Effect of sertraline on depression severity and prolactin levels in women with polycystic ovary syndrome: a placebo-controlled randomized trial

Abstract

There is a paucity of data regarding the safety and efficacy of antidepressant therapy in women with polycystic ovary syndrome and depression. The effect of antidepressant medications on circulating prolactin levels is of concern in this patient population. We aimed to evaluate the effect of sertraline on depression severity and serum prolactin levels in women with polycystic ovary syndrome and mildto-moderate depression. In a parallel-design, two-center, randomized controlled trial, we stratified participants according to their baseline prolactin level into normal (<25 ng/mL) and high (≥25 ng/mL) prolactin groups. Each group was randomized to receive 50 mg daily sertraline (up-titrated after 25 mg daily for 1 week) or placebo. The enrolling physicians, outcome assessors, and study subjects were all blind to the treatment. Depression severity was assessed by the Hamilton depression rating scale at baseline, the third, and the sixth weeks. The primary efficacy outcome was a change in depression severity. Prolactin levels were checked at baseline and after 6 weeks, and the safety outcome was the alteration in prolactin levels. Overall, 513 women were screened for eligibility in two outpatient clinics. Ultimately, 74 (38 normal prolactin and 36 high prolactin level) individuals were randomized. After 6 weeks of follow-up, depression severity was significantly reduced among patients who received sertraline regardless of the baseline prolactin levels (all between subjects P < 0.001). Furthermore, there was no difference in prolactin levels between the sertraline and placebo arms in normal (P = 0.80) or high prolactin (P = 0.21) groups. Sertraline is a well-tolerated and effective choice for treating depression in women with polycystic ovary syndrome. Future studies with longer follow-up periods are required to draw more robust conclusions.

Considerations in the Treatment of Depression and Anxiety in Women with PCOS

“…The authors noted that both in the normal and high baseline prolactin groups, those who received sertraline had significantly lower HDRS scores after treatment compared to placebo ( p < 0.001); however, sample sizes were small and mean scores were not reported. 54 The guidelines recommended considering antidepressants if psychotherapeutic strategies are unsuccessful or symptoms are persistent. When looking in the general population, the 2019 American Psychological Association guidelines recommend clinicians offer either psychotherapy or second-generation antidepressants such as selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors for the initial treatment of depression in adults.…”

Celecoxib in Treatment of Postpartum Depression: A Case Report

“…This scale has been applied in many clinical trials to explore severity of depression. 9 , 10 According to the HDRS, she had a score of 16.…”

The effects of behavioral intervention on anthropometric, clinical, and biochemical parameters in patients with polycystic ovary syndrome: a systematic review and meta-analysis

“…The exact cause and pathogenesis of PCOS are still not yet fully understood, and there is currently no definitive cure for the condition ( 5 ). PCOS can significantly impact patients’ quality of life and lead to psychological issues such as low self-esteem and depression ( 6 ). PCOS patients often experience a range of symptoms, including menstrual and ovulation disorders, infertility, metabolic syndrome, emotional distress, and reproductive problems.…”