EUCTR2019-002778-30-IT进行中（未招募）1 期
Efficacy and safety of memantine as antimanic and mood-stabilizing medication for adolescents with Bipolar Disorder: a multi-center, randomized, double-blind, placebo-controlled clinical trial - Memantine BD
IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA0 个研究点目标入组 68 人开始时间: 2021年1月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) either sex, aged 13-17 years at baseline;
- •2) DSM-5 diagnosis of BD (Type I, Type II, Cyclothymic Disorder, Unspecified) with mild to moderate symptom-severity, with current manic, mixed, or hypomanic symptoms (not psychotic) based on expert clinical assessment confirmed with structured diagnostic assessment (with Kiddie-Schedule for Affective Disorders and Schizophrenia for School-aged Children, Present and Lifetime version [K-SADS-PL]);
- •3) YMRS total score of 20-40 at baseline;
- •4) CGI-BP severity score of 4-6 at baseline;
- •5) providing assent to participate and signed consent by a parent or legal representative;
- •6) girls deemed to be of reproductive potential, must have a confirmed negative urine pregnancy test at intake, and use adequate contraception throughout the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) YMRS item 8 (delusions; hallucinations) score = 8;
- •2) exposure to any medicine that can interfere with assessments of safety, tolerability, or efficacy of memantine or placebo, or with the conduct/interpretation of the study; specifically: antipsychotic-antimanic agents including haloperidol, risperidone, quetiapine, aripiprazole, olanzapine, ziprasidone, carbamazepine, lamotrigine, valproate, and antidepressants; ketamine or other NMDA antagonists in last the month prior to enrolment;
- •3) significant current risk of suicide (in the opinion of the Investigator or a yes response to suicidal ideation questions 4 or 5 on the Columbia-Suicide Severity Rating Scale [C-SSRS]) within the last 6 months;
- •4) intellectual disability (IQ <70), organic mental disorder, or mental disorder due to a general medical condition or substance abuse (DSM-5 criteria);
- •5) comorbid DSM-5 diagnosis of Substance Abuse Disorder;
- •6) a serious or unstable general medical illness or clinically significant abnormal vital signs or ECG abnormality;
- •7) known hypersensitivity to the active substance or to any of the excipients;
- •8) patient with severe renal impairment (glomerular filtration rate, GFR, < 89 mL/min. GRF 89–60 mL/min: damage with minimal loss of renal function), accoding to Schwartz Equation;
- •9) patient with severe hepatic impairment: at least one of the following parameters >= 2 ULM (referred to the range of normality of this age group and judged clinically significant by the investigators/ specialist medical consultant and/or needing medical treatment: alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP) and gamma glutamyl transferase (GGT), bilirubin);
- •10) patient with serious forms of cardiovascular disease (severe and moderate congenital heart disease: severe and moderate ventricular septal defect, severe and moderate atrial septal defect, Tetralogy of Fallot, complete Transposition of the Great Arteries; severe and moderate valvular stenosis and prolapses; cardiac hypertrophy,), arrhythmias (atrial fibrillation, Paroxysmal supraventricular tachycardia (PSVT), atrial flutter, Wolf-Parkinson-White (WPW), ventricular fibrillation, ventricular tachycardia, Brugada syndrome, severe Sinus bradycardia FC<40 bp/m).
研究者
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