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

Completed · Phase 4

Conditions studied: ADHD

In brief

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.

Key facts

Study ID

NCT00586573

Run by

Massachusetts General Hospital

People needed

34

Starts

2007-03-01

Expected to finish

2009-10-01

Last updated by the study team

2012-06-07

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female outpatients 18-55 years of age
• 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.
• Subjects must score at least 14 on inattentive symptom questions on the DSM-IV based ADHD Rating Scale.
• Subjects who have an ADHD specific CGI Severity score of 4 or more (> moderately impaired).

You may not qualify if…

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

Where it is running

• Massachusetts General Hospital — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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