A pilot trial of quetiapine, lithium, or placebo added to divalproex sodium for hypomanic or manic episodes in ambulatory adults with bipolar I disorder.
A pilot trial of quetiapine, lithium, or placebo added to divalproex sodium for hypomanic or manic episodes in ambulatory adults with bipolar I disorder.
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DOI：
10.1186/s40345-022-00252-w
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发表时间：
2022-03-02
影响因子：
4
通讯作者：
Suppes T
中科院分区：
文献类型：
--
作者：
Cosgrove VE;Allende S;Gwizdowski I;Grace Fischer E;Ostacher M;Suppes T
许多 I 型双相情感障碍患者对情绪稳定药物的单一疗法没有反应，住院和门诊通常使用联合治疗方案来进行双相情感障碍的急性和维持治疗。我们研究了对于目前出现躁狂症状的 I 型双相情感障碍受试者的急性治疗，联合疗法是否比单一疗法更有效。主要假设是，与单独治疗相比，联合治疗可以更大程度地减少躁狂和轻躁狂症状。第二个假设是，与单独治疗相比，联合治疗与较低的抑郁水平相关。最后，使用事后探索性目标来检查联合疗法中副作用严重程度对退出风险的影响是否比单独疗法更大。在这项为期 12 周、双盲、安慰剂对照的流动试点试验中，患有 I 型双相情感障碍的参与者 (n = 75) 被随机分配至：(1) 双丙戊酸单药加安慰剂 (DVP + PBO)，(2) 双丙戊酸加盲法锂联合治疗 (DVP + Li) 或 (3) 双丙戊酸加盲法喹硫平 （DVP + QTP）。联合疗法（相对于单一疗法）与躁狂、轻躁狂或抑郁症状的改善无关。联合疗法和单一疗法之间副作用严重程度对研究保留的影响没有差异。然而，DVP + Li 组的退出风险明显高于 DVP + PBO 组。联合疗法和单一疗法之间没有发现躁狂、轻躁狂或抑郁的纵向差异。副作用严重程度对研究保留的影响在各组之间没有差异。由于样本量较小且治疗组之间的损耗率存在差异，因此必须谨慎解释该试点试验的结果。试验注册 ClinicalTrials.gov 标识符：NCT00183443
Many patients with bipolar I disorder do not respond to monotherapy treatment with mood-stabilizing medications, and combination regimens are commonly used in both inpatient and outpatient settings for the acute and maintenance treatment of bipolar disorder. We studied whether combination therapy is more effective than monotherapy for the acute treatment of subjects with bipolar I disorder currently experiencing manic symptoms. The primary hypothesis was that combination treatments would be associated with greater reductions in symptoms of mania and hypomania than monotherapy alone. The secondary hypothesis was that combination therapies would be associated with lower depression levels than monotherapy alone. Last, a post-hoc exploratory aim was used to examine whether the effect of side effect severity on risk-of-dropout would be greater in combination therapies than in monotherapy alone. In this 12-week, double-blind, placebo-controlled ambulatory pilot trial, participants (n = 75) with bipolar I disorder were randomly assigned to: (1) monotherapy divalproex plus placebo (DVP + PBO), (2) combination therapy of divalproex plus blinded lithium (DVP + Li) or (3) divalproex plus blinded quetiapine (DVP + QTP). Combination therapies (vs. monotherapy) were not associated with improved symptoms of mania, hypomania or depression. The effect of side effect severity on study retention did not differ between combination therapies and monotherapy. However, the risk-of-dropout was significantly greater in the DVP + Li arm versus the DVP + PBO arm. No longitudinal differences in mania, hypomania or depression were found between combination therapies and monotherapy. The effect of side effect severity on study retention did not differ between groups. Due to the small sample size and differential rates of attrition between treatment arms, results of this pilot trial must be interpreted with caution. Trial registration ClinicalTrials.gov identifier: NCT00183443
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影响因子：
3.2
作者：
Scott, Jan
通讯作者：
Scott, Jan
影响因子：
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作者：
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影响因子：
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作者：
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通讯作者：
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