Trial Outcomes & Findings for A Double-Blind Comparison of Naltrexone and Placebo in Adults With Attention Deficit Hyperactivity Disorder (NCT 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

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

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

PRIMARY outcome

Timeframe: 6 weeks

Population: 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.

Outcome measures

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

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

Leah Feinberg

Massachusetts General Hospital

Phone: 617-726-4651

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

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=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	36.33 years STANDARD_DEVIATION NA • n=5 Participants	32.21 years STANDARD_DEVIATION 2.13 • n=7 Participants	33.58 years STANDARD_DEVIATION 2.61 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants