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 mild-to-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.

中文翻译：

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舍曲林对多囊卵巢综合征女性抑郁严重程度和催乳素水平的影响：一项安慰剂对照随机试验。

关于抗抑郁药治疗多囊卵巢综合征和抑郁症女性的安全性和有效性的数据很少。在该患者群体中，抗抑郁药物对循环催乳素水平的影响令人担忧。我们旨在评估舍曲林对患有多囊卵巢综合征和轻度至中度抑郁症的女性的抑郁症严重程度和血清催乳素水平的影响。在一项平行设计、双中心、随机对照试验中，我们根据参与者的基线催乳素水平将参与者分为正常 (<25 ng/mL) 和高 (≥25 ng/mL) 催乳素组。每组随机接受每天 50 毫克的舍曲林（每天 25 毫克，持续 1 周后逐渐滴定）或安慰剂。招募医生、结果评估员和研究对象都对治疗不知情。在基线、第三周和第六周通过汉密尔顿抑郁量表评估抑郁严重程度。主要疗效结果是抑郁严重程度的变化。在基线和 6 周后检查催乳素水平，安全性结果是催乳素水平的改变。总共有 513 名女性在两个门诊接受了资格筛查。最终，74 名（38 名正常催乳素和 36 名高催乳素水平）个体被随机分组​​。在 6 周的随访后，无论基线催乳素水平如何，接受舍曲林治疗的患者的抑郁严重程度显着降低（受试者之间的所有 P < 0.001）。此外，在正常 (P = 0.80) 或高催乳素 (P = 0.21) 组中，舍曲林组和安慰剂组之间的催乳素水平没有差异。舍曲林是治疗多囊卵巢综合征女性抑郁症的一种耐受性良好且有效的选择。未来需要更长随访期的研究才能得出更可靠的结论。