Trial Outcomes & Findings for An Open-Label Study of Naltrexone in Adults With Attention Deficit Hyperactivity Disorder. (NCT NCT01873729)

Results Overview

The Adult Investigator Symptom Rating Scale (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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

Baseline and Six weeks

Results posted on

2017-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	Naltrexone Naltrexone Naltrexone: Adults with ADHD
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Naltrexone Naltrexone Naltrexone: Adults with ADHD
Overall Study Withdrawal by Subject	1

Baseline Characteristics

An Open-Label Study of Naltrexone in Adults With Attention Deficit Hyperactivity Disorder.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naltrexone n=3 Participants Naltrexone Naltrexone: Adults with ADHD
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	30.7 years STANDARD_DEVIATION 3.1 • n=5 Participants
Gender Female	1 Participants n=5 Participants
Gender Male	2 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Six weeks

The Adult Investigator Symptom Rating Scale (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).

Outcome measures

Outcome measures
Measure	Naltrexone n=2 Participants Naltrexone + Methylphenidate Spheroidal Oral Drug Absorption System (MPH-SODAS) Naltrexone: Adults with ADHD
Change in Adult Investigator Symptom Rating Scale (AISRS) Scores From Baseline	-5 Units on a scale Standard Deviation 5.7

SECONDARY outcome

Timeframe: Six weeks

The Clinical Global Impression (CGI) scale allows the clinician to rate the severity of illness, change over time, and efficacy of medication, taking into account the patient's clinical condition and the severity of side effects. The CGI subscales include the Clinical Global Severity of ADHD (CGI-S) which is scored on a 7 point scale (1=not ill, 7=extremely ill) and the Clinical Global Improvement of ADHD (CGI-I) which is also scored on a 7 point scale (1=very much improved, 7=very much worse). The number of subjects with CGI-Improvement scores less than or equal to 2 (very much improved) at the end of the study is reported.

Outcome measures

Outcome measures
Measure	Naltrexone n=2 Participants Naltrexone + Methylphenidate Spheroidal Oral Drug Absorption System (MPH-SODAS) Naltrexone: Adults with ADHD
Clinical Global Impression (CGI)	1 Participant

Adverse Events

Naltrexone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Thomas Spencer

Pediatric Psychopharmacology at Massachusetts General Hospital

Phone: 6177243883

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place