Ahmadpanah Mohammad, Pezeshki Rana, Soltanian Ali Reza, Jahangard Leila, Dürsteler Kenneth M, Keshavarzi Amir, Brand Serge
Research Center for Behavioral Disorders and Substances Abuse, Hamadan University of Medical Sciences, Hamadan, Iran.
Modeling of Non-Communicable Diseases Research Center, Department of Biostatistics, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.
J Psychiatr Res. 2022 Feb;146:163-171. doi: 10.1016/j.jpsychires.2021.12.035. Epub 2021 Dec 21.
While the favorable effect of adjuvant clonidine in the treatment of acute mania has been observed already about 40 years ago, this line of treatment has not been further investigated. Here, we resumed this topic, and we tested the effect of adjuvant clonidine, an antihypertensive stimulating the alpha- central adrenergic receptor, on symptoms of mania, cognitive performance, and subjective sleep. To this end, we performed a randomized, double-blind and placebo-controlled clinical trial among inpatients with bipolar disorder I during their acute phase of mania.
A total of 70 inpatients (mean age: 37.40 years; 15.7% females) with diagnosed bipolar disorder I and during their acute manic phase were randomly assigned either to the adjuvant clonidine (0.2 mg/d to a maximum of 0.6 mg/d) or to the placebo condition. Standard medication was lithium at therapeutic dosages. At baseline, participants completed a series of self-rating questionnaires covering sociodemographic information and subjective sleep. Subjective sleep was re-assessed 24 days later at the end of the study. Experts rated participants' acute state of mania with the Young Mania Rating Scale at baseline and at day 12 and day 24. Participants' cognitive performance was assessed at baseline and at day 24 at the end of the study.
Over time, mania scores significantly decreased (large effect size), but more so in the clonidine condition, compared to the placebo condition (medium effect size). Likewise, over time, subjective sleep improved (large effect size), but more so in the clonidine, compared to the placebo condition (medium effect size). Over time, cognitive performance improved (medium effect size), irrespective from the study condition.
Compared to placebo, adjuvant clonidine to lithium improved symptoms of mania, as rated by experts', and subjective sleep quality. Adjuvant clonidine had no further favorable (or detrimental) impact on cognitive performance.
虽然大约40年前就已观察到辅助使用可乐定治疗急性躁狂症有积极效果，但这一治疗方法尚未得到进一步研究。在此，我们重新探讨了这个话题，并测试了辅助使用可乐定（一种刺激中枢α-肾上腺素能受体的抗高血压药物）对躁狂症状、认知表现和主观睡眠的影响。为此，我们在双相I型障碍患者躁狂急性期的住院患者中进行了一项随机、双盲和安慰剂对照的临床试验。
共有70名被诊断为双相I型障碍且处于急性躁狂期的住院患者（平均年龄：37.40岁；女性占15.7%）被随机分配到辅助使用可乐定组（0.2毫克/天，最大剂量为0.6毫克/天）或安慰剂组。标准药物是治疗剂量的锂盐。在基线时，参与者完成了一系列涵盖社会人口统计学信息和主观睡眠的自评问卷。在研究结束时，于24天后重新评估主观睡眠。专家在基线、第12天和第24天使用杨氏躁狂量表对参与者的急性躁狂状态进行评分。在基线和研究结束时的第24天评估参与者的认知表现。
随着时间的推移，躁狂评分显著下降（效应量较大），但与安慰剂组相比，可乐定组下降得更多（效应量中等）。同样，随着时间的推移，主观睡眠得到改善（效应量较大），但与安慰剂组相比，可乐定组改善得更多（效应量中等）。随着时间的推移，认知表现得到改善（效应量中等），与研究组无关。
与安慰剂相比，锂盐辅助使用可乐定可改善专家评定的躁狂症状和主观睡眠质量。辅助使用可乐定对认知表现没有进一步的有利（或有害）影响。
