Park, H.Y., Lee, B.J., Kim, J.H., Bae, J.N., & Hahm, B.J. (2012). Rapid improvement of depression and quality of life with escitalopram treatment in outpatients with breast cancer: A 12-week, open-label prospective trial. Progress in Neuro-Psychopharmacology and Biological Psychiatry, 36, 318–323.

DOI Link

Study Purpose

To investigate the effectiveness and tolerability of open-label treatment with escitalopram in patients with breast cancer who have major depressive disorder

Intervention Characteristics/Basic Study Process

Patients received escitalopram at 5 mg/day in week 1. After week 1, the dose was adjusted to 5–20 mg/day. Patients were evaluated at baseline, 1, 2, 4, 8, and 12 weeks.

Sample Characteristics

  • A total of 79 patients participated in the study. 
  • Patients' mean age was 49.1 years.   
  • The sample was 100% female.
  • All patients had a breast cancer diagnosis.
  • Patients met the criteria for a current major depressive episode and scored 16 or higher on the Hospital Anxiety and Depression Scale.
     

Setting

Outpatient settings in the Republic of Korea
 

Phase of Care and Clinical Applications

Transition phase after initial treatment

Study Design

Prospective study

Measurement Instruments/Methods

  • Hamilton Depression Rating Scale (HAMD) 
  • Functional Assessment of Cancer Therapy Breast (FACT-B)
  • MD Anderson Symptoms Inventory
  • Clinical Global Impression-Severity (CGI-S)
  • Distress Thermometer (DT)
     

Results

62 patients were included in the efficacy analysis, and only 45.6% completed the full 12-week study. Dropouts occurred because of lack of efficacy, no symptom improvement, side effects, and unspecified reasons. 34% of the sample dropped out due to lack of effectiveness or no change in symptoms.

Significant decreases were seen at week 1 and forward in HAMD (p < 0.001), DT (p < 0.001), and CGI-S (p < 0.003). FACT-B scores improved after week 2 (p = 0.011). No differences were observed in baseline scores between responders and nonresponders.

No serious adverse events were reported. The most common side effects were dry mouth, drowsiness, constipation, and increased sweating. Sleep disturbance, shortness of breath, and sadness were improved, but pain, fatigue, and anorexia did not improve.

Conclusions

Escitalopram reduced depression in some patients with breast cancer who had major depressive disorder.

Limitations

  • The sample size was small, fewer than 100 participants.
  • No control group was used, and the study had an open-label design. 
  • The drop-out rate was more than 30% because of lack of effect. 
  • The study was, as the authors said, \"underpowered.\"
     

Nursing Implications

Escitalopram may be an effective treatment for symptoms of depression in some patients with breast cancer; however, about a third of patients in the study did not experience an effect. Nurses should be aware of side effects that may worsen existing symptoms.