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OpenTrials
Completed

NCT Number: NCT01533493

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

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).

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Key information

Conditions

Attention Deficit Hyperactivity Disorder (ADHD) Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Executive Function Deficits (EFD) Mental Disorders Neurodevelopmental Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Placebo

Drug

Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.

Memantine Hydrochloride

Drug

Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.

Other names: Namenda

OROS-methylphenidate

Drug

OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment.

Other names: OROS-MPH, Concerta

Primary outcomes

  1. Percent Change in Global Executive Composite T-Score on the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)

    Time frame: baseline, 12 weeks

    This is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales: Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Example item: "I make careless errors when completing tasks." Items are rated 1 "Never," 2 "Sometimes," or 3 "Often." The Global Executive Composite (GEC) Score is calculated by totaling all items on the scale. GEC T-scores range from 34-108, with higher scores indicating more difficulties with executive function.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • The American Professional Society of ADHD and Related Disorders (APSARD)

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 15, 2012
Registry last updated
Apr 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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