Single-dose Potassium Supplementation in ADHD Patients With Lidocaine Ineffectiveness
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Prevalence of lidocaine ineffectiveness in those with ADHD
研究概览
简要总结
Randomized, controlled, double-blind trial of the effect of a single dose of potassium on ADHD symptoms as measured by changes in measures of symptoms of ADHD correlated with the results of their Lidocaine Effectiveness Test.
详细描述
Subjects with a confirmed diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), who are either untreated or poorly controlled with existing ADHD therapy, will be recruited for a single, four-hour session.
Each subject will be tested for lidocaine effectiveness using the application of lidocaine gel to the tongue and assessment by taste.
The subjects will then be assigned to two arms, (1) lidocaine sensitive (effective) or (2) lidocaine insensitive (ineffective), and then randomized as to an intervention of potassium supplementation or a placebo.
Each subject will:
- Complete questionnaires about their history of certain symptoms and a food diary.
- Get an ECG to exclude those with arrhythmias.
- Have their baseline serum potassium tested
- Have measures of ADHD symptoms performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The scoring of the lidocaine test is masked, using the coded identity of the tastes. The scoring will be done during the visit by the Scoring and Randomization Specialist so that the patient can be assigned to an intervention or control group to maintain equal numbers in treatment versus control groups. To prevent bias, the Scoring and Randomization Specialist will not be involved in any of the ADHD assessment steps and the patients will not be told about their lidocaine status until after all study testing is done. The subjects and other study personnel such as those doing the ADHD testing will be told not to discuss what they could or couldn't taste. Having scored the lidocaine test, the Scoring and Randomization Specialist will assign subjects to Intervention versus Control using a 1-to-1 allocation.
入排标准
- 年龄范围
- 13 Years 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously documented ADHD diagnosis
- •Untreated or taking existing ADHD drugs, but symptoms poorly controlled (e.g., symptoms not well managed by amphetamines, including ongoing inattention and impulsivity)
排除标准
- •Well treated with existing ADHD medication
- •IQ less than 80
- •Severe head trauma that led to loss of consciousness for more than an hour or required surgery
- •Birth weight below 5 pounds or 2270 grams
- •Severe autism (milder conditions described as Asperger syndrome or "high-functioning autism" are not excluded)
- •Comorbid psychiatric disorders, such as generalized anxiety disorder, major depressive disorder, schizophrenia and schizoaffective disorder, bipolar disorder, and any co-morbid condition at the discretion of the PI that would interfere with a patient's ability to participate
- •Mouth lesions, known to temporarily interfere with lidocaine effectiveness
- •Renal disease or abnormal kidney function or receiving dialysis
- •An individual has a factor likely to reduce penetrance, including excessive salt loss, such as caked salt on the body after exercise and Cystic fibrosis in a relative suggestive of the individual being a carrier.
- •Heart arrhythmia, known or evident on ECG
- •Known intolerance or allergy to lidocaine
- •Already taking supplemental potassium or renin angiotensin aldosterone inhibitors or other potassium elevating agents (see list below)
- •Angiotensin Converting Enzyme Inhibitors
- •Alacepril (not available in US)
- •Benazepril (Lotensin)
- •Captopril (trade name Capoten)
- •Cilazapril (Inhibace)
- •Delapril (not available in US)
- •Enalapril (Vasotec/Renitec)
- •Fosinopril (Fositen/Monopril)
- •Imidapril (Tanatril)
- •Lisinopril (Listril/Lopril/Novatec/Prinivil/Zestril)
- •Moexipril (Univasc)
- •Perindopril (Coversyl/Aceon/Perindo)
- •Quinapril (Accupril)
- •Ramipril (Altace/Prilace/Ramace/Ramiwin/Triatec/Tritace)
- •Spirapril (Renormax)
- •Temocapril (not available in US)
- •Teprotide (but not active by oral administration and not used in US)
- •Trandolapril (Mavik/Odrik/Gopten)
- •Angiotensin receptor blockers
- •Azilsartan (Edarbi)
- •Candesartan (Atacand)
- •Eprosartan (Teveten)
- •Fimasartan (Kanarb)
- •Irbesartan (Avapro)
- •Losartan (Cozaar)
- •Olmesartan (Benicar/Olmetec)
- •Telmisartan (Micardis)
- •Valsartan (Diovan)
- •Aldosterone antagonists
- •Spironolactone (Aldactone)
- •Eplerenone (Inspra)
- •Renin inhibitors
- •a. Aliskiren (Tekturna, Rasilez)
- •Other potassium elevating agents
- •Antibiotics, including penicillin G and trimethoprim
- •Azole antifungals
- •Beta-blockers
- •Herbal supplements, including milkweed, lily of the valley, Siberian ginseng, Hawthorn berries
- 另有 2 项未显示
研究组 & 干预措施
Lidocaine-effective ADHD: Intervention
Single-dose potassium gluconate oral capsule intervention for ADHD subjects for whom lidocaine is effective
干预措施: Potassium Gluconate Oral Capsule (Drug)
Lidocaine-effective ADHD: Placebo
Single-dose placebo oral capsule intervention for ADHD subjects for whom lidocaine is effective
干预措施: Placebo oral capsule (Drug)
Lidocaine-ineffective ADHD: Intervention
Single-dose potassium gluconate oral capsule intervention for ADHD subjects for whom lidocaine is ineffective
干预措施: Potassium Gluconate Oral Capsule (Drug)
Lidocaine-ineffective ADHD: placebo
Single-dose placebo oral capsule intervention for ADHD subjects for whom lidocaine is ineffective
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Prevalence of lidocaine ineffectiveness in those with ADHD
时间窗: Baseline
Investigator assesses identification and intensity of tastes (such as sweet) before and after application of oral lidocaine gel to the tongue.
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(1-2 hours after intervention)
- Other discomforts(1-2 hours after intervention)
- Change in ADHD-RS questionnaires(Baseline and ~1-2 hours later, 1 hour after intervention)
- Change in Clinical Global Impression Physician Completed Questionnaire(Baseline and ~1-2 hours later, 1 hour after intervention)
- Change in scores using Quotient ADHD System(Baseline and ~1 hour after intervention)