Efficacy and target engagement of dopamine agonist pramipexole for anhedonic depression: a randomized placebo-controlled trial.

We evaluated the efficacy and safety of the dopamine agonist pramipexole in patients with mood disorders characterized by clinically significant anhedonia.

我们评估了多巴胺激动剂普拉克索在以临床上显著的快感缺失为特征的心境障碍患者中的疗效和安全性。

In this single-center, randomized, double-blind, placebo-controlledtrial, adults with major depressive disorder, dysthymia or bipolar depression and elevated Snaith-Hamilton Pleasure Scale (SHAPS) scores were assigned (1:1) to flexible dose, once-daily oral pramipexole as add-on treatment or placebo for 9 weeks.

在这项单中心、随机、双盲、安慰剂对照试验中，患有重性抑郁障碍、心境恶劣或双相抑郁且Snaith-Hamilton愉悦量表（SHAPS）评分升高的成年人被按1:1的比例分配至灵活剂量的每日一次口服普拉克索作为附加治疗或安慰剂，为期9周。

The primary outcome was change in SHAPS score from baseline to week 9.

主要结果是基线至第9周SHAPS评分的变化。

Analyses were conducted in the modified intention-to-treatpopulation.

分析是在修改后的意向治疗人群中进行的。

Eighty-five participants were randomized, and 82 were included in the analysis.

共有85名参与者被随机分配，其中82名被纳入分析。

The primary outcome was met: pramipexole was associated with a greater reduction in SHAPS scores compared to placebo (mean difference: -4.04, 95% confidence interval: -6.89 to -1.18, P = 0.006, Hedges' g = 0.62).

主要结果已经实现：普拉克索与安慰剂相比，与更大的SHAPS评分降低相关（平均差异：-4.04，95%置信区间：-6.89至-1.18，P=0.006，Hedges' g=0.62）。

Exploratory analyses indicated that pramipexole was associated with increased light physical activity and relative preservation of reward-related ventral striatal activation.

探索性分析表明，普拉克索与增加的轻度体力活动和相对保留的奖励相关性腹侧纹状体激活相关。

Improvements in anhedonia were sustained during a 6-month open-label extension.

在为期六个月的开放标签扩展研究期间，快感缺失的改善得到了维持。

Pramipexole was generally well tolerated compared to placebo.

与安慰剂相比，普拉克索的耐受性普遍较好。

Pramipexole significantly improved anhedonia and showed a favorable safety profile, supporting its potential as an augmentation strategy in mood disorders.

普拉克索显著改善了快感缺失，并显示出良好的安全性，支持其作为情绪障碍增强策略的潜力。

ClinicalTrials.gov identifiers: NCT05355337 and NCT05825235 .

ClinicalTrials.gov注册号：NCT05355337 和 NCT05825235。