Lack of Efficacy of JNJ-18038683 on Cognitive Impairment in Patients With Stable Bipolar Disorder.

IF 2.9 3区医学 Q2 PHARMACOLOGY & PHARMACY

Journal of Clinical Psychopharmacology Pub Date : 2024-09-01 DOI:10.1097/JCP.0000000000001889

Mahdi Arshadi, Ahmed Z Elmaadawi, Suhayl Nasr, Karu Jayathilake, Stefanie Rassnick, Lisa Ford, Wayne C Drevets, Herbert Y Meltzer

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引用次数: 0

Abstract

Background: The serotonin type 7 (5-HT7) receptor is one of 14 5-HT receptors. It has received attention for its possible role in mood disorders and cognition. The 5-HT7 receptor antagonist, JNJ-18038683, has been reported to be effective in rodent models of depression and REM sleep. Also, 5-HT7 receptor blockade has been postulated to be a key component of cognitive enhancement in a number of drugs. Bipolar disorder (BD) usually endures cognitive impairment (CI); however, no treatment for CI in BD has been approved. This study aimed to evaluate the efficacy of JNJ-18038683 to improve the CI of BD compared to a placebo.

Methods: We conducted a placebo-controlled, 8-week trial of JNJ-18038683 in BD patients. Each patient's data were analyzed and reassessed blindly with a comprehensive neuropsychological battery, depression and hypomania ratings, and overall social and work function measures.

Results: Of 60 patients, 38 (63%) were female, 43 (72%) had BD type 1, and most patients were Caucasian and married. The overall time effect for the combined group shows statistically significant improvement from baseline to week 8 for most of the neurocognitive battery measures. This indicates a significant improvement in psychopathology and cognition during the study time in both JNJ-18038683 and placebo groups, but no difference between groups.

Conclusions: This study showed no efficacy for the improvement of CIBD or mood symptoms with JNJ-18038683 compared to the placebo.

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JNJ-18038683 对稳定型双相情感障碍患者的认知障碍缺乏疗效

背景：血清素 7 型（5-HT7）受体是 14 种 5-HT 受体之一。它因可能在情绪障碍和认知中发挥作用而受到关注。据报道，5-HT7 受体拮抗剂 JNJ-18038683 对抑郁症和快速动眼睡眠的啮齿动物模型有效。此外，5-HT7 受体阻断也被认为是一些药物增强认知能力的关键成分。躁郁症（BD）通常会出现认知障碍（CI），但目前还没有治疗躁郁症认知障碍的药物获得批准。本研究旨在评估 JNJ-18038683 与安慰剂相比对改善 BD 认知障碍的疗效：我们在 BD 患者中进行了为期 8 周的 JNJ-18038683 安慰剂对照试验。我们对每位患者的数据进行了分析，并通过综合神经心理测试、抑郁和躁狂评分以及整体社会和工作功能测试对其进行了盲法重新评估：在 60 名患者中，38 名（63%）为女性，43 名（72%）为 1 型 BD，大多数患者为白种人且已婚。综合组的总体时间效应显示，从基线到第 8 周，大多数神经认知电池测量指标都有统计学意义上的显著改善。这表明在研究期间，JNJ-18038683 组和安慰剂组的精神病理学和认知能力均有明显改善，但组间无差异：本研究表明，与安慰剂相比，JNJ-18038683 对改善 CIBD 或情绪症状没有疗效。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Clinical Psychopharmacology 医学-精神病学

CiteScore

4.00

自引率

3.40%

发文量

231

审稿时长

4-8 weeks

期刊介绍： Journal of Clinical Psychopharmacology, a leading publication in psychopharmacology, offers a wide range of articles reporting on clinical trials and studies, side effects, drug interactions, overdose management, pharmacogenetics, pharmacokinetics, and psychiatric effects of non-psychiatric drugs. The journal keeps clinician-scientists and trainees up-to-date on the latest clinical developments in psychopharmacologic agents, presenting the extensive coverage needed to keep up with every development in this fast-growing field.