Citalopram in Treating Postmenopausal Women With Hot Flashes

December 9, 2016 updated by: Alliance for Clinical Trials in Oncology

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

254

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Augusta, Georgia, United States, 30912
        • MBCCOP - Medical College of Georgia Cancer Center
    • Illinois
      • Aurora, Illinois, United States, 60507
        • Rush-Copley Cancer Care Center
      • Bloomington, Illinois, United States, 61701
        • St. Joseph Medical Center
      • Canton, Illinois, United States, 61520
        • Graham Hospital
      • Carthage, Illinois, United States, 62321
        • Memorial Hospital
      • Eureka, Illinois, United States, 61530
        • Eureka Community Hospital
      • Galesburg, Illinois, United States, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, United States, 61401
        • Galesburg Clinic
      • Havana, Illinois, United States, 62644
        • Mason District Hospital
      • Hopedale, Illinois, United States, 61747
        • Hopedale Medical Complex
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates, Limited - West
      • Kewanee, Illinois, United States, 61443
        • Kewanee Hospital
      • Macomb, Illinois, United States, 61455
        • McDonough District Hospital
      • Normal, Illinois, United States, 61761
        • BroMenn Regional Medical Center
      • Normal, Illinois, United States, 61761
        • Community Cancer Center
      • Ottawa, Illinois, United States, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, United States, 61350
        • Oncology Hematology Associates of Central Illinois, PC - Ottawa
      • Pekin, Illinois, United States, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Peoria, Illinois, United States, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61614
        • Proctor Hospital
      • Peoria, Illinois, United States, 61637
        • OSF St. Francis Medical Center
      • Peoria, Illinois, United States, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, United States, 61615
        • Oncology Hematology Associates of Central Illinois, PC - Peoria
      • Peru, Illinois, United States, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, United States, 61356
        • Perry Memorial Hospital
      • Spring Valley, Illinois, United States, 61362
        • St. Margaret's Hospital
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Elkhart, Indiana, United States, 46515
        • Elkhart General Hospital
      • Kokomo, Indiana, United States, 46904
        • Howard Community Hospital at Howard Regional Health System
      • La Porte, Indiana, United States, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Michigan City, Indiana, United States, 46360
        • Saint Anthony Memorial Health Centers
      • Richmond, Indiana, United States, 47374
        • Reid Hospital & Health Care Services, Incorporated
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, United States, 46601
        • CCOP - Northern Indiana CR Consortium
      • South Bend, Indiana, United States, 46617
        • Saint Joseph Regional Medical Center
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic, PC
      • Cedar Rapids, Iowa, United States, 52403
        • Cedar Rapids Oncology Associates
      • Des Moines, Iowa, United States, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, United States, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, United States, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50307
        • Mercy Capitol Hospital
      • Des Moines, Iowa, United States, 50316-2301
        • John Stoddard Cancer Center
      • Mason City, Iowa, United States, 50401
        • Mercy Cancer Center at Mercy Medical Center - North Iowa
      • Ottumwa, Iowa, United States, 52501
        • McCreery Cancer Center at Ottumwa Regional
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, United States, 51104
        • St. Luke's Regional Medical Center
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Liberal, Kansas, United States, 67901
        • Southwest Medical Center
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, United States, 67042
        • Cancer Center of Kansas, PA - Salina
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, United States, 67203
        • Associates in Womens Health, PA - North Review
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, United States, 67214
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Hickman Cancer Center at Bixby Medical Center
      • Ann Arbor, Michigan, United States, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Dearborn, Michigan, United States, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Escanaba, Michigan, United States, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Iron Mountain, Michigan, United States, 49801
        • Dickinson County Healthcare System
      • Jackson, Michigan, United States, 49201
        • Foote Hospital
      • Lambertville, Michigan, United States, 48144
        • Haematology-Oncology Associates of Ohio and Michigan, PC
      • Lansing, Michigan, United States, 48909
        • Sparrow Regional Cancer Center
      • Monroe, Michigan, United States, 48162
        • Community Cancer Center of Monroe
      • Monroe, Michigan, United States, 48162
        • Mercy Memorial Hospital System
      • Saginaw, Michigan, United States, 48601
        • Seton Cancer Institute - Saginaw
      • St. Joseph, Michigan, United States, 49085
        • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
      • Warren, Michigan, United States, 48093
        • St. John Macomb Hospital
    • Minnesota
      • Alexandria, Minnesota, United States, 56308
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Duluth, Minnesota, United States, 55805
        • CCOP - Duluth
      • Duluth, Minnesota, United States, 55805
        • St. Mary's - Duluth Clinic Cancer Center
      • Duluth, Minnesota, United States, 55805
        • Miller-Dwan Medical Center
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fergus Falls, Minnesota, United States, 56537
      • Fridley, Minnesota, United States, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Mankato, Minnesota, United States, 56002
        • Immanuel St. Joseph's Clinic
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology, PA at Maplewood Cancer Center
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
      • Montevideo, Minnesota, United States, 56265
        • Chippewa County - Montevideo Hospital
      • Robbinsdale, Minnesota, United States, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Medical Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, United States, 56303
        • Coborn Cancer Center
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
      • St. Cloud, Minnesota, United States, 56303
        • CentraCare Clinic - River Campus
      • St. Louis Park, Minnesota, United States, 55416
        • Park Nicollet Health Services
      • St. Paul, Minnesota, United States, 55102
        • United Hospital
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology, PA - Woodbury
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Arch Medical Services, Incorporated at Center for Cancer Care Research
      • St. Louis, Missouri, United States, 63131
        • Missouri Baptist Cancer Center
    • Montana
      • Billings, Montana, United States, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, United States, 59101
