a study of memantine hydrochloride (namenda®) for cognitive and behavioral impairment in adults with autism spectrum disorders

Conditions: Autism Spectrum Disorders

Summary: the main objective of this study is to evaluate the safety and effectiveness of memantine (namenda®) for cognitive and behavioral impairment in adults ages 18-50 years with autism spectrum disorders (asd). this is an exploratory, 12-week, pilot study, seeking to determine whether namenda is efficacious and well tolerated in the treatment of adults with asd. the study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.


Eligibility criteria:
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.

Keywords: memantine namenda autism spectrum disorders pervasive developmental disorders adults