Psychiatric Research Center, Roozbeh Psychiatric Hospital.
Psychosomatic Research Center, Imam Hospital.
Int Clin Psychopharmacol. 2021 Sep 1;36(5):238-243. doi: 10.1097/YIC.0000000000000367.
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.
关于抗抑郁药物治疗多囊卵巢综合征合并抑郁症女性的安全性和疗效的数据很少。抗抑郁药物对循环催乳素水平的影响是该患者人群关注的问题。我们旨在评估舍曲林对多囊卵巢综合征和轻度至中度抑郁症女性抑郁严重程度和血清催乳素水平的影响。在一项平行设计、两中心、随机对照试验中，我们根据基线催乳素水平将参与者分层为正常（<25ng/mL）和高（≥25ng/mL）催乳素组。每个组随机接受 50mg 每日舍曲林（每日 25mg 起始，1 周后增加剂量）或安慰剂。入组医生、结局评估者和研究对象均对治疗方案不知情。抑郁严重程度在基线、第 3 周和第 6 周通过汉密尔顿抑郁量表评估。主要疗效结局为抑郁严重程度的变化。催乳素水平在基线和 6 周后检查，安全性结局为催乳素水平的变化。总体而言，有 513 名女性在两个门诊诊所接受了入组筛选。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 周随访后，无论基线催乳素水平如何，接受舍曲林治疗的患者抑郁严重程度均显著降低（所有组间 P<0.001）。此外，在正常催乳素（P=0.80）或高催乳素（P=0.21）组中，舍曲林组和安慰剂组的催乳素水平无差异。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。需要进行更长随访期的未来研究以得出更有力的结论。
