Sertraline shows potential in improving anxiety in primary care setting

Sertraline treatment for 6 weeks can provide improvements in anxiety, quality of life (QoL), and self-rated mental health, but not in depressive symptoms, according to results of a recent study conducted in a primary care setting.

Primary outcome analysis showed no evidence that treatment with sertraline could provide a significant reduction in depressive symptoms at 6 weeks (mean 6-week Patient Health Questionnaire, 9-item version [PHQ-9] score=7.98 vs 8.76; adjusted proportional difference, 0.95; 95 percent [CI], 0.85 to 1.07; p=0.41) vs placebo. [Lancet Psychiatry 2019;pii:S2215-0366(19)30366-9]

Nevertheless, analysis of secondary outcomes revealed that sertraline treatment led to a reduction in anxiety symptoms (Generalized Anxiety Disorder Assessment 7-item version) (adjusted proportional difference, 0.79; 95 percent CI, 0.70 to 0.89), and improvements in mental (but not physical) health-related QoL (12-item Short-Form Health Survey) (adjusted proportional difference, 2.41; 95 percent CI, 1.14 to 3.96; p=0.00021) and self-reported mental health (adjusted odds ratio, 1.96; 95 percent CI, 1.45 to 2.63; p<0.0001).   

Three serious adverse events occurred, with two in the sertraline group and one in the placebo group. One serious adverse event in the sertraline group was likely to be related to study medicine.

This pragmatic, multicentre, double-blind, placebo-controlled randomized trial included 655 patients aged 18 to 74 years who had depressive symptoms of any severity or duration in the past 2 years, where there was clinical uncertainty about the benefit of an antidepressant. Patients (mean age, 39.7 years; female, 59 percent; employed, 66 percent) were randomized (1:1) to receive one capsule of sertraline 50 mg or placebo orally for 1 week, followed by two capsules daily for up to 11 weeks.

At baseline, 54 percent of study participants met the International Classification of Disease and Related Problems 10 (ICD-10) diagnostic criteria for depression, with the rest meeting the generalized anxiety disorder (GAD) criteria. Thirty percent of patients met the criteria for both depression and GAD, and 15 percent met the criteria for mixed anxiety and depressive disorder. The mean PHQ-9 score was 12.0, with 62 percent of patients exceeding a score of 10 (ie, the recommended threshold for clinical use of antidepressants). Nearly two-thirds (60 percent) of patients had previous history of antidepressant use, with the majority (80 percent) reporting a history of previous depression.

Depression, a leading cause of disability globally, is often managed in the primary care setting with selective serotonin reuptake inhibitors (SSRIs) as first-line treatment. Mild depressive symptoms can still cause distress and impairment, and it is common for primary care physicians to prescribe antidepressants even when diagnostic criteria for depression or GAD are not met. [https://www.who.int/news-room/fact-sheets/detail/depression; Lancet Psychiatry 2019;pii:S2215-0366(19)30366-9]

“Our findings support the prescription of SSRI antidepressants in a wider group of participants than previously thought, including those with mild to moderate symptoms who do not meet diagnostic criteria for depression or GAD,” concluded the researchers.