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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586573
• Other study ID #: 2007-P-000067
• Status: Completed
• Phase: Phase 4
• First received: December 28, 2007
• Last updated: May 2, 2012
• Start date: March 2007
• Est. completion date: October 2009

Study information

• Verified date: May 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DSM-IV ADHD Rating Scale (AISRS) Score Change	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	No

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