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

Mass General Brigham

Status: Completed

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

Treatments: Drug: OROS-Methylphenidate; Drug: Placebo; Drug: Memantine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01533493

2012P000301

Details and patient eligibility

About

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).

Enrollment: 33 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. A history of non-response or intolerance to methylphenidate at adequate doses as determined by the clinician
2. A history of non-response or intolerance to memantine at adequate doses as determined by the clinician
3. Pregnant or nursing females
4. 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
5. History of narrow angle glaucoma
6. Current (within 3 months) DSM-IV criteria for substance abuse or dependence
7. 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.
8. Abnormal hematological or metabolic parameters
9. IQ < 80
10. Current use of any psychotropic medication
11. Lack of facility with the English language
12. Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate

Treatment:

Drug: Placebo

Drug: OROS-Methylphenidate

Memantine

Active Comparator group

Description:

Subjects randomized to receive memantine in addition to open-label OROS-Methylphenidate

Treatment:

Drug: Memantine Hydrochloride

Drug: OROS-Methylphenidate