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

NCT01873729 | Completed Phase 4 Results

• 1 other identifier: 2013P000696
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Naltrexone; Adults

Outcome Measures

Primary Outcomes (1)

• Change in Adult Investigator Symptom Rating Scale (AISRS) Scores From Baseline

  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).

  Baseline and Six weeks

Secondary Outcomes (1)

• Clinical Global Impression (CGI)

  Six weeks

Study Arms (1)

Naltrexone

EXPERIMENTAL

Naltrexone

Drug: Naltrexone

Interventions

Naltrexone DRUG

Adults with ADHD

Naltrexone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female outpatients 18-55 years of age.
• Diagnosis of ADHD, by DSM-IV by clinical evaluation by an expert clinician.
• Subjects treated for anxiety disorders and depression who are on a stable medication regimen for at least one month, and who have a disorder-specific CGI-Severity score ≤ 3 (mildly ill) and who have a score on the Hamilton-Depression and Hamilton-Anxiety rating scales below 15 (mild range).

You may not qualify if:

• Any clinically unstable psychiatric conditions including any history of psychosis or mania, suicidality, sociopathy, criminality, or delinquency.
• Current (last 3 months) substance use disorders (alcohol or drugs),
• Medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study including cardiovascular disease, current untreated hypertension, history of renal or hepatic impairment, or a condition that will or may require treatment with opioid analgesics.
• Clinically significant abnormal baseline laboratory LFT's, which is defined as LFT's greater than the ULN.
• Mental retardation (IQ \< 80).
• Organic brain disorders including delirium, dementia, seizures, stroke, neurosurgery, and head trauma with loss of consciousness.
• Pregnant or nursing females.
• Subjects with current adequate treatment for ADHD.
• Current treatment with medication for ADHD.
• Any other concomitant medication with primarily central nervous system activity other than specified in the protocol (a stable and effective treatment regimen of an SSRI or benzodiazepine is permitted per clinical review.)
• Subjects presenting with a CGI-Severity score of 6 (severely ill) at two consecutive visits after week 2 will be dropped from the study (i.e. A subject with a CGI of 6 at his/her week 3 visit and at week 4 visit will be dropped from the study at the week 4 visit). Subjects who are dropped for severe or worsening symptoms after exposure to the study medication will receive free follow up care as described in the detailed protocol and protocol summary.
• Non-English speaking subjects

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Thomas Spencer
• Organization: Pediatric Psychopharmacology at Massachusetts General Hospital

tspencer@partners.org

6177243883

Study Officials

• Thomas Spencer, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: June 10, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 13, 2017
• Results First Posted: September 20, 2016

Record last verified: 2016-11

Locations

US (1)