Pramipexole to Improve Cognition in Bipolar Disorder: A Randomized Controlled Trial.
Pramipexole to Improve Cognition in Bipolar Disorder: A Randomized Controlled Trial.
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DOI：
10.1097/jcp.0000000000001407
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发表时间：
2021-07-01
影响因子：
2.9
通讯作者：
Burdick KE
中科院分区：
文献类型：
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作者：
Van Meter AR;Perez-Rodriguez MM;Braga RJ;Shanahan M;Hanna L;Malhotra AK;Burdick KE
补充的数字内容可在文本中找到。成人双相情感障碍（BD）经常经历神经认知障碍，对功能和生活质量产生负面影响。先前的试验已经发现，多巴胺激动剂可以改善健康志愿者的认知能力，并且情绪稳定、轻度认知缺陷的成年双相障碍患者也可能受益。我们假设多巴胺激动剂丙哌索可以改善双相障碍患者的神经认知功能。我们招募了60名诊断为双相障碍I或II的成年人（18-65岁）进行为期8周的双盲安慰剂对照试验（NCT02397837）。所有患者在基线时均有稳定的情绪和临床显著的神经认知障碍。参与者随机接受普拉克索（n = 31）或安慰剂（n = 29），剂量开始为0.125 mg，每天2次，并增加到目标4.5 mg/d。在试验结束时，普兰克索组的主要结局指标——matrix Consensus Cognitive Battery综合评分（mean [SD] = 1.15[5.4]）并没有比安慰剂组（mean [SD] = 4.12 [5.2], Cohen’SD = 0.56, P = 0.049）改善更多，混合模型在控制症状的情况下，显示治疗组与matrix Consensus Cognitive Battery评分之间没有关联。无严重不良事件报告。这些结果表明，普拉克索并不是一种有效的双相障碍认知增强剂，即使在先前工作中与有益反应相关的特征丰富的样本中也是如此。在成年双相障碍患者中存在不同的认知亚群，神经生物学上的相关差异可能影响对普拉克索的反应。为了更好地了解双相障碍患者认知缺陷的发病和本质，进一步的研究将是朝着更个性化的治疗方法迈出的重要一步。
Supplemental digital content is available in the text. Adults with bipolar disorder (BD) often experience neurocognitive impairment that negatively impacts functioning and quality of life. Previous trials have found that dopamine agonist agents improve cognition in healthy volunteers and that adults with BD who have stable mood and mild cognitive deficits may also benefit. We hypothesized that pramipexole, a dopamine agonist, would improve neurocognitive function in patients with BD. We recruited 60 adults (aged 18–65 years) with a diagnosis of BD I or II for an 8-week, double-blind, placebo-controlled trial (NCT02397837). All had stable mood and clinically significant neurocognitive impairment at baseline. Participants were randomized to receive pramipexole (n = 31) or a placebo (n = 29), dose was initiated at 0.125 mg 2 times a day and increased to a target of 4.5 mg/d. At trial end, the primary outcome, MATRICS Consensus Cognitive Battery composite score, had not improved more in the pramipexole group (mean [SD] = 1.15 [5.4]) than in the placebo group (mean [SD] = 4.12 [5.2], Cohen’s d = 0.56, P = 0.049), and mixed models, controlling for symptoms, showed no association between treatment group and MATRICS Consensus Cognitive Battery scores. No serious adverse events were reported. These results suggest that pramipexole is not an efficacious cognitive enhancement agent in BD, even in a sample enriched for characteristics that were associated with a beneficial response in prior work. There are distinct cognitive subgroups among adults with BD and may be related differences in neurobiology that affect response to pramipexole. Additional research to better understand the onset and nature of the cognitive deficits in people with BD will be an important step toward a more personalized approach to treatment.