Phase 4
N=34
Open-Label Pilot Study of Namenda in Adult Subjects With ADHD and ADHD NOS
ADHD
Bottom Line
View on ClinicalTrials.gov: NCT00586573 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: DSM-IV ADHD Rating Scale (AISRS) Score Change — -17.5; -10.6; -6.9 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- memantine hydrochloride (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY DSM-IV ADHD Rating Scale (AISRS) Score Change |
-17.5; -10.6; -6.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00586573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.