精神分裂症患者辅助使用哌醋甲酯缓释剂:旨在改善功能和认知结果的单中心固定剂量交叉开放标签试验方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
Naista Zhand , David Attwood , Alain Labelle , Ridha Joober , Carrie Robertson , Philip D. Harvey
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引用次数: 0

摘要

背景认知症状是精神分裂症的核心症状之一,与不良的功能预后和疾病负担有关。迄今为止,还没有针对这些症状群的有效药物治疗方法。本研究旨在对稳定服用抗精神病药物的精神分裂症患者在标签外使用哌醋甲酯缓释剂(ER)进行评估,并评估其对患者功能和认知结果的疗效。计划进行一项开放标签固定剂量对照交叉试验。符合条件的参与者将被随机分配到两组研究中的一组:1)接受为期四周的哌醋甲酯 ER 36 毫克附加治疗,或 2)接受为期四周的常规治疗。4周后,参与者将互换治疗组。研究持续时间包括 8 周的治疗和 12 周的随访。主要结果测量包括基于片剂的功能和认知测试(VRFCAT 和 BAC),将在基线和每 4 周进行一次。我们的目标是共招募 24 名参与者。预期成果拟议项目旨在评估精神分裂症认知缺陷的潜在治疗方案,目前的治疗指南尚未对此提出建议。本研究的新颖性和重要意义在于,它调查了这种干预方法,并评估了它在一家三甲医院的 "真实环境 "中的适用性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Adjunctive methylphenidate extended release in patients with schizophrenia: Protocol of a single-centre fixed dose cross-over open-label trial to improve functional and cognitive outcomes

Background

Cognitive symptoms, among the core symptoms of schizophrenia, are associated with poor functional outcome and burden of illness. To date, there is no effective pharmacological treatment for these symptom clusters. Augmentation with psychostimulants has been proposed as a potential treatment option.

Objectives

The present study aims to assess off-label use of adjunctive methylphenidate extended release (ER) in patients with schizophrenia who are stable on antipsychotic medications, and to assess its efficacy on functioning and cognitive outcome.

Methods

This is a single centre study at the Royal Ottawa Mental Health Centre. An open-label fixed dose controlled cross-over trial is planned. Eligible participants will be randomized into one of two arms of the study: 1) four weeks of add-on methylphenidate ER 36 mg, or 2) four weeks of treatment as usual. At 4 weeks, participants will switch arms. The duration of the study includes 8 weeks of treatment and a follow-up visit at 12 weeks. Primary outcome measures include tablet-based tests of functioning and cognition (VRFCAT and BAC) and will be administered at baseline and every 4 weeks. We are aiming to recruit a total of 24 participants.

Expected outcomes

The proposed project intends to assess a potential treatment option for cognitive deficits of schizophrenia, for which there are no recommendations by current treatment guidelines. The novelty and significance of the current study is that it investigates this intervention and assess applicability of it in a “real world setting” in a tertiary care hospital.

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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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