Memantine for the Treatment of Social Deficits in Youth With Disorders of Impaired Social Interactions

This is an interventional treatment trial for Autism focused on measuring Autism, Massachusetts General Hospital Read More

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.