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

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ClinicalTrials.gov Identifier: NCT01533493
Recruitment Status : Completed
First Posted : February 15, 2012
Results First Posted : February 21, 2014
Last Update Posted : April 8, 2014
Sponsor:
Collaborator:
The American Professional Society of ADHD and Related Disorders (APSARD)
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital

February 8, 2012
February 15, 2012
November 4, 2013
February 21, 2014
April 8, 2014
May 2012
July 2013   (Final data collection date for primary outcome measure)
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.
Change in Executive Functioning as measured by Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) [ Time Frame: baseline, 6, 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."
Complete list of historical versions of study NCT01533493 on ClinicalTrials.gov Archive Site
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Memantine for Executive Dysfunction in Adults With ADHD: A Pilot Study
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).
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Executive Function Deficits (EFD)
  • Drug: Placebo
    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.
  • Drug: Memantine Hydrochloride
    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 Name: Namenda
  • Drug: OROS-Methylphenidate
    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
  • Placebo Comparator: Placebo
    Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate
    Interventions:
    • Drug: Placebo
    • Drug: OROS-Methylphenidate
  • Active Comparator: Memantine
    Subjects randomized to receive memantine in addition to open-label OROS-Methylphenidate
    Interventions:
    • Drug: Memantine Hydrochloride
    • Drug: OROS-Methylphenidate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
20
August 2013
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01533493
2012P000301
No
Not Provided
Not Provided
Joseph Biederman, MD, Massachusetts General Hospital
Massachusetts General Hospital
The American Professional Society of ADHD and Related Disorders (APSARD)
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
Massachusetts General Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP