Clinical trial · Interventional
Citalopram in Treating Postmenopausal Women With Hot Flashes
Phase III Randomized, Double-Blind, Placebo-Controlled Evaluation of Citalopram for the Treatment of Hot Flashes
NCT00363909CI-TRIAL-00025128completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Citalopram may help relieve hot flashes in women who had or have not had breast cancer. It is not yet known which dose of citalopram is more effective in treating hot flashes in postmenopausal women. PURPOSE: This randomized phase III trial is studying three different doses of citalopram to compare how well they work in treating postmenopausal women with hot flashes.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hot Flashes | — | UNRESOLVED | — |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| citalopram hydrobromide | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- low-dose citalopram hydrobromide
- description
- Patients receive 1 tablet of oral citalopram once daily in weeks 2-7. All patients complete a diary of hot flash incidence in weeks 1-7 and undergo blood collection periodically during study treatment for translational research studies.
- interventionNames
- Drug: citalopram hydrobromide
- type
- EXPERIMENTAL
- label
- medium-dose citalopram hydrobromide
- description
- Patients receive 1 tablet of oral citalopram once daily in week 2 and 2 tablets once daily in weeks 3-7. All patients complete a diary of hot flash incidence in weeks 1-7 and undergo blood collection periodically during study treatment for translational research studies.
- interventionNames
- Drug: citalopram hydrobromide
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 periodReferences
Publications (2)
- RESULTBarton DL, LaVasseur BI, Sloan JA, Stawis AN, Flynn KA, Dyar M, Johnson DB, Atherton PJ, Diekmann B, Loprinzi CL. Phase III, placebo-controlled trial of three doses of citalopram for the treatment of hot flashes: NCCTG trial N05C9. J Clin Oncol. 2010 Jul 10;28(20):3278-83. doi: 10.1200/JCO.2009.26.6379. Epub 2010 May 24. PMID 20498389
- RESULTBarton DL, LaVasseur B, Sloan JA, et al.: A phase III trial evaluating three doses of citalopram for hot flashes: NCCTG trial N05C9. [Abstract] J Clin Oncol 26 (Suppl 15): A-9538, 2008.