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Amiloride Hydrochloride as an Effective Treatment for ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01733680
Recruitment Status : Terminated (Study stopped due to lack of recruitment)
First Posted : November 27, 2012
Results First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Information provided by (Responsible Party):
State University of New York - Upstate Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
ADHD Drug: amiloride Behavioral: Behavioral Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Amiloride Hydrochloride as an Effective Treatment for ADHD
Study Start Date : September 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

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

Primary Outcome Measures :
  1. Improvement in CGI [ Time Frame: 8 weeks ]
    CGI Improvement scale: 1=very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse

Secondary Outcome Measures :
  1. AISRS, Adult ADHD Investigator Rating Scale [ Time Frame: 8 weeks ]
    An 18 item clinician administered questionnaire to evaluate ADHD in adults. Responses to questions were 0-None, 1-Mild, 2-Moderate, 3-Severe. A decrease of 30% in the total score would be considered improvement. Total score range is 0-54. A lower score indicates improvement in symptoms. A score of 24 or more indicates symptomatic ADHD.

  2. The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) [ Time Frame: 8 weeks ]
    BRIEF-A is a 75 item self report questionnaire that measures behavior and executive function. For each item the subject is asked "during the past month, how often has each of the following behaviors been a problem?:" The choices are N (never), S (sometimes), O (Often). Total score for the Global Executive Composite used. Raw data were transformed into t-scores, which are standardized scores that indicate the number of standard deviations away from the mean. A T-score of 50 is equal to the mean. Values less than 65 indicate executive function is not a problem and values greater than 65 indicate executive function is often a problem.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Medication naïve male or female adults ages 18-55 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01733680

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United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
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Principal Investigator: Stephen V Faraone, PhD SUNY Upstate Medical Unversity
Principal Investigator: Prashant Kaul, MD VA Medical Center at Syracuse
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Responsible Party: State University of New York - Upstate Medical University Identifier: NCT01733680    
Other Study ID Numbers: 320969
First Posted: November 27, 2012    Key Record Dates
Results First Posted: July 20, 2018
Last Update Posted: July 20, 2018
Last Verified: October 2017
Keywords provided by State University of New York - Upstate Medical University:
executive function
emotional self-regulation
Additional relevant MeSH terms:
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Natriuretic Agents
Physiological Effects of Drugs
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Epithelial Sodium Channel Blockers
Diuretics, Potassium Sparing