A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders

This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring Memantine, Namenda, Autism Spectrum Disorders, Pervasive Developmental Disorders, Adults Read More

Inclusions

• Male and female outpatients 18-50 years of age.
• Participants must have DSM-IV-TR diagnosis of PDD and displaying PDD symptoms with at least moderate impairment (SRS score ≥ 85 and CGI-PDD ≥ 4).
• Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria of autistic disorder (with the exception of a total lack of spoken language), Asperger's disorder, or PDD-NOS as established by clinical interview and confirmed by DICA-R PDD module.
• Subjects and/or their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
• Subjects and/or their legal representative must be considered reliable reporters.
• Each subject and/or their authorized legal representative must understand the nature of the study. The subject and/or their legal representative must sign an informed consent document.
• Subject must be able to participate in mandatory blood draws.
• Subject must be able to swallow pills.
• Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.

Exclusions

• IQ < 85.
• Total lack of spoken language.
• DSM-IV-TR PDD diagnoses of Rett's disorder, or childhood disintegrative disorder.
• Clinically unstable psychiatric conditions or judged to be at serious suicidal risk.
• Active symptoms of anorexia or bulimia nervosa
• Current diagnosis of a psychotic disorder or unstable bipolar disorder.
• History of recent or current (past 30 days) clinically significant depressive or anxiety disorder that warrants treatment.
• Current diagnosis of schizophrenia.
• History of substance use (except nicotine or caffeine) within past 3 months
• 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) and those with severely impaired renal function (eGFR < 30).
• Subjects with genitourinary conditions that raise urine pH (e.g., renal tubular acidosis, severe infection of the urinary tract).
• Uncorrected hypothyroidism or hyperthyroidism.
• Subjects with untreated and/or unstable diabetes.
• Non-febrile seizures without a clear and resolved etiology.
• Pregnant or nursing females.
• Known hypersensitivity to memantine.
• Severe allergies or multiple adverse drug reactions.
• A non-responder or history of intolerance to memantine, after treatment at adequate doses as determined by the clinician.
• Investigator and his/her immediate family defined as the investigator's spouse, parent, child, grandparent, or grandchild.