Back to resultsMemantine for Executive Dysfunction in Adults With ADHD: A Pilot Study
Primary Purpose
Attention Deficit Hyperactivity Disorder (ADHD), Executive Function Deficits (EFD)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
Memantine Hydrochloride
OROS-Methylphenidate
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD) focused on measuring ADHD, Executive Function, Namenda, Concerta
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Memantine
Arm Description
Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate
Subjects randomized to receive memantine in addition to open-label OROS-Methylphenidate
Outcomes
Primary Outcome Measures
Percent Change in Global Executive Composite T-Score on the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01533493
First Posted
February 8, 2012
Last Updated
March 10, 2014
Sponsor
Massachusetts General Hospital
Collaborators
The American Professional Society of ADHD and Related Disorders (APSARD)
1. Study Identification
Unique Protocol Identification Number
NCT01533493
Brief Title
Memantine for Executive Dysfunction in Adults With ADHD: A Pilot Study
Official Title
Memantine for Executive Dysfunction in Adults With ADHD: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
The American Professional Society of ADHD and Related Disorders (APSARD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder (ADHD), Executive Function Deficits (EFD)
Keywords
ADHD, Executive Function, Namenda, Concerta
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate
Arm Title
Memantine
Arm Type
Active Comparator
Arm Description
Subjects randomized to receive memantine in addition to open-label OROS-Methylphenidate
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Memantine Hydrochloride
Other Intervention Name(s)
Namenda
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
OROS-Methylphenidate
Other Intervention Name(s)
OROS-MPH, Concerta
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Change in Global Executive Composite T-Score on the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
Description
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.
Time Frame
baseline, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Biederman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Memantine for Executive Dysfunction in Adults With ADHD: A Pilot Study
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