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

Phase 4

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Drug: Naltrexone

• Registration Number: NCT01873729
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The primary aim of this study is to assess whether naltrexone as a monotherapy is effective in treating Attention Deficit Hyperactivity Disorder (ADHD) in adults. Medications that increase dopamine are often effective in treating ADHD in adults. Since naltrexone is a kappa opioid receptor antagonist, it increases dopamine in the brain.

We predict that naltrexone as a monotherapy will be effective for ADHD symptoms in adults with ADHD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-06
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-10
• Study Start: 2013-11
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2016-07-29
• Results First Submitted QC: 2016-07-29
• Results First Posted: 2016-09-20
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Naltrexone	Naltrexone	Naltrexone

Primary Outcome Measures

Name	Time	Method
Change in Adult Investigator Symptom Rating Scale (AISRS) Scores From Baseline	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).

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression (CGI)	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States