Trial Outcomes & Findings for A Double-Blind Comparison of Naltrexone and Placebo in Adults With Attention Deficit Hyperactivity Disorder (NCT NCT01721330)
NCT ID: NCT01721330
Last Updated: 2016-05-27
Results Overview
The AISRS is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). We measured the change in AISRS score from baseline to week 6.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
3 participants
Primary outcome timeframe
6 weeks
Results posted on
2016-05-27
Participant Flow
Participant milestones
| Measure |
Naltrexone
Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.
Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks
|
Placebo
Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.
Placebo: Placebo twice a day for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Naltrexone
Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.
Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks
|
Placebo
Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.
Placebo: Placebo twice a day for 6 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Double-Blind Comparison of Naltrexone and Placebo in Adults With Attention Deficit Hyperactivity Disorder
Baseline characteristics by cohort
| Measure |
Naltrexone
n=1 Participants
Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.
Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks
|
Placebo
n=2 Participants
Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.
Placebo: Placebo twice a day for 6 weeks
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
36.33 years
STANDARD_DEVIATION NA • n=99 Participants
|
32.21 years
STANDARD_DEVIATION 2.13 • n=107 Participants
|
33.58 years
STANDARD_DEVIATION 2.61 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: One subject withdrew from the study before receiving study medication, so data from only two subjects was analyzed (one subject in each group). Therefore, means and standard deviations were not calculated.
The AISRS is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). We measured the change in AISRS score from baseline to week 6.
Outcome measures
| Measure |
Naltrexone
n=1 Participants
Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.
Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks
|
Placebo
n=1 Participants
Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.
Placebo: Placebo twice a day for 6 weeks
|
|---|---|---|
|
Change in Adult Investigator Symptom Rating Scale (AISRS) Score
|
-6.0 units on a scale
|
-5.0 units on a scale
|
Adverse Events
Naltrexone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naltrexone
n=1 participants at risk
Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.
Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks
|
Placebo
n=2 participants at risk
Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.
Placebo: Placebo twice a day for 6 weeks
|
|---|---|---|
|
General disorders
Flu
|
100.0%
1/1 • Number of events 1
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
Muscle ache
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Headache
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place