Amiloride Hydrochloride as an Effective Treatment for ADHD

NCT01733680 | Terminated Early Phase 1 Results DMC

• 1 other identifier: 320969
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

ADHD; executive function; emotional self-regulation

Outcome Measures

Primary Outcomes (1)

• 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

  8 weeks

Secondary Outcomes (2)

• AISRS, Adult ADHD Investigator Rating Scale

  8 weeks

• The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)

  8 weeks

Study Arms (2)

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.

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

Behavioral: Behavioral

Interventions

amiloride DRUG

Subjects will take either amiloride hydrochloride or placebo for 8 weeks.

Amiloride

Behavioral BEHAVIORAL

Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement

Also known as: ADHD symptoms, executive function, emotional self-regulation

Amiloride; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Emotional Regulation

Interventions

Amiloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Because of the low number of subjects enrolled in the study, no outcome measures were statistically analyzed.

Results Point of Contact

• Title: Gail P DePalma
• Organization: SUNy Upstate Medical University

depalmag@upstate.edu

3154643260

Study Officials

• Stephen V Faraone, PhD

  SUNY Upstate Medical Unversity

  PRINCIPAL INVESTIGATOR

• Prashant Kaul, MD

  VA Medical Center at Syracuse

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 27, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 20, 2018
• Results First Posted: July 20, 2018

Record last verified: 2017-10

Locations

US (1)