- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01733680
Amiloride Hydrochloride as an Effective Treatment for ADHD
Study Overview
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
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
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New York
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Syracuse, New York, United States, 13210
- SUNY Upstate Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Medication naïve male or female adults ages 18-55 years.
- A diagnosis of DSM-IV ADHD combined type based on clinical assessment by the study psychiatrist using the Conners Adult ADHD Diagnostic Interview;
- proficiency in English;
- A baseline score of 24 or more on the AISRS;
- ability to swallow pills;
- 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:
- have had pharmacologic treatment for ADHD in the past year;
- are pregnant or nursing;
- are Investigators or their immediate family (spouse, parent, child, grandparent, or grandchild);
- have any serious, unstable medical illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease;
- have severe allergies or multiple adverse drug reactions;
- have a current or past history of seizures;
- 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%);
- are judged by the study psychiatrist to be at serious suicidal risk.
- have current or past diagnoses of schizophrenia or bipolar disorder;
- have a history of hypersensitivity to amiloride or drug class members;
- have a history of hyperkalemia, diabetes mellitus, renal disease or anuria;
- have renal impairment Cr > 1.5; or
- are taking potassium supplements, aldosterone antagonists, tacrolimus or ACE inhibitors.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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. |
Subjects will take either amiloride hydrochloride or placebo for 8 weeks.
Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement
Other Names:
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Placebo Comparator: Placebo
Drug: Subjects will take placebo for 8 weeks Behavioral: Each week subjects will complete questionnaires: AISRS, BRIEF-A, and CGI
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Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in CGI
Time Frame: 8 weeks
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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
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AISRS, Adult ADHD Investigator Rating Scale
Time Frame: 8 weeks
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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.
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8 weeks
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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.
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8 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Stephen V Faraone, PhD, SUNY Upstate Medical Unversity
- Principal Investigator: Prashant Kaul, MD, VA Medical Center at Syracuse
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 320969
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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