Single-dose Potassium Supplementation in Patients With ADHD for Whom the Anesthetic Lidocaine is Ineffective

ADHD Clinical Trial

Official title: Single-dose Potassium Supplementation in ADHD Patients With Lidocaine Ineffectiveness

Status Enrolling by invitation

Clinical Trial Summary

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.

Clinical Trial Description

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.

Then each subject will receive the intervention of a single dose of the potassium or placebo.

After the wait of one hour, a repeat serum potassium and measurement of symptoms will be performed.

Note; The FDA also requires a Columbia Suicide Severity Rating Scale (C-SSRS) for all ADHD trials ;

Related Conditions & MeSH terms

• ADHD

• NCT number: NCT03563573
• Study type: Interventional
• Source: AlkaliDx, Inc.
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: July 1, 2018
• Completion date: December 31, 2018