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Amiloride Hydrochloride as an Effective Treatment for ADHD

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
State University of New York - Upstate Medical University

Tracking Information
First Submitted Date  ICMJE November 20, 2012
First Posted Date  ICMJE November 27, 2012
Results First Submitted Date  ICMJE December 30, 2015
Results First Posted Date  ICMJE July 20, 2018
Last Update Posted Date July 20, 2018
Study Start Date  ICMJE September 2012
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 26, 2012)
Improvement in ADHD symptoms [ Time Frame: 8 weeks ]
Improvement in ADHD symptoms measured by the AISRS and the CGI scales.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2012)
Improvement in executive function and emotional self-regulation. [ Time Frame: 8 weeks ]
Measuring improvement in executive function and emotional self-regulation on the Behavior Rating Inventory of Executive Function - Adult Version
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amiloride Hydrochloride as an Effective Treatment for ADHD
Official Title  ICMJE Amiloride Hydrochloride as an Effective Treatment for ADHD
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE ADHD
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: amiloride
    • Behavioral: Behavioral
  • Placebo Comparator: Placebo
    Drug: Subjects will take placebo for 8 weeks Behavioral: Each week subjects will complete questionnaires: AISRS, BRIEF-A, and CGI
    Intervention: Behavioral: Behavioral
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 6, 2017)
3
Original Estimated Enrollment  ICMJE
 (submitted: November 26, 2012)
40
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01733680
Other Study ID Numbers  ICMJE 320969
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party State University of New York - Upstate Medical University
Study Sponsor  ICMJE State University of New York - Upstate Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen V Faraone, PhD SUNY Upstate Medical Unversity
Principal Investigator: Prashant Kaul, MD VA Medical Center at Syracuse
PRS Account State University of New York - Upstate Medical University
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP