Memantine for Executive Dysfunction in Adults With ADHD: A Pilot Study

Completed · Not applicable · Has a placebo group

Conditions studied: Attention Deficit Hyperactivity Disorder (ADHD), Executive Function Deficits (EFD)

In brief

This is a 12-week clinical trial evaluating the efficacy and safety of memantine hydrochloride (Namenda) in the treatment of executive function deficits (EFDs) in adults with Attention Deficit Hyperactivity Disorder (ADHD) receiving open-label treatment with OROS-Methylphenidate (OROS-MPH, Concerta). The study aims to examine the effects of treatment with memantine on ADHD symptoms. Following screening procedures, memantine is prescribed in randomized, double-blind fashion (equal chance of medication or placebo) for 12 weeks, along with open-label OROS-MPH (everyone receives medication).

Key facts

Study ID

NCT01533493

Run by

Massachusetts General Hospital

People needed

33

Starts

2012-05-01

Expected to finish

2013-08-01

Last updated by the study team

2014-04-08

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female adults ages 18-50 years
• A diagnosis of childhood onset ADHD, according to the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition (DSM-IV) based on clinical assessment
• A score of 20 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS)
• EFDs as established by at least 2 abnormal (>65) subscales of BRIEF-A

You may not qualify if…

• A history of non-response or intolerance to methylphenidate at adequate doses as determined by the clinician
• A history of non-response or intolerance to memantine at adequate doses as determined by the clinician
• Pregnant or nursing females
• A history of clinically unstable or significant other psychiatric conditions including suicidality, homicidality, bipolar disorder, psychosis, or current tic disorder, as judged by the clinician
• History of narrow angle glaucoma
• Current (within 3 months) DSM-IV criteria for substance abuse or dependence
• Medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including cardiovascular disease, hypertension, history of renal or hepatic impairment, organic brain disorders, or history of seizure disorder.
• Abnormal hematological or metabolic parameters
• IQ < 80
• Current use of any psychotropic medication
• Lack of facility with the English language
• Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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