Memantine for Executive Dysfunction in Adults With ADHD: A Pilot Study
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder (ADHD); Executive Function Deficits (EFD)
Intervention: Placebo (Drug); Memantine Hydrochloride (Drug); OROS-Methylphenidate (Drug)
Phase: N/A
Status: Completed
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
Joseph Biederman, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
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).
Clinical Details
Official title: Memantine for Executive Dysfunction in Adults With ADHD: A Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Percent Change in Global Executive Composite T-Score on the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Starting date: May 2012
Last updated: March 10, 2014
|
