressive episode were randomized 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 daily) 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 respectively. 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 and 80% of the placebo group. Pindolol treatment was associated with statistically 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 extended results do not support the efficacy of pindolol in hastening clinical response to fluoxetine in a patient population with predominantly chronic and recurrent depression.
KW - Controlled trial
KW - Fluoxetine
KW - Pindolol
KW - Serotonin receptors
UR - http://www.scopus.com/inward/record.url?scp=0033135316&partnerID=8YFLogxK
U2 - 10.1016/S0006-3223(98)00383-7
DO - 10.1016/S0006-3223(98)00383-7
M3 - Article
C2 - 10331109
AN - SCOPUS:0033135316
SN - 0006-3223
VL - 45
SP - 1170
EP - 1177
JO - Biological Psychiatry
JF - Biological Psychiatry
IS - 9
ER -