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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03148782 -
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase
|
N/A | |
| Recruiting |
NCT06038942 -
Formal Versus Informal Mindfulness Among University Students With Self-reported ADHD, Nonsuicidal Self-injury, or Stress
|
N/A | |
| Not yet recruiting |
NCT06456372 -
Digital Health Intervention for Children With ADHD
|
N/A | |
| Completed |
NCT05518435 -
Managing Young People With ADHD in Primary Care Study
|
||
| Active, not recruiting |
NCT04978792 -
Does Cultivating Self-compassion Improve Resilience to Criticism and Improve Mental Health in Adults With ADHD?
|
N/A | |
| Completed |
NCT03216512 -
Effects of Noise Cancelling Headphones on Neurocognitive and Academic Outcomes in ADHD
|
N/A | |
| Completed |
NCT02900144 -
Modified Comprehensive Behavioral Intervention for Tics (M_CBIT)
|
N/A | |
| Completed |
NCT02829528 -
Little Flower Yoga for Kids: Evaluation of a Yoga and Mindfulness Program for Children With Increased Levels of Emotion Dysregulation and Inattention
|
N/A | |
| Not yet recruiting |
NCT02906501 -
Effect of Risperidone on Cognitive Functions in Adolescents With ADHD and Behavioral Disturbances
|
N/A | |
| Completed |
NCT02562469 -
ACTIVATE: A Computerized Training Program for Children With ADHD
|
N/A | |
| Terminated |
NCT02271880 -
Improving Medication Adherence in ADHD Adolescents
|
N/A | |
| Recruiting |
NCT02255565 -
Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study
|
Phase 4 | |
| Completed |
NCT02463396 -
Mindfulness Training in Adults With ADHD
|
N/A | |
| Completed |
NCT01673594 -
Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
|
Phase 4 | |
| Completed |
NCT02300597 -
Internet-based Support for Young People With ADHD and Autism - a Controlled Study
|
N/A | |
| Active, not recruiting |
NCT01137318 -
Combined Cognitive Remediation and Behavioral Intervention for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)
|
Phase 2 | |
| Completed |
NCT01404273 -
Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder
|
N/A | |
| Completed |
NCT00586157 -
Study of Medication Patch to Treat Children Ages 6-12 With ADHD
|
Phase 4 | |
| Completed |
NCT00573859 -
The Reinforcing Mechanisms of Smoking in Adult ADHD
|
Phase 1/Phase 2 | |
| Completed |
NCT00228540 -
Study to Assess Satisfaction With Modafinil Treatment in Children and Adolescents With ADHD
|
Phase 3 |