Phase III, placebo-controlled trial of three doses of citalopram for the treatment of hot flashes

NCCTG trial N05C9

Debra L. Barton, Beth I. LaVasseur, Jeff A Sloan, Allen N. Stawis, Kathleen A. Flynn, Missy Dyar, David B. Johnson, Pamela J. Atherton, Brent Diekmann, Charles Lawrence Loprinzi

Research output: Contribution to journalArticle

76 Citations (Scopus)

Abstract

Purpose: Up to 75% of women experience hot flashes, which can negatively impact quality of life. As hot flash physiology is not definitively understood, it cannot be assumed that effective agents represent class effects. Therefore, there is a continued need for rigorous evaluation to identify effective nonhormonal options for hot flash relief. Methods: A randomized, double-blind trial evaluated citalopram at target doses of 10, 20, or 30 mg/d versus placebo for 6 weeks. Postmenopausal women with at least 14 bothersome hot flashes per week recorded hot flashes for 7 days before starting treatment and were then titrated to their target doses. The primary end point was the change from baseline to 6 weeks in hot flash score. Results: Two hundred fifty-four women were randomly assigned onto this study. Data for hot flash scores and frequencies showed significant improvement in hot flashes with citalopram over placebo, with no significant differences among doses. Reductions in mean hot flash scores were 2.0 (23%), 7.0 (49%), 7.7 (50%), and 10.7 (55%) for placebo and 10, 20, and 30 mg of citalopram, respectively (P ≤ .002). Improvement in secondary outcomes, such as the Hot Flash Related Daily Interference Scale, was statistically superior in the 20-mg arm. Citalopram was well-tolerated, with no significant negative adverse effects. Conclusion: Citalopram is an effective, well-tolerated agent in managing hot flashes. There does not appear to be a significant dose response above 10 mg/d, but broader helpful effects of the agent appear to be more evident at 20 mg/d.

Original languageEnglish (US)
Pages (from-to)3278-3283
Number of pages6
JournalJournal of Clinical Oncology
Volume28
Issue number20
DOIs
StatePublished - Jul 10 2010

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Hot Flashes
Citalopram
Placebos
Therapeutics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

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Phase III, placebo-controlled trial of three doses of citalopram for the treatment of hot flashes : NCCTG trial N05C9. / Barton, Debra L.; LaVasseur, Beth I.; Sloan, Jeff A; Stawis, Allen N.; Flynn, Kathleen A.; Dyar, Missy; Johnson, David B.; Atherton, Pamela J.; Diekmann, Brent; Loprinzi, Charles Lawrence.

In: Journal of Clinical Oncology, Vol. 28, No. 20, 10.07.2010, p. 3278-3283.

Research output: Contribution to journalArticle

Barton, DL, LaVasseur, BI, Sloan, JA, Stawis, AN, Flynn, KA, Dyar, M, Johnson, DB, Atherton, PJ, Diekmann, B & Loprinzi, CL 2010, 'Phase III, placebo-controlled trial of three doses of citalopram for the treatment of hot flashes: NCCTG trial N05C9', Journal of Clinical Oncology, vol. 28, no. 20, pp. 3278-3283. https://doi.org/10.1200/JCO.2009.26.6379
Barton, Debra L. ; LaVasseur, Beth I. ; Sloan, Jeff A ; Stawis, Allen N. ; Flynn, Kathleen A. ; Dyar, Missy ; Johnson, David B. ; Atherton, Pamela J. ; Diekmann, Brent ; Loprinzi, Charles Lawrence. / Phase III, placebo-controlled trial of three doses of citalopram for the treatment of hot flashes : NCCTG trial N05C9. In: Journal of Clinical Oncology. 2010 ; Vol. 28, No. 20. pp. 3278-3283.
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T1 - Phase III, placebo-controlled trial of three doses of citalopram for the treatment of hot flashes

T2 - NCCTG trial N05C9

AU - Barton, Debra L.

AU - LaVasseur, Beth I.

AU - Sloan, Jeff A

AU - Stawis, Allen N.

AU - Flynn, Kathleen A.

AU - Dyar, Missy

AU - Johnson, David B.

AU - Atherton, Pamela J.

AU - Diekmann, Brent

AU - Loprinzi, Charles Lawrence

PY - 2010/7/10

Y1 - 2010/7/10

N2 - Purpose: Up to 75% of women experience hot flashes, which can negatively impact quality of life. As hot flash physiology is not definitively understood, it cannot be assumed that effective agents represent class effects. Therefore, there is a continued need for rigorous evaluation to identify effective nonhormonal options for hot flash relief. Methods: A randomized, double-blind trial evaluated citalopram at target doses of 10, 20, or 30 mg/d versus placebo for 6 weeks. Postmenopausal women with at least 14 bothersome hot flashes per week recorded hot flashes for 7 days before starting treatment and were then titrated to their target doses. The primary end point was the change from baseline to 6 weeks in hot flash score. Results: Two hundred fifty-four women were randomly assigned onto this study. Data for hot flash scores and frequencies showed significant improvement in hot flashes with citalopram over placebo, with no significant differences among doses. Reductions in mean hot flash scores were 2.0 (23%), 7.0 (49%), 7.7 (50%), and 10.7 (55%) for placebo and 10, 20, and 30 mg of citalopram, respectively (P ≤ .002). Improvement in secondary outcomes, such as the Hot Flash Related Daily Interference Scale, was statistically superior in the 20-mg arm. Citalopram was well-tolerated, with no significant negative adverse effects. Conclusion: Citalopram is an effective, well-tolerated agent in managing hot flashes. There does not appear to be a significant dose response above 10 mg/d, but broader helpful effects of the agent appear to be more evident at 20 mg/d.

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