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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition ADHD
Interventions Drug: amiloride
Behavioral: Behavioral
Enrollment 3
Recruitment Details Subjects were recruited via a medical clinic and outside advertisement. Due to the stringent inclusion/exclusion criteria, we were only able to recruit 3 subjects and the physician who was conducting the study chose not to continue and we were unable to find another physician.
Pre-assignment Details  
Arm/Group Title Amiloride Placebo
Hide Arm/Group Description

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.

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

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

Drug: Subjects will take placebo for 8 weeks Behavioral: Each week subjects will complete questionnaires: AISRS, BRIEF-A, and CGI

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

Period Title: Overall Study
Started 2 1
Completed 2 0
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Arm 1-Amiloride Arm 2-Placebo Total
Hide Arm/Group Description Subjects received amiloride hydrochloride (5 mg for 2 weeks, 10 mg for 3 week, and 15 mg for 3 weeks. Subjects received placebo for 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 2 1 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
1
 100.0%
3
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Female
1
  50.0%
0
   0.0%
1
  33.3%
Male
1
  50.0%
1
 100.0%
2
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
2
 100.0%
1
 100.0%
3
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
2
 100.0%
1
 100.0%
3
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 1 participants 3 participants
2 1 3
CGI   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 2 participants 1 participants 3 participants
4.0
(4.0 to 4.0)
5
(5 to 5)
4.33
(4 to 5)
[1]
Measure Description:

Clinical Global Impressions (CGI)

  1. Normal, not at all ill
  2. Borderline mentally ill
  3. Mildly ill
  4. Moderately ill
  5. Markedly ill
  6. Severely ill
  7. Among the most extremely ill patients
1.Primary Outcome
Title Improvement in CGI
Hide Description 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
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
There was no statistical analysis done due to the small number of participants in the study
Arm/Group Title Amiloride Placebo
Hide Arm/Group Description:

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.

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

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

Drug: Subjects will take placebo for 8 weeks Behavioral: Each week subjects will complete questionnaires: AISRS, BRIEF-A, and CGI

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

Overall Number of Participants Analyzed 2 1
Mean (Full Range)
Unit of Measure: Units on a scale
CGI Week 3
4
(4 to 4)
5
(5 to 5)
CGI Week 4
4
(4 to 4)
3
(3 to 3)
CGI Week 5
4
(4 to 4)
5
(5 to 5)
CGI Week 6
3.5
(3 to 4)
5
(5 to 5)
CGI Week 7
4
(4 to 4)
5
(5 to 5)
CGI Week 8
3.5
(3 to 4)
5
(5 to 5)
CGI Week 9
3.5
(3 to 4)
5
(5 to 5)
CGI Week 10
3.5
(3 to 4)
5
(5 to 5)
2.Secondary Outcome
Title AISRS, Adult ADHD Investigator Rating Scale
Hide Description 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.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analysis of the outcome data was not done due to the small N.
Arm/Group Title Arm 1-Amiloride Arm 2-Placebo
Hide Arm/Group Description:
Amiloride was administered for 8 weeks. 5 mg for 2 weeks, 10 mg for 3 weeks and 15 mg for 3 weeks
Subjects were given placebo for 8 weeks
Overall Number of Participants Analyzed 2 1
Mean (Full Range)
Unit of Measure: Total score
Week 3
39
(30 to 48)
54
(54 to 54)
Week 4
38.5
(29 to 48)
51
(51 to 51)
Week 5
32.5
(18 to 47)
50
(50 to 50)
Week 6
31
(20 to 42)
50
(50 to 50)
Week 7
31
(17 to 45)
50
(50 to 50)
Week 8
34
(19 to 49)
50
(50 to 50)
Week 9
26
(14 to 38)
50
(50 to 50)
Week 10
32.5
(20 to 45)
50
(50 to 50)
3.Secondary Outcome
Title The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
Hide Description 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.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analysis of the outcome data was not done due to the small N of each group
Arm/Group Title Arm 1-Amiloride Arm 2-Placebo
Hide Arm/Group Description:
Subjects received amiloride hydrochloride for 8 weeks. 5 mg/day for 2 weeks, 10 mg/day for 3 weeks, and 15 mg/day for 3 weeks.
Subjects received placebo for 8 weeks
Overall Number of Participants Analyzed 2 1
Mean (90% Confidence Interval)
Unit of Measure: Global Executive Composite T Score
Week 3
66.5
(63.5 to 69.5)
95
(92 to 98)
Week 4
70.5
(67.5 to 73.5)
92
(89 to 95)
Week 5
68
(65 to 71)
96
(93 to 99)
Week 6
68.5
(65.5 to 71.5)
96
(93 to 99)
Week 7
62.5
(59.5 to 65.5)
96
(93 to 99)
Week 8
62.5
(59.5 to 65.5)
96
(93 to 99)
Week 9
62.5
(59.5 to 65.5)
96
(93 to 99)
Week 10
62
(59 to 65)
96
(93 to 99)
Time Frame 10 weeks
Adverse Event Reporting Description Adverse events that were monitored was blood pressure, weight, heart rate, EKG, CBC, TSH, lipid profile, BMP, general malaise, tiredness, headache.
 
Arm/Group Title Amiloride Placebo
Hide Arm/Group Description

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.

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

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

Drug: Subjects will take placebo for 8 weeks Behavioral: Each week subjects will complete questionnaires: AISRS, BRIEF-A, and CGI

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

All-Cause Mortality
Amiloride Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Amiloride Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Amiloride Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Because of the low number of subjects enrolled in the study, no outcome measures were statistically analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gail P DePalma
Organization: SUNy Upstate Medical University
Phone: 3154643260
EMail: depalmag@upstate.edu
Layout table for additonal information
Responsible Party: State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT01733680    
Other Study ID Numbers: 320969
First Submitted: November 20, 2012
First Posted: November 27, 2012
Results First Submitted: December 30, 2015
Results First Posted: July 20, 2018
Last Update Posted: July 20, 2018