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

This study has been completed.
Sponsor:
Collaborator:
The American Professional Society of ADHD and Related Disorders (APSARD)
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01533493
First received: February 8, 2012
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention
Attention Deficit Hyperactivity Disorder (ADHD)
Executive Function Deficits (EFD)
Drug: Placebo
Drug: Memantine Hydrochloride
Drug: OROS-Methylphenidate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Memantine for Executive Dysfunction in Adults With ADHD: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Percent Change in Global Executive Composite T-Score on the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 33
Study Start Date: May 2012
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate
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: 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
Active Comparator: Memantine
Subjects randomized to receive memantine in addition to open-label OROS-Methylphenidate
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533493

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
The American Professional Society of ADHD and Related Disorders (APSARD)
Investigators
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Joseph Biederman, MD, Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01533493     History of Changes
Other Study ID Numbers: 2012P000301
Study First Received: February 8, 2012
Results First Received: November 4, 2013
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
ADHD
Executive Function
Namenda
Concerta

Additional relevant MeSH terms:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Methylphenidate
Memantine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Antiparkinson Agents
Anti-Dyskinesia Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on October 19, 2014