Memantine Monotherapy for Executive Dysfunction and ADHD

NCT ID: NCT01844427

Last Updated: 2013-09-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31

Brief Summary

This is a 12-week clinical trial evaluating the efficacy and safety of memantine hydrochloride (Memantine HC1, brand name Namenda) in the treatment of executive function deficits (EFDs) in adults with Attention Deficit Hyperactivity Disorder (ADHD). After screening procedures, memantine is prescribed in randomized, double-blind fashion (equal chance of medication or placebo) for 12 weeks.

The investigators hypothesize that memantine hydrochloride will prove to be an effective, safe, and well-tolerated agent for the treatment of EFDs in individuals with ADHD interested in non-stimulant medications.

Conditions

ADHD; Executive Function Deficits (EFD's)

Keywords

ADHD; Executive function deficits; Psychiatry; Psychopharmacology; Namenda

Study Design

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

Study Groups

Memantine HCl

Memantine administered in capsule form twice daily for 12 weeks and titrated up to a maximum daily dose of 20mg.

Group Type: ACTIVE_COMPARATOR

Memantine

Intervention Type: DRUG

Memantine HCl is an NMDA antagonist currently FDA approved for the treatment of moderate to severe Alzheimer's-type dementia.

Placebo

Masked placebo administered in capsule form twice daily for 12 weeks. Placebo titration will be titrated according to the same procedure as active memantine.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Memantine

Memantine HCl is an NMDA antagonist currently FDA approved for the treatment of moderate to severe Alzheimer's-type dementia.

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Namenda

Eligibility Criteria

Inclusion Criteria

1. Male and female adults ages 18-45 years;

2. a diagnosis of DSM-IV [78] ADHD-combined type

3. a score of at least 20 on the AISRS (a score of 20 in the AISRS identifies subjects with at least moderate severity of symptoms);

4. a BRIEF-A Global Executive Composite T-score of >6; and

5. proficiency in English. -

Exclusion Criteria

1) Pregnant or nursing females; 2) investigator and his/her immediate family (spouse, parent, child, grandparent, or grandchild); 3) any serious, unstable medical illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease and hypertension), endocrinologic, neurologic, immunologic, or hematologic disease; 4) hypersensitivity to memantine; 5) multiple adverse drug reactions; 6) current or past history of seizures; 7) any history of a major psychiatric disorder including schizophrenia, psychosis, bipolar disorder (BPD), or autism spectrum disorder (ASD); 8) meets DSM-IV criteria in the last month for major depression or any major anxiety disorder or has a Hamilton Rating Scale for Anxiety (HAM-A) or Hamilton Rating Scale for Depression (HAM-D) score greater than 14; 9) meets DSM-IV criteria for substance abuse or dependence in the last month or has a positive drug urine screen; 10) judged to be at serious suicidal risk; 11) use of any other concomitant medication with primarily central nervous system activity; or 12) IQ < 80.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joseph Biederman, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Countries

United States

Other Identifiers

2013P000520

Identifier Type: -

Identifier Source: org_study_id