Amiloride Hydrochloride as an Effective Treatment for ADHD

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by State University of New York - Upstate Medical University
Sponsor:
Collaborator:
Upstate Medical University Foundation
Information provided by (Responsible Party):
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT01733680
First received: November 20, 2012
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

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,inihibit, 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.


Condition Intervention Phase
ADHD
Drug: amiloride
Behavioral: Behavioral
Drug: placebo
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • Improvement in ADHD symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Improvement in ADHD symptoms measured by the AISRS and the CGI scales.


Secondary Outcome Measures:
  • Improvement in executive function and emotional self-regulation. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Measuring improvement in executive function and emotional self-regulation on the Behavior Rating Inventory of Executive Function - Adult Version


Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amiloride

Drug: Subjects will take 5mg qd Amiloride for 2 weeks, 10mg qd Amiloride for 3 weeks, 15 mg qd Amiloride for 3 weeks.

Behavioral: Each week subjects will complete the AISRS, BRIEF-A, and CGI.

Drug: amiloride
Subjects will take either amiloride hydrochloride or placebo for 8 weeks.
Other Name: amiloride
Behavioral: Behavioral
Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement
Other Name: ADHD symptoms, executive function, emotional self-regulation
Placebo Comparator: Placebo
Drug: Subjects will take placebo for 8 weeks Behavioral: Each week subjects will complete questionnaires: AISRS, BRIEF-A, and CGI
Behavioral: Behavioral
Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement
Other Name: ADHD symptoms, executive function, emotional self-regulation
Drug: placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Medication naïve male or female adults ages 18-45 years.
  2. A diagnosis of DSM-IV ADHD combined type based on clinical assessment by the study psychiatrist using the Conners Adult ADHD Diagnostic Interview;
  3. proficiency in English;
  4. A baseline score of 24 or more on the AISRS;
  5. ability to swallow pills;
  6. ability to report reliably, understand the nature of the study and sign an informed consent document as determined by the study psychiatrist

Exclusion Criteria:

We will exclude potential participants who:

  1. have had pharmacologic treatment for ADHD in the past year;
  2. are pregnant or nursing;
  3. are Investigators or their immediate family (spouse, parent, child, grandparent, or grandchild);
  4. have any serious, unstable medical illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease;
  5. have severe allergies or multiple adverse drug reactions;
  6. have a current or past history of seizures;
  7. meet current DSM-IV criteria for anxiety or depression or illicit substance abuse in prior six months (these exclusions are feasible because, although the lifetime comorbidity of ADHD with these disorders is high, we and others have shown that the presence of these disorders at the time of ascertainment for adult ADHD studies is less than 10%);
  8. are judged by the study psychiatrist to be at serious suicidal risk.
  9. have current or past diagnoses of schizophrenia or bipolar disorder;
  10. have a history of hypersensitivity to amiloride or drug class members;
  11. have a history of hyperkalemia, diabetes mellitus, renal disease or anuria;
  12. have renal impairment Cr > 1.5; or
  13. are taking potassium supplements, aldosterone antagonists, tacrolimus or ACE inhibitors.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733680

Contacts
Contact: Prashant Kaul, MD 315-425-4400 x53940 Prashant.kaul@va.gov
Contact: Stephen V Faraone, PhD 315-464-3113 sfaraone@childpsychresearch.org

Locations
United States, New York
SUNY Upstate Medical University Not yet recruiting
Syracuse, New York, United States, 13210
Principal Investigator: Stephen V Faraone, PhD         
Principal Investigator: Prashant Kaul, MD         
Sponsors and Collaborators
State University of New York - Upstate Medical University
Upstate Medical University Foundation
Investigators
Principal Investigator: Stephen V Faraone, PhD SUNY Upstate Medical Unversity
Principal Investigator: Prashant Kaul, MD VA Medical Center at Syracuse
  More Information

No publications provided

Responsible Party: State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT01733680     History of Changes
Other Study ID Numbers: 320969
Study First Received: November 20, 2012
Last Updated: November 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
ADHD
executive function
emotional self-regulation

Additional relevant MeSH terms:
Amiloride
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Diuretics
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014