Open-Label Pilot Study of Namenda in Adult Subjects With ADHD and ADHD NOS

May 2, 2012 updated by: Paul Hammerness, MD, Massachusetts General Hospital

An Open-Label Pilot Study of Namenda (Memantine Hydrochloride) in Adult Subjects With Attention Deficit Hyperactivity Disorder (ADHD) and ADHD NOS

The primary objective of the study is to assess the efficacy and tolerability of a 12-week trial of memantine hydrochloride administered twice daily in 20 adults (ages 18-55) with ADHD and ADHD NOS. Improvement will be defined as: 1) changes from baseline on the investigator-rated DSM-IV based ADHD Rating Scale; 2) changes from baseline in a questionnaire aimed at assessing executive functions (BRIEF); and 3) changes from screening in a computerized neuropsychological battery (CANTAB). We hypothesize that memantine hydrochloride will be associated with improving ADHD symptoms and associated deficits in executive functions. We also expect that memantine will be well-tolerated with predictable adverse events.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Memantine (Namenda) is a low-affinity N-methyl-D-aspartate (NMDA) receptor antagonist believed to work by blocking prolonged low-level activation of the NMDA receptor and resultant neuronal damage caused by abnormal glutamatergic activity, yet also allowing normal physiological activity of the NMDA channel. Memantine (Namenda) was approved by the U.S. Food and Drug Administration in 2003 for the treatment of moderate to severe Alzheimer's disease. Memantine improves or delays the decline in cognition (attention, language, visuo-spatial ability), as well as functional and behavioral symptoms in adults with moderate Alzheimer's disease.

Although the efficacy and safety of memantine has not been tested in people with ADHD, the spectrum of disorders possibly amenable to NMDA receptor antagonist treatment may include ADHD and associated executive function deficits (EFDs). To this end, we are proposing an open-label pilot study of memantine in adult subjects with ADHD and ADHD Not Otherwise Specified (NOS).

This will be a 12-week, open-label pilot study to assess the efficacy and tolerability of memantine hydrochloride (Namenda) administered to 20 adults 18-55 years of age with ADHD and ADHD NOS. All subjects that enter the study will undergo standard screening and diagnostic procedures. After obtaining written informed consent from the subject, the diagnosis of ADHD will be established through clinical evaluation by an expert clinician. Only consenting subjects satisfying inclusion and exclusion criteria will be included in the study.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female outpatients 18-55 years of age
  2. Subjects with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV or ADHD NOS (late onset; >7 years), as manifested in clinical evaluation and confirmed by structured interview.
  3. Subjects must score at least 14 on inattentive symptom questions on the DSM-IV based ADHD Rating Scale.
  4. Subjects who have an ADHD specific CGI Severity score of 4 or more (> moderately impaired).

Exclusion Criteria:

  1. Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including:
  2. History of Renal or Hepatic Impairment.
  3. Organic brain disorders.
  4. History of Seizure disorder.
  5. Any clinically unstable psychiatric conditions including the following: psychosis, suicidality, bipolar disorder, current substance use disorders (alcohol or drugs) or current tic disorder.
  6. Mental retardation (IQ <75).
  7. Pregnant or nursing females.
  8. Known hypersensitivity to memantine.
  9. Any current psychotropic treatment, with the exception of stable regimen of SSRIs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Namenda
Drug: memantine hydrochloride
tablet, 5-20 mg, twice daily, by mouth, 12 weeks
Other Names:
  • Namenda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DSM-IV ADHD Rating Scale (AISRS) Score Change
Time Frame: Endpoint, following 12 weeks Memantine Monotherapy

AISRS used to assess 18 individual criteria symptoms of ADHD in DSM-IV on a severity grid (0=not present, 3=severe; minimum score=0, maximum score=54). This is a composite score assessing both inattention and hyperactivity, which are not assessed individually in this scale.

Score change from baseline.
Endpoint, following 12 weeks Memantine Monotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Paul Hammerness, MD, MGH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

December 28, 2007

First Submitted That Met QC Criteria

December 28, 2007

First Posted (Estimate)

January 4, 2008

Study Record Updates

Last Update Posted (Estimate)

June 7, 2012

Last Update Submitted That Met QC Criteria

May 2, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-P-000067

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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