Official Title: “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 Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment

Study Primary Completion Date: May 2009

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 EFDs. Given its safety profile, and potential efficacy in cognition, memantine could offer therapeutic benefits for adults with ADHD. To this end, we are proposing an open-label pilot study of memantine in adult subjects with ADHD and ADHD Not Otherwise Specified (NOS) (late onset).

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.

Intervention(s) in this Clinical Trial

• Drug: memantine hydrochloride
  • tablet, 5-20 mg, twice daily, by mouth, 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A

Primary Measures

• DSM-IV ADHD Rating Scale
  • Time Frame: weekly
    Safety Issue?: No

Secondary Measures

• BRIEF-A
  • Time Frame: weeks 0, 2, 4, 8, 12
    Safety Issue?: No
• CANTAB
  • Time Frame: baseline, midpoint, end of study
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Massachusetts General Hospital

Overall Clinical Trial Officials and Contacts

Paul Hammerness, MD Principal Investigator MGH  

Overall Contact: Meghan Kotarski, MBA 617-503-1051 mkotarski@partners.org

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00586573

Study ID Number: 2007-P-000067

ClinicalTrials.gov Identifier: NCT00586573

Health Authority: United States: Food and Drug Administration