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Billings, Montana, United States, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, United States, 59101
        • St. Vincent Healthcare
      • Billings, Montana, United States, 59107-5100
        • Billings Clinic Cancer Center
      • Billings, Montana, United States, 59107-7000
        • Deaconess Billings Clinic - Downtown
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, United States, 59701
        • St. James Community Hospital
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic
      • Great Falls, Montana, United States, 59405
      • Helena, Montana, United States, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, United States, 59901
        • Glacier Oncology, PLLC
      • Kalispell, Montana, United States, 59901
        • Kalispell Medical Oncology
      • Missoula, Montana, United States, 59801
        • Community Medical Center
      • Missoula, Montana, United States, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, United States, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, United States, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Cancer Resource Center - Lincoln
      • Omaha, Nebraska, United States, 68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha, Nebraska, United States, 68122
        • Immanuel Medical Center
      • Omaha, Nebraska, United States, 68124
        • Alegant Health Cancer Center at Bergan Mercy Medical Center
      • Omaha, Nebraska, United States, 68131-2197
        • Creighton University Medical Center
    • North Carolina
      • Rutherfordton, North Carolina, United States, 28139
        • Rutherford Hospital
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, United States, 58501
        • Medcenter One Hospital Cancer Care Center
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic, PC
      • Bismarck, North Dakota, United States, 58502
        • St. Alexius Medical Center Cancer Center
    • Ohio
      • Bowling Green, Ohio, United States, 43402
        • Wood County Oncology Center
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Columbus, Ohio, United States, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health - West Hospital
      • Columbus, Ohio, United States, 43215
        • CCOP - Columbus
      • Columbus, Ohio, United States, 43228
        • Doctors Hospital at Ohio Health
      • Columbus, Ohio, United States, 43215
        • Grant Riverside Cancer Services
      • Dayton, Ohio, United States, 45428
        • Veterans Affairs Medical Center - Dayton
      • Dayton, Ohio, United States, 45405
        • Grandview Hospital
      • Dayton, Ohio, United States, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, United States, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, United States, 45429
        • CCOP - Dayton
      • Delaware, Ohio, United States, 43015
        • Grady Memorial Hospital
      • Findlay, Ohio, United States, 45840
        • Blanchard Valley Medical Associates
      • Fremont, Ohio, United States, 43420
        • Fremont Memorial Hospital
      • Kettering, Ohio, United States, 45429
        • Charles F. Kettering Memorial Hospital
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
      • Lima, Ohio, United States, 45804
        • Lima Memorial Hospital
      • Marietta, Ohio, United States, 45750
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Maumee, Ohio, United States, 43537
        • Northwest Ohio Oncology Center
      • Maumee, Ohio, United States, 43537
        • St. Luke's Hospital
      • Middletown, Ohio, United States, 45044
        • Middletown Regional Hospital
      • Newark, Ohio, United States, 43055
        • Licking Memorial Cancer Care Program at Licking Memorial Hospital
      • Oregon, Ohio, United States, 43616
        • St. Charles Mercy Hospital
      • Oregon, Ohio, United States, 43616
        • Toledo Clinic - Oregon
      • Sandusky, Ohio, United States, 44870
        • Firelands Regional Medical Center
      • Sandusky, Ohio, United States, 44870
        • North Coast Cancer Care, Incorporated
      • Springfield, Ohio, United States, 45505
        • Community Hospital of Springfield and Clark County
      • Springfield, Ohio, United States, 45504
        • Mercy Medical Center
      • Sylvania, Ohio, United States, 43560
        • Flower Hospital Cancer Center
      • Tiffin, Ohio, United States, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, United States, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, United States, 43606
        • Toledo Hospital
      • Toledo, Ohio, United States, 43614
        • Medical University of Ohio Cancer Center
      • Toledo, Ohio, United States, 43617
        • CCOP - Toledo Community Hospital
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Troy, Ohio, United States, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wauseon, Ohio, United States, 43567
        • Fulton County Health Center
      • Westerville, Ohio, United States, 43081
        • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
      • Xenia, Ohio, United States, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
      • Zanesville, Ohio, United States, 43701
        • Genesis - Good Samaritan Hospital
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-0001
        • Geisinger Medical Center
      • State College, Pennsylvania, United States, 16801
        • Geisinger Medical Group - Scenery Park
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Cancer Center
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57117-5039
        • Sioux Valley Hospital and University of South Dakota Medical Center
      • Sioux Falls, South Dakota, United States, 57105
        • Medical X-Ray Center, PC
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
        • Hematology-Oncology Associates of Fredericksburg, Incorporated
    • Wisconsin
      • Fond du Lac, Wisconsin, United States, 54935
        • Central Wisconsin Cancer Program at Agnesian HealthCare
      • Green Bay, Wisconsin, United States, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, United States, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Oconto Falls, Wisconsin, United States, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Sturgeon Bay, Wisconsin, United States, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay
    • Wyoming
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center at Sheridan Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low-dose 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.

Experimental: 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.

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.

Experimental: 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.

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 Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in average hot flash score from baseline until week 7 of treatment
Time Frame: Up to 7 weeks
Up to 7 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: Up to 7 weeks
Up to 7 weeks
Mood- and hot flash-related daily interference with activities
Time Frame: Up to 7 weeks
Up to 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 10, 2006

First Submitted That Met QC Criteria

August 10, 2006

First Posted (Estimate)

August 15, 2006

Study Record Updates

Last Update Posted (Estimate)

December 13, 2016

Last Update Submitted That Met QC Criteria

December 9, 2016

Last Verified

December 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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