NCT00536172

Brief Summary

This study will evaluate the effectiveness of escitalopram to prevent depression in head and neck cancer patients receiving treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4 depression

Timeline
Completed

Started Dec 2007

Typical duration for phase_4 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 14, 2014

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

4.5 years

First QC Date

September 25, 2007

Results QC Date

December 20, 2013

Last Update Submit

September 8, 2023

Conditions

Depression

Keywords

AntidepressantMajor depressionPreventionHead and neck cancer

Outcome Measures

Primary Outcomes (1)

  • Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16)

    Number of participants reaching pre-defined threshold on the QIDS-SR-16 of \>/=11. The QIDS-SR-16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores \>/= 11 correspond to moderate to severe depression.

    Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28

Study Arms (2)

Escitalopram

EXPERIMENTAL

Participants will receive treatment with escitalopram

Drug: Escitalopram

Placebo

PLACEBO COMPARATOR

Participants will receive treatment with placebo

Drug: Placebo

Interventions

EscitalopramDRUG

Participants take 10 mg for 1 week and then 20 mg for 15 weeks.

Also known as: Lexapro
Escitalopram
PlaceboDRUG

Placebo distribution matches the active medication.

Also known as: Sugar pill, Inactive substance
Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed or recurrent epidermoid cancer of the head and neck
  • Requires more than minimal therapy for treatment
  • Able to read and write in English
  • Willing to use an effective form of birth control throughout the study

You may not qualify if:

  • Meets MINI criteria for major depression, schizophrenia, or bipolar illness or scores 24 or less
  • Suicidal or psychotic
  • Current allergy or hypersensitivity to citalopram or other SSRIs
  • Treated with monoamine oxidase inhibitors 14 days prior to study entry
  • Use of antidepressants within 1 week of study entry
  • Pregnant or breastfeeding
  • History of an adequate cancer operation, radiation, or chemotherapy within 6 months of study entry
  • Diagnosed with melanoma or lymphoma cancer of the head and neck
  • Currently participating in another research study involving a therapeutic intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (2)

  • Lydiatt WM, Bessette D, Schmid KK, Sayles H, Burke WJ. Prevention of depression with escitalopram in patients undergoing treatment for head and neck cancer: randomized, double-blind, placebo-controlled clinical trial. JAMA Otolaryngol Head Neck Surg. 2013 Jul;139(7):678-86. doi: 10.1001/jamaoto.2013.3371.

    PMID: 23788218RESULT

  • Vita G, Compri B, Matcham F, Barbui C, Ostuzzi G. Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD011006. doi: 10.1002/14651858.CD011006.pub4.

    PMID: 36999619DERIVED

MeSH Terms

Conditions

DepressionDepressive Disorder, MajorHead and Neck Neoplasms

Interventions

EscitalopramSugars

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental DisordersNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCarbohydrates

Results Point of Contact

Title
William Burke MD
Organization
University of Nebraska
wjburke@Unmc.edu
4025526005

Study Officials

  • William J Burke, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2007

First Posted

September 27, 2007

Study Start

December 1, 2007

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 21, 2023

Results First Posted

February 14, 2014

Record last verified: 2023-09

Locations

US(1)