CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 33 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Placebo 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01533493
NCT01533493N/ACompleted

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

Massachusetts General Hospital·interventional·Posted Feb 15, 2012·Updated Apr 8, 2014

In Brief

A clinical study evaluating Placebo, Memantine Hydrochloride, and 1 other intervention for Attention Deficit Hyperactivity Disorder (ADHD) and Executive Function Deficits (EFD). Completed, enrolled 33 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 15, 2012
Enrollment StartMay 1, 2012
Primary CompletionJul 1, 2013
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.4 years ago

Interventions

Placebodrug

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 Hydrochloridedrug

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.

OROS-Methylphenidatedrug

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.