Citalopram in Treating Postmenopausal Women With Hot Flashes

Phase 3

Completed

• Conditions: Psychosocial Effects of Cancer and Its Treatment; Hot Flashes; Breast Cancer
• Interventions: Drug: citalopram hydrobromide; Other: placebo

• Registration Number: NCT00363909
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* Evaluate the efficacy of three different doses of citalopram hydrobromide on hot flash scores in postmenopausal women with a history of breast cancer or in postmenopausal women who do not wish to take estrogen replacement therapy for fear of increased risk of breast cancer.

Secondary

* Compare the side effect profile of these regimens in these patients.

* Compare the effects of these regimens on the secondary outcome of mood and interference with activities from hot flashes.

* Determine if CYP2C19 and CYP2D6 polymorphisms predict efficacy of various doses of citalopram hydrobromide.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (18-49 years vs ≥ 50 years), tamoxifen (yes vs no), selective estrogen-receptor modulators (SERMs) (yes vs no), aromatase inhibitors (yes vs no), duration of hot flashes (\< 9 months vs ≥ 9 months), and frequency of hot flashes per day (\< 4 vs 4-9 vs ≥ 10). Patients are randomized to 1 of 4 treatment arms.

* Arm I (low-dose citalopram hydrobromide): Patients receive 1 tablet of oral citalopram once daily in weeks 2-7.

* Arm II (medium-dose citalopram hydrobromide): Patients receive 1 tablet of oral citalopram once daily in week 2 and 2 tablets once daily in weeks 3-7.

* Arm III (high-dose citalopram hydrobromide): Patients receive 1 tablet of oral citalopram once daily in week 2, 2 tablets once daily in week 3, and 3 tablets once daily in weeks 4-7.

* Arm IV (placebo): Patients receive 1-3 placebo tablets 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.

A Symptom Experience diary is completed weekly and Profile of Mood States and Hot Flash-Related Interference Scale questionnaires are completed at baseline and in week 7.

Study Timeline

• Study First Submitted: 2006-08-10
• Study First Submitted QC: 2006-08-10
• Study First Posted: 2006-08-15
• Study Start: 2006-11
• Primary Completion: 2007-06
• Study Completion: 2010-12
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-09
• Last Update Posted: 2016-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 254

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low-dose citalopram hydrobromide	citalopram hydrobromide	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.
high-dose citalopram hydrobromide	citalopram hydrobromide	Patients receive 1 tablet of oral citalopram once daily in week 2, 2 tablets once daily in week 3, and 3 tablets once daily in weeks 4-7. 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.
placebo	placebo	Patients receive 1-3 placebo tablets 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.
medium-dose citalopram hydrobromide	citalopram hydrobromide	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.

Primary Outcome Measures

Name	Time	Method
Difference in average hot flash score from baseline until week 7 of treatment	Up to 7 weeks

Secondary Outcome Measures

Name	Time	Method
Toxicity	Up to 7 weeks
Mood- and hot flash-related daily interference with activities	Up to 7 weeks

Trial Locations

Locations (195)

MBCCOP - Medical College of Georgia Cancer Center; 🇺🇸 Augusta, Georgia, United States

Rush-Copley Cancer Care Center; 🇺🇸 Aurora, Illinois, United States

St. Joseph Medical Center; 🇺🇸 Bloomington, Illinois, United States

Graham Hospital; 🇺🇸 Canton, Illinois, United States

Memorial Hospital; 🇺🇸 Carthage, Illinois, United States

Eureka Community Hospital; 🇺🇸 Eureka, Illinois, United States

Galesburg Clinic; 🇺🇸 Galesburg, Illinois, United States

Galesburg Cottage Hospital; 🇺🇸 Galesburg, Illinois, United States

Mason District Hospital; 🇺🇸 Havana, Illinois, United States

Hopedale Medical Complex; 🇺🇸 Hopedale, Illinois, United States

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