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

NCT01533493 | Completed Results

• 1 other identifier: 2012P000301
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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).

Conditions

Attention Deficit Hyperactivity Disorder (ADHD); Executive Function Deficits (EFD)

Keywords

ADHD; Executive Function; Namenda; Concerta

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate

Drug: Placebo; Drug: OROS-Methylphenidate

Memantine

ACTIVE COMPARATOR

Subjects randomized to receive memantine in addition to open-label OROS-Methylphenidate

Drug: Memantine Hydrochloride; Drug: OROS-Methylphenidate

Interventions

Placebo DRUG

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.

Placebo

Memantine Hydrochloride DRUG

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

Memantine

OROS-Methylphenidate DRUG

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

Memantine; Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• The American Professional Society of ADHD and Related Disorders (APSARD): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Memantine; Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Joseph Biederman
• Organization: Massachusetts General Hospital

jbiederman@partners.org

617-724-1743

Study Officials

• Joseph Biederman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: February 15, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 8, 2014
• Results First Posted: February 21, 2014

Record last verified: 2014-03

Locations

US (1)