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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Memantine

Criteria

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.