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Citalopram in Treating Postmenopausal Women With Hot Flashes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00363909
First Posted: August 15, 2006
Last Update Posted: December 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
  Purpose

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.


Condition Intervention Phase
Breast Cancer Hot Flashes Psychosocial Effects of Cancer and Its Treatment Drug: citalopram hydrobromide Other: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Phase III Randomized, Double-Blind, Placebo-Controlled Evaluation of Citalopram for the Treatment of Hot Flashes

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Difference in average hot flash score from baseline until week 7 of treatment [ Time Frame: Up to 7 weeks ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: Up to 7 weeks ]
  • Mood- and hot flash-related daily interference with activities [ Time Frame: Up to 7 weeks ]

Enrollment: 254
Study Start Date: November 2006
Study Completion Date: December 2010
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: citalopram hydrobromide
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.

Drug: citalopram hydrobromide
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.

Drug: citalopram hydrobromide
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.

Other: placebo

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363909


  Show 198 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Debra Barton, RN, PhD, AOCN, FAAN Mayo Clinic
  More Information

Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00363909     History of Changes
Other Study ID Numbers: NCCTG-N05C9
NCI-2012-02699 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000489567 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: August 10, 2006
First Posted: August 15, 2006
Last Update Posted: December 13, 2016
Last Verified: December 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
psychosocial effects of cancer and its treatment
hot flashes
breast cancer

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents