jRCT2031260065招募中不适用
A Phase II, Investigator-Initiated, Placebo-Controlled, Double-Blind, Randomized, 3-Arm, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of Dextromethorphan for Clozapine-Induced Sialorrhea (DEXCIS )
未提供0 个研究点目标入组 30 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18age old over 至 65age old under（—）
- 性别
- All
入选标准
- •Patients diagnosed with treatment-resistant schizophrenia and currently receiving clozapine treatment.
- •Patients whose clozapine dosage has remained unchanged for at least 28 days prior to obtaining informed consent.
- •Patients presenting with clozapine-induced sialorrhea (CIS) at screening, defined as a Drooling Severity Scale (DSS) score of 3 or higher (Moderate: drool reaches the lips or chin).
- •Patients aged between 18 and 65 years at the time of obtaining informed consent.
- •Patients (or their legally authorized representatives) who have provided written informed consent voluntarily after receiving a full explanation and gaining a thorough understanding of the clinical trial.
排除标准
- •Patients with comorbid diseases of the salivary glands or oral cavity that may affect sialorrhea (e.g., Sjogren's syndrome).
- •Patients with comorbid diseases other than those of the salivary glands or oral cavity that may affect sialorrhea (e.g., Parkinson's disease, dementia with Lewy bodies, amyotrophic lateral sclerosis, sequelae of cerebral infarction, cerebral palsy, sequelae of traumatic brain injury).
- •Patients who have used dextromethorphan (DXM) within 14 days prior to obtaining informed consent.
- •Patients who have used NMDA receptor antagonists within 14 days prior to obtaining informed consent.
- •Patients who have used muscarinic receptor antagonists or alpha 2-receptor agonists within 14 days prior to obtaining informed consent.
- •Patients who have used sigma-1 receptor agonists or antagonists within 14 days prior to obtaining informed consent.
- •Patients who have used serotonergic agents within 14 days prior to obtaining informed consent.
- •Patients who have used NaSSAs, tricyclic antidepressants (TCAs), or tetracyclic antidepressants within 14 days prior to obtaining informed consent.
- •Patients who have received electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within 14 days prior to obtaining informed consent.
- •Patients with a history of substance use disorder within 12 months prior to obtaining informed consent (based on DSM-5-TR criteria).
- •Patients with a history of over-the-counter (OTC) drug overdose (e.g., DXM) within 12 months prior to obtaining informed consent.
- •Patients with a history of hypersensitivity to DXM.
- •Patients with a history of serotonin syndrome.
- •Patients with serious comorbid physical illnesses requiring inpatient treatment, or those judged inappropriate for the study by the investigator or sub-investigator.
- •Patients at risk of suicide based on responses to items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening, or those with a suicide attempt within the past 12 months based on response to item
- •Patients who have received other investigational products within 12 weeks prior to the start of study drug administration.
- •Female patients who are pregnant or breastfeeding. For female patients of childbearing potential, those who do not agree to use contraception from the time of informed consent until the end of the observation period. For male patients, those who (or whose partners) do not agree to use contraception from the time of informed consent until the end of the observation period.
- •Other patients judged inappropriate for the safe conduct of the study by the investigator or sub-investigator.
研究者
相似试验
招募中
1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ATX3042024-514744-91-00Betagenon AB, Betagenon AB40
招募中
1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Adaptive Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CLE-905-AG, a M1/M4 Muscarinic Agonist when administered alone or in conjunction with a Peripheral Muscarinic antagonist, in Healthy ParticipantsSchizophrenia2025-521914-25-00Clexio Biosciences Ltd.110
招募中
1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single and Multiple Doses of GTX-11 in Healthy SubjectsPulmonary fibrosis2023-504426-19-00Gat Therapeutics S.L.52
招募中
不适用
A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes (J3R-MC-YDAG)Obesity
OverweightjRCT20312508011,980
尚未招募
不适用
A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin (J3R-MC-YDAL)Overweight
ObesityjRCT2031250803900