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 sertraline on somatic and emotional symptoms of depression and on the quality of life of cancer patients

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

• N = 35.
• Mean age = 51.97 (SD = 13.26; 23–72 years).
• 30 female, 5 male.
• Cancer type and stage: diverse. Majority: breast cancer (54%).
• All patients underwent chemotherapy during the study and were diagnosed with mood disorder at baseline.

Single site (outpatient)

Active treatment

Open-label noncomparative prospective pilot study

• Hospital Anxiety and Depression Scale (HADS) for depression and anxiety
• Montgomery-Asberg Depression Rating Scale (MADRS) for depression
• Mini-Mental Adjustment to Cancer (mini-MAC) scale for psychological response to the diagnosis of cancer
• Clinical Global Impression (CGI) for severity of psychological illness
• Dosage Record and Treatment Emergent Symptom (DOTES) scale for the adverse effects of the clinical treatments and their possible relation to the drug used
• Quality of Life (QL) index for quality of life

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, HADS and MADRS, and HADS anxiety scores significantly decreased during the 12 weeks of the study (all p's < 0.05). Mean mini-MAC scores show that hopelessness and anxious preoccupation decreased significantly at T2, compared with scores at T0 (p < 0.05). Quality of life improved over time (p < 0.05). CGI improved over the treatment period; however, no statistical tests were involved. No severe adverse effects were observed. 6 patients reported varying degrees of side effects (e.g., nausea, agitation, insomnia, dizziness).

Sertraline may be effective; a more definitive conclusion requires stronger evidence.

• Small sample: < 100.
• Internal validity is limited because of the lack of a control group, the lack of control over the lapse of time since the beginning of cancer therapy, and the small sample size.
• External validity is limited because the sample size was small and testing occurred in one setting only.
• Minor flaws include lack of information regarding measurements of validity and reliability.

Nurses can tell patients that sertraline may be an option in the treatment of symptoms of depression during chemotherapy.