Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2010 Jul 10;28(20):3278-83.
doi: 10.1200/JCO.2009.26.6379. Epub 2010 May 24.

Phase III, placebo-controlled trial of three doses of citalopram for the treatment of hot flashes: NCCTG trial N05C9

Debra L Barton  1 , Beth I LaVasseur, Jeff A Sloan, Allen N Stawis, Kathleen A Flynn, Missy Dyar, David B Johnson, Pamela J Atherton, Brent Diekmann, Charles L Loprinzi
Affiliations
Clinical Trial

Phase III, placebo-controlled trial of three doses of citalopram for the treatment of hot flashes: NCCTG trial N05C9

Debra L Barton et al. J Clin Oncol. .

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 <or= .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.

PubMed Disclaimer

Conflict of interest statement

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Figures

Fig 1.
Fig 1.
CONSORT diagram.
Fig 2.
Fig 2.
Hot flash score percent reduction (mean daily reduction).
Fig 3.
Fig 3.
Hot flash frequency percent reduction (mean daily reduction).
See this image and copyright information in PMC

Comment in

References

    1. Carpenter JS, Andrykowski MA. Menopausal symptoms in breast cancer survivors. Oncol Nurs Forum. 1999;26:1311–1317. - PubMed
    1. Couzi RJ HK, Fetting JH. Prevalence of menopausal symptoms among women with a history of breast cancer and attitudes toward estrogen replacement therapy. J Clin Oncol. 1995;13:2737–2744. - PubMed
    1. Gracia CR, Freeman EW. Acute consequences of the menopausal transition: The rise of common menopausal symptoms. Endocrinol Metab Clin North Am. 2004;33:675–689. - PubMed
    1. Stearns V, Ullmer L, Lopez JF, et al. Hot flushes. Lancet. 2002;360:1851–1861. - PubMed
    1. Carpenter JS, Johnson D, Wagner L, et al. Hot flashes and related outcomes in breast cancer survivors and matched comparison women. Oncol Nurs Forum. 2002;29:E16–25. - PubMed

Publication types

MeSH terms