ADHD Clinical Trial
Official title:
Amiloride Hydrochloride as an Effective Treatment for ADHD
The investigators are proposing to test a medication derived from our prior studies of the gene SLC9A9. This one gene makes NHE proteins that control how we learn and remember items, which is impaired in ADHD and may cause an inability to plan, prioritize, self-monitor,inhibit, initiate, self-correct, or control one's behavior. The investigators now propose to investigate the therapeutic utility of an NHE inhibitor, amiloride hydrochloride, for the treatment of attention deficit hyperactivity disorder (ADHD) in medication-naïve adults with ADHD.
Our specific aims and hypotheses are as follows:
Primary Aim: Assess the efficacy and adverse effects of amiloride in medication naive ADHD
adults in a placebo controlled study. Hypothesis 1: Amiloride will reduce scores on our
primary outcome measure, the Adult Attention-Deficit/Hyperactivity Disorder Investigator
Symptom Rating Scale (AISRS) and on our secondary outcome, the ADHD specific Clinical Global
Impressions (CGI) improvement scale. Hypothesis 2: Amiloride will be well tolerated and will
have few side effects in adults with ADHD.
Exploratory Aim 2: Assess effects of amiloride on ADHD-associated clinical features. We will
also assess, in an exploratory manner, the effect of amiloride on two clinical features that
are not well treated by current ADHD medications: deficits in emotional self-regulation
(DESR) and executive function deficit (EFD). Hypothesis 3 predicts that amiloride treatment
will reduce symptoms of DESR and of EFD.
We will recruit 40 adults who are diagnosed with ADHD in a double blind placebo controlled
study. 20 subjects will receive amiloride hydrochloride and 20 subjects will receive placebo
for 8 weeks. Participation in the study requires subjects to meet with the physician for a
screening visit, baseline visit and 8 additional weekly visits.
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