Phase III Randomized, Double-Blind, Placebo-Controlled Evaluation of Citalopram for the Treatment of Hot Flashes

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Must meet 1 of the following criteria:

- History of breast cancer

- No current malignant disease

- No history of breast cancer and refused estrogen replacement therapy due to
perceived increased risk of breast cancer

- Bothersome hot flashes, defined as hot flashes ≥ 14 times/week and of sufficient
severity to make the patient desire therapeutic intervention

- Presence of hot flashes ≥ 1 month prior to study entry

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Female

- Postmenopausal, as defined by 1 of the following criteria:

- Absence of a menstrual period in the past 12 months

- Bilateral oophorectomy

- Absence of a menstrual period in the past 6 months with follicle-stimulating
hormone (FSH) level > 40 mIU/mL

- ECOG performance status 0-1

- Life expectancy ≥ 6 months

- Willing to provide blood samples during study participation

- No history of allergic or other adverse reactions to citalopram hydrobromide or other
selective serotonin reuptake inhibitors (SSRIs)

- No documented mania or hypomania

PRIOR CONCURRENT THERAPY:

- At least 4 weeks since prior and no concurrent antineoplastic chemotherapy

- At least 4 weeks since prior and no concurrent androgens, estrogens, or
progestational agents

- At least 3 months since prior antidepressant use, including Hypericum perforatum (St.
John's wort)

- Concurrent tamoxifen, raloxifene, or aromatase inhibitors allowed if on a constant
dose for ≥ 4 weeks and continuing medication during study period

- No other concurrent or planned agents for treating hot flashes (e.g., phenobarbital,
megestrol, or clonidine)

- Stable dose of vitamin E allowed as long as it was started > 30 days prior to
study entry

- Concurrent soy allowed

- Concurrent gabapentin allowed for reasons other than hot flashes if on a constant
dose for ≥ 1 month and continuing during study period