Does celecoxib with sodium valproate have an augmentation effect on acute mania in bipolar disorder? A double-blind controlled clinical trial in Iran.

IF 2.1 3区 医学 Q3 PHARMACOLOGY & PHARMACY International Clinical Psychopharmacology Pub Date : 2023-09-01 Epub Date: 2023-04-12 DOI:10.1097/YIC.0000000000000454
Farhad Faridhosseini, Ali Talaei, Najmeh Shahini, Zanireh Salimi, Mahboubeh Eslamzadeh, Samira Ahrari, Meysam Pourgholami, Majid Khadem-Rezaiyan
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Abstract

Inflammatory processes in the brain play a role in acute mania etiopathogenesis. There is little evidence indicating the efficacy of celecoxib adjuvant therapy in treatmenting of manic episodes of bipolar disorder. Therefore, this clinical trial aimed to assess the celecoxib effect on treating acute mania. In a double-blind, placebo-controlled trial, 58 patients meeting the criteria for acute mania were enrolled. After considering eligibility, 45 patients were included in the study and randomly divided into two groups. The first group (23 patients) received sodium valproate 400 mg/day along with celecoxib 400 mg/day, and the second group (22 patients) received sodium valproate 400 mg/day and a placebo. The subjects were evaluated by the Young Mania Rating Scale (YMRS) at the beginning of the study and 9, 18, and 28 days following the initiation of the medication. Evaluation of baseline factors indicated a significant difference in age ( P  = 0.01) and psychiatric history ( P  = 0.02) between the two groups. However, other factors were similar between groups ( P  ≥ 0.05). Comparing the YMRS score between celecoxib and placebo groups revealed no significant difference on days 0, 9, 18, and 28. However, the YMRS score at the end of the study decreased by 16.05 ± 7.65 in the intervention group ( P  < 0.001) and 12.50 ± 5.98 in controls ( P  < 0.001) compared to the baseline, the trend of change was not significant between the two groups during the time of the study ( F  = 0.38; P  = 0.84). Although celecoxib adjuvant therapy indicated no considerable side effects, a longer treatment duration may be needed to detect its beneficial effects for treating acute mania in bipolar patients. Trial registration: Iran clinical trial register: IRCT20200306046708N1.

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塞来昔布联合丙戊酸钠对双相情感障碍急性躁狂症有增强作用吗?伊朗的一项双盲对照临床试验。
大脑中的炎症过程在急性躁狂症的发病机制中扮演着重要角色。目前几乎没有证据表明塞来昔布辅助治疗双相情感障碍躁狂发作的疗效。因此,这项临床试验旨在评估塞来昔布治疗急性躁狂症的效果。在一项双盲、安慰剂对照试验中,58名患者符合急性躁狂症的标准。经过资格审查,45名患者被纳入研究,并随机分为两组。第一组(23 名患者)每天服用 400 毫克丙戊酸钠和 400 毫克塞来昔布,第二组(22 名患者)每天服用 400 毫克丙戊酸钠和安慰剂。受试者在研究开始时以及用药后的 9 天、18 天和 28 天接受了青年躁狂评分量表(YMRS)评估。对基线因素的评估表明,两组受试者在年龄(P = 0.01)和精神病史(P = 0.02)方面存在显著差异。然而,两组之间的其他因素相似(P ≥ 0.05)。比较塞来昔布组和安慰剂组的YMRS评分,发现在第0、9、18和28天没有显著差异。然而,在研究结束时,干预组的 YMRS 评分下降了 16.05 ± 7.65(P≥0.05)。
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来源期刊
CiteScore
4.40
自引率
23.10%
发文量
97
审稿时长
>12 weeks
期刊介绍: International Clinical Psychopharmacology provides an essential link between research and clinical practice throughout psychopharmacology. It reports on studies in human subjects, both healthy volunteers and patients, which relate the effects of drugs on psychological processes. A major objective of the journal is to publish fully refereed papers which throw light on the ways in which the study of psychotropic drugs can increase our understanding of psychopharmacology. To this end the journal publishes results of early Phase I and II studies, as well as those of controlled clinical trials of psychotropic drugs in Phase II and IV. Other topics covered include the epidemiology of psychotropic drug prescribing and drug taking, the sociology of psychotropic drugs including compliance, and research into the safety and adverse effects of these compounds.
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