An interventional study of Placebo and Memantine Hydrochloride in Attention Deficit Hyperactivity Disorder (ADHD) and Executive Function Deficits (EFD), sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2014-04-08.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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).
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's enrollment of 33 is below the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate
Drug: Placebo · Drug: OROS-Methylphenidate
Subjects randomized to receive memantine in addition to open-label OROS-Methylphenidate
Drug: Memantine Hydrochloride · Drug: OROS-Methylphenidate
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 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.
Also known as: Namenda
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.
Also known as: OROS-MPH, Concerta
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.
Time frame: baseline, 12 weeks
| Milestone | Memantine | Placebo |
|---|---|---|
| Started | 12 | 14 |
| Completed | 7 | 11 |
| Not completed | 5 | 3 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Lost to follow-up | 2 | 0 |
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.
| percentage change from baseline score | Memantine | Placebo |
|---|---|---|
| Percent Change in Global Executive Composite T-Score on the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) | -24 ± 0.169 | -21 ± 0.132 |
Collected over Adverse events were collected weekly, up to 12 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Memantine | — | 0/12 (0%) | 10/12 (83.3%) |
| Placebo | — | 0/14 (0%) | 13/14 (92.9%) |
| Event | Memantine | Placebo |
|---|---|---|
| Appetite DecreaseMetabolism and nutrition disorders | 5/12 | 8/12 |
| Dry MouthGeneral disorders | 6/12 | 6/14 |
| HeadacheGeneral disorders | 6/12 | 2/14 |
| InsomniaGeneral disorders | 3/12 | 6/14 |
| FatigueGeneral disorders | 4/12 | 3/14 |
| Heart PalpitationsCardiac disorders | 4/12 | 4/14 |
| JitteryMusculoskeletal and connective tissue disorders | 2/12 | 4/14 |
| Head discomfortGeneral disorders | 1/12 | 3/14 |
| AnxietyPsychiatric disorders | 2/12 | 2/14 |
| DizzinessGeneral disorders | 2/12 | 0/14 |
| Age, Categorical(Participants) | Memantine | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 14 | 26 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Memantine | Placebo | Total |
|---|---|---|---|
| Mean | 34.25 ± 9.77 | 38.43 ± 10.57 | 36.5 ± 10.23 |
| Sex: Female, Male(Participants) | Memantine | Placebo | Total |
|---|---|---|---|
| Female | 7 | 7 | 14 |
| Male | 5 | 7 | 12 |
| Region of Enrollment(participants) | Memantine | Placebo | Total |
|---|---|---|---|
| United States | 12 | 14 | 26 |
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity→
Massachusetts General Hospital