Memantine for Executive Dysfunction in Adults With ADHD: A Pilot Study
This study is ongoing, but not recruiting participants.
Sponsor:
Massachusetts General Hospital
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: May 2, 2013
Last verified: May 2013
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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: Single Group 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:
MedlinePlus related topics:
Attention Deficit Hyperactivity Disorder
Drug Information available for:
Methylphenidate
Methylphenidate hydrochloride
Memantine
Memantine hydrochloride
U.S. FDA Resources
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Change in Executive Functioning as measured by Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) [ Time Frame: baseline, 6, 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."
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 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 dimentia, 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:
|
|
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 dimentia, 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:
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
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 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
ADHD Executive Function Namenda Concerta |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Memantine Methylphenidate Dopamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Central Nervous System Stimulants |
ClinicalTrials.gov processed this record on May 16, 2013