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

NCT ID: NCT01533493

Last Updated: 2014-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-08-31

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

OROS-Methylphenidate

Intervention Type: 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.

Memantine

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

Group Type: ACTIVE_COMPARATOR

Memantine Hydrochloride

Intervention Type: 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.

OROS-Methylphenidate

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Namenda; OROS-MPH; Concerta

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The American Professional Society of ADHD and Related Disorders (APSARD)

UNKNOWN

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joseph Biederman, MD

Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Biederman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2012P000301

Identifier Type: -

Identifier Source: org_study_id