Citalopram in Treating Postmenopausal Women With Hot Flashes

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00363909
First received: August 10, 2006
Last updated: July 4, 2015
Last verified: July 2015
  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 Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: Yes ]
  • Mood- and hot flash-related daily interference with activities [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 254
Study Start Date: November 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363909

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

Additional 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, CDR0000489567
Study First Received: August 10, 2006
Last Updated: July 4, 2015
Health Authority: United States: Federal Government

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
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015