Torta, R., Siri, I., & Caldera, P. (2008). Sertraline effectiveness and safety in depressed oncological patients. Supportive Care in Cancer, 16, 83–91.

To examine the effectiveness and safety of the antidepressant sertraline (selective serotonin reuptake inhibitor) in treating somatic and emotional symptoms of depression in patients with cancer

To evaluate the effect of sertraline treatment on quality of life (QOL)

The intervention was a 12-week trial with a flexible dose regimen of sertraline. Patients started at a dosage of 25 mg/day, with a possible increase to 100 mg/day. The treatment response was assessed at baseline (T0), week 4 (T1), and week 12 (T2).

• The study reported on a sample of 35 patients with cancer.
• Mean patient age was 51.97 years, with a range of 23–72 years (SD = 13.26).
• The sample was 86% female and 14% male.
• Cancer type was diverse, but the majority (54%) had breast cancer. Cancer stage was diverse, with relatively even distribution.
• All patients were undergoing chemotherapy during the study, and all were diagnosed with mood disorder at baseline.

• Single site
• Outpatient setting

Patients were undergoing the active treatment phase of care.

An open-label, noncomparative, prospective pilot study design was used.

• Hospital Anxiety and Depression Scale (HADS): To measure depression and anxiety
• Montgomery-Åsberg Depression Rating Scale (MADRS): To measure depression
• Mini-Mental Adjustment to Cancer (Mini-MAC) Scale: To measure psychological response to the diagnosis of cancer
• Clinical Global Impression (CGI): To measure severity of psychological illness
• Dosage Record and Treatment Emergent Symptom (DOTES) Scale: To measure adverse effects of the clinical treatments and their possible relation with the drug used
• Quality of Life Index: To measure QOL

Mean daily dose of sertraline was 57.50 (+_18.74) mg at T1 and 57.41 (+_18.10) mg at T2. Both mean depression scores, analyzed by HADS and MADRS scales, and HADS anxiety scores significantly decreased during the 12 weeks of study (all p values < 0.05). Mean Mini-MAC scores showed that hopelessness and anxious preoccupation decreased significantly at T2 compared with T0 (p < 0.05). QOL improved over time (p < 0.05). CGI was improved over the treatment period; however, no statistical tests were involved. No severe adverse effects were observed. Six patients reported varying degrees of side effects (nausea, agitation, insomnia, and dizziness).

Sertraline may be effective for the treatment of depressed outpatients with cancer. However, stronger evidence is needed.

• The study had a small sample, with less than 100 patients.
• Internal validity is limited due to the lack of control group, the lack of control over the time lapse since cancer therapy, and the small sample size.
• External validity is limited due to the nature of the sample (i.e., small size and single setting).
• Lack of information regarding measurements for validity and reliability is a minor flaw.

Nurses can inform patients of a possible option to decrease depressive symptoms during chemotherapy.