TY - JOUR
T1 - Phase II evaluation of desipramine for the treatment of hot flashes
AU - Barton, Debra L.
AU - Loprinzi, Charles L.
AU - Atherton, Pamela
AU - Raymond, Jane
AU - Shanafelt, Tait
AU - Hines, Stephanie
AU - Palmieri, Fran
AU - Rummans, Teresa
AU - Adjei, Alex A.
AU - Sloan, Jeff
N1 - Funding Information:
This study was supported by a grant from the Susan G. Komen Foundation.
PY - 2007/9
Y1 - 2007/9
N2 - Purpose: Newer antidepressants with serotonergic effects reduce hot flashes significantly better than placebo. This pilot study was designed to test the efficacy of desipramine, an older antidepressant targeting norepinephrine, in women desiring therapy for hot flashes and to evaluate the toxicity of desipramine. Patients and Methods: In this nonrandomized trial, eligible women were required to have reported ≥ 14 bothersome hot flashes per week for ≥ 1 month. After an initial baseline week in which no study medication was taken, participants started with desipramine 25 mg daily, which was titrated to 100 mg daily by week 5. The primary endpoint was change from baseline in hot flash frequency and hot flash score. Statistical methods involved paired t tests for continuous variables and Fisher exact tests for categoric variables. Results: Twenty-six patients were enrolled on this study between March 2004 and November 2005. The decrease in mean hot flash frequency over 4 weeks of treatment was 23%, with a 31% reduction in hot flash scores. Seven patients (30%) withdrew early because of toxicities consisting of insomnia, nausea, headaches, and/or feeling frightened. Conclusion: Desipramine did not reduce hot flashes beyond the 25%-30% reduction that would be expected with placebo, based on previous work. Therefore, data from this trial do not support further study of this agent for treatment of hot flashes. It is of physiologic interest that this older antidepressant, classified as a tricyclic, did not achieve a clinically significant reduction in hot flash scores in this pilot trial.
AB - Purpose: Newer antidepressants with serotonergic effects reduce hot flashes significantly better than placebo. This pilot study was designed to test the efficacy of desipramine, an older antidepressant targeting norepinephrine, in women desiring therapy for hot flashes and to evaluate the toxicity of desipramine. Patients and Methods: In this nonrandomized trial, eligible women were required to have reported ≥ 14 bothersome hot flashes per week for ≥ 1 month. After an initial baseline week in which no study medication was taken, participants started with desipramine 25 mg daily, which was titrated to 100 mg daily by week 5. The primary endpoint was change from baseline in hot flash frequency and hot flash score. Statistical methods involved paired t tests for continuous variables and Fisher exact tests for categoric variables. Results: Twenty-six patients were enrolled on this study between March 2004 and November 2005. The decrease in mean hot flash frequency over 4 weeks of treatment was 23%, with a 31% reduction in hot flash scores. Seven patients (30%) withdrew early because of toxicities consisting of insomnia, nausea, headaches, and/or feeling frightened. Conclusion: Desipramine did not reduce hot flashes beyond the 25%-30% reduction that would be expected with placebo, based on previous work. Therefore, data from this trial do not support further study of this agent for treatment of hot flashes. It is of physiologic interest that this older antidepressant, classified as a tricyclic, did not achieve a clinically significant reduction in hot flash scores in this pilot trial.
KW - Antidepressants
KW - Menopause
KW - Survivors
KW - Symptom management
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U2 - 10.3816/SCT.2007.n.018
DO - 10.3816/SCT.2007.n.018
M3 - Article
C2 - 18632520
AN - SCOPUS:35348962753
SN - 1543-2912
VL - 4
SP - 219
EP - 224
JO - Supportive Cancer Therapy
JF - Supportive Cancer Therapy
IS - 4
ER -