ADHDEarly Phase 1NCT01733680
Amiloride Hydrochloride as an Effective Treatment for ADHD
A Early Phase 1 study testing amiloride and Behavioral in people with ADHD, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- ADHD
- What is being tested?
- amiloride and Behavioral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2015
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
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.
Read the 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.
- Conditions
- ADHD
- Being tested
- amiloride, Behavioral
- Keywords
- ADHD, executive function, emotional self-regulation
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amilorideDrug
Subjects will take either amiloride hydrochloride or placebo for 8 weeks.
BehavioralBehavioural
Also called ADHD symptoms, executive function, emotional self-regulation
Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement
| Study group | Role | What they receive |
|---|---|---|
| Amiloride | Active comparator | 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. Receives: Drug: amiloride; Behavioral: Behavioral |
| Placebo | Placebo comparator | Drug: Subjects will take placebo for 8 weeks Behavioral: Each week subjects will complete questionnaires: AISRS, BRIEF-A, and CGI Receives: Behavioral: Behavioral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in CGI
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
Measured: 8 weeks
Secondary outcomes (2)
AISRS, Adult ADHD Investigator Rating Scale
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.
Measured: 8 weeks
The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Study stopped due to lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen V Faraone, PhD, Principal investigator, SUNY Upstate Medical UnversityPrashant Kaul, MD, Principal investigator, VA Medical Center at Syracuse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733680
- Sponsor's protocol ID
- 320969
- Status last verified
- Oct 2017
- First submitted
- 20 Nov 2012
- Last updated
- 20 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amiloride Hydrochloride as an Effective Treatment for ADHD
- ClinicalTrials.gov ID
- NCT01733680
- Acronym / sponsor ID
- 320969
- Conditions
- ADHD
- Keywords
- ADHD, executive function, emotional self-regulation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to lack of recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Posted 20 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amiloride | Active comparator | Drug: amiloride, Behavioral: BehavioralDrug: 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. |
| Placebo | Placebo comparator | Behavioral: BehavioralDrug: Subjects will take placebo for 8 weeks Behavioral: Each week subjects will complete questionnaires: AISRS, BRIEF-A, and CGI |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amilorideSubjects will take either amiloride hydrochloride or placebo for 8 weeks. | Drug | Amiloride |
| BehavioralAlso: ADHD symptoms, executive function, emotional self-regulationEach week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement | Behavioural | Amiloride, Placebo |
Primary outcome
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
2 secondary outcomes
AISRS, Adult ADHD Investigator Rating Scale
Time frame: 8 weeks
The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen V Faraone, PhD principal investigator
SUNY Upstate Medical Unversity
Prashant Kaul, MD principal investigator
VA Medical Center at Syracuse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing amiloride and Behavioral in people with ADHD, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in CGI (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.