Lydiatt, W.M., Bessette, D., Schmid, K.K., Sayles, H., & Burke, W.J. (2013). Prevention of depression with escitalopram in patients undergoing treatment for head and neck cancer: Randomized, double-blind, placebo-controlled clinical trial. JAMA OtolaryngologyHead & Neck Surgery, 139, 678-686.

DOI Link

Study Purpose

To determine whether prophylactic use of the antidepressant escitalopram oxalate would decrease the incidence of depression in patients receiving primary therapy for head and neck cancer

Intervention Characteristics/Basic Study Process

Patients were randomized and stratified by sex, site, stage (early vs. advanced), and the primary means of treatment (radiation or surgery). During the study, patients received either escitalopram or placebo. This was dosed at one tablet (10 mg if escitalopram) and increased by one tablet during the second week. This was the study dose until week 16. At this point, all patients were “weaned” by 10 mg per week, then “medication” was discontinued. Patients were reassessed at 20, 24, and 28 weeks.

Sample Characteristics

  • N = 125 
  • MEAN AGE: 63.5 years
  • MALES: 118 (79.7%), FEMALES: 30 (20.3%)
  • KEY DISEASE CHARACTERISTICS: Newly diagnosed head and neck cancer (newly diagnosed or recurrent stage II–IV epidermoid cancer of head and neck)
  • OTHER KEY SAMPLE CHARACTERISTICS: Patient must be willing to participate and must be non-depressed (excluded if cognitively impaired, had advanced cancer or limited life expectancy of less than six months, met diagnostic criteria for mental illness, or undergoing treatment for depression or anxiety).

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Outpatient   
  • LOCATION: Nebraska Methodist Cancer Center, University of Nebraska Medical Center

Phase of Care and Clinical Applications

PHASE OF CARE:  Active antitumor treatment

APPLICATIONS: Elder care, palliative care

Study Design

Randomized, double-blind, placebo-controlled

Measurement Instruments/Methods

  • Quick Inventory of Depressive Symptomology-Self Rated (QIDS-SR)
  • Mini-International Neuropsychiatric Interview (MINI)
  • Quick Inventory of Depressive Symptomology-Clinician (QIDS-C)

Results

Prophylactic escitalopram reduced the rate of depression in patients with head and neck cancer undergoing treatment. Rate of depression was 10% with escitalopram and 24.6% among those on placebo (p = .04). The rate of depression was significantly higher in patients receiving radiation as their primary therapy as compared to  surgery. Those patients who received drug reported better overall and health-related quality of life throughout the trial and during three consecutive months following drug cessation. Due to unacceptable side effects of medication, 12.8% withdrew from the study.

Conclusions

Escitalopram used in the setting of head and neck cancer immediately following diagnosis can have a positive effect on depression, possibly preventing depression from occurring. It also positively affects quality of life and ability to cope with cancer treatments, possibly enabling patients to continue with treatments.

Limitations

Subject withdrawals ≥ 10%

Nursing Implications

Nurses do not have influence as to what the practitioner prescribes for patients (i.e., escitalopram). However, they can suggest it to practitioners. Some oncology practitioners are reluctant to prescribe anti-depressants, as they feel that this is outside their scope of practice. However, consideration is also generally recommended in professional guidelines. Depression may be underdiagnosed in patients with cancer; nurses can advocate for patients by raising attention to the problem in clinical practice. Initial and ongoing assessments for this patient population is imperative based on the high risk for depression. Results should be reported to the provider so patients who are exhibiting signs of depression can be addressed.