search
Back to results

Memantine Monotherapy for Executive Dysfunction and ADHD

Primary Purpose

ADHD, Executive Function Deficits (EFD's)

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Memantine
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring ADHD, Executive function deficits, Psychiatry, Psychopharmacology, Namenda

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Memantine HCl

    Placebo

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Brief-A Self-Report

    Secondary Outcome Measures

    Full Information

    First Posted
    April 29, 2013
    Last Updated
    September 23, 2013
    Sponsor
    Massachusetts General Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01844427
    Brief Title
    Memantine Monotherapy for Executive Dysfunction and ADHD
    Official Title
    Memantine Monotherapy for Executive Dysfunction and ADHD: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2013
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    July 2013 (undefined)
    Primary Completion Date
    March 2015 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ADHD, Executive Function Deficits (EFD's)
    Keywords
    ADHD, Executive function deficits, Psychiatry, Psychopharmacology, Namenda

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Memantine HCl
    Arm Type
    Active Comparator
    Arm Description
    Memantine administered in capsule form twice daily for 12 weeks and titrated up to a maximum daily dose of 20mg.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Masked placebo administered in capsule form twice daily for 12 weeks. Placebo titration will be titrated according to the same procedure as active memantine.
    Intervention Type
    Drug
    Intervention Name(s)
    Memantine
    Other Intervention Name(s)
    Namenda
    Intervention Description
    Memantine HCl is an NMDA antagonist currently FDA approved for the treatment of moderate to severe Alzheimer's-type dementia.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Brief-A Self-Report
    Time Frame
    Baseline to 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male and female adults ages 18-45 years; a diagnosis of DSM-IV [78] ADHD-combined type 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); a BRIEF-A Global Executive Composite T-score of >6; and 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. -

    12. IPD Sharing Statement

    Learn more about this trial

    Memantine Monotherapy for Executive Dysfunction and ADHD

    We'll reach out to this number within 24 hrs