Boston, Massachusetts 02114

  • Nonverbal Learning Disability

Purpose:

This study is a 12-week randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment of social impairment in youth with Non-Verbal Learning Disorder, High-Functioning Autism Spectrum Disorder, and related conditions. Eligible participants will be males and females ages 8-18. This study consists of up to 6 visits to Massachusetts General Hospital.


Criteria:

Inclusion Criteria: - Male & female subjects ages 8-18 years (inclusive). - Diagnostic Statistical Manual (DSM)-5 Autism Spectrum Disorder (ASD) diagnostic criteria as established by clinical diagnostic interview - At least moderate severity of social impairment as measured by a total raw score of ≥85 on the parent/guardian-completed Social Responsiveness Scale-Second Edition (SRS-2)14 and a score of ≥4 on the clinician-administered Clinical Global Impression-Severity scale (CGI-S)17. Exclusion Criteria: - IQ ≤70 based on the Wechsler Abbreviated Scale of Intelligence-II (WASI-II) Vocabulary and Matrix Reasoning subtests - Impaired communicative speech - Subjects currently treated with the following medications (known to impact glutamate levels): Lamotrigine, Amantadine, N-acetylcysteine, D-cycloserine - Subjects treated with a psychotropic medication not listed above on a dose that has not been stable for at least 4 weeks prior to study baseline. - Co-administration of drugs that compete with memantine for renal elimination using the same renal cationic system, including hydrochlorothiazide, triamterene, metformin, cimetidine, ranitidine, quinidine, and nicotine - Initiation of a new psychosocial intervention within 30 days prior to randomization. - Subjects who are pregnant and/or nursing. - Subjects with a history of non-febrile seizures without a clear and resolved etiology. - Subjects with a history of or a current liver or kidney disease. - Clinically unstable psychiatric conditions or judged to be at serious suicidal risk. - Subjects who meet on the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS-E) for alcohol or drug dependence or abuse. If the subject has a recent history of substance abuse, there will be a two-week washout period before initiating the trial as an added precaution. There are no known safety issues relating to memantine and recent history of substance abuse. - Serious, stable or unstable systemic illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease. - Subjects with severe hepatic impairment (LFTs > 3 times ULN). - Subjects with genitourinary conditions that raise urine pH (e.g., renal tubular acidosis, severe infection of the urinary tract). - Known hypersensitivity to memantine. - Severe allergies or multiple adverse drug reactions. - A history of intolerance or adequate exposure to memantine, as determined by the clinician. - Investigator and his/her immediate family defined as the investigator's spouse, parent, child, grandparent, or grandchild.


NCT ID:

NCT03553875


Primary Contact:

Principal Investigator
Gagan Joshi, MD
Massachusetts General Hospital

Allison Green, BA
Phone: 617-724-7301
Email: agreen14@mgh.harvard.edu


Backup Contact:

Email: claw3@mgh.harvard.edu
Cecilia Law, BA
Phone: 617-724-2551


Location Contact:

Boston, Massachusetts 02114
United States

Allison Green, BA
Phone: 617-724-7301
Email: agreen14@mgh.harvard.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 23, 2021

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