Amiloride Hydrochloride as an Effective Treatment for ADHD

• ClinicalTrials.gov Identifier: NCT01733680
• Recruitment Status: Terminated
• First Posted: November 27, 2012
• Results First Posted: July 20, 2018
• Last Update Posted: July 20, 2018
• Sponsor: State University of New York - Upstate Medical University
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Arm 1-Amiloride	Arm 2-Placebo	Total
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
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); Normal, not at all ill; Borderline mentally ill; Mildly ill; Moderately ill; Markedly ill; Severely ill; Among the most extremely ill patients

Outcome Measures

1. Primary Outcome

Title	Improvement in CGI
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

Outcome Measure Data

Analysis Population Description

There was no statistical analysis done due to the small number of participants in the study

Arm/Group Title	Amiloride	Placebo
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
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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)

Adverse Events

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
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	--/--	--/--
Serious Adverse Events
	Amiloride	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/2 (0.00%)	0/1 (0.00%)
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%)

Limitations and Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Gail P DePalma
• Organization: SUNy Upstate Medical University
• Phone: 3154643260
• EMail: depalmag@upstate.edu

• 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