A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders
This trial is active, not recruiting.
|Condition||autism spectrum disorders|
|Sponsor||Massachusetts General Hospital|
|Start date||January 2010|
|End date||January 2014|
|Trial size||20 participants|
|Trial identifier||NCT01333865, 2010-P-000016|
The main objective of this study is to evaluate the safety and effectiveness of memantine (Namenda®) for cognitive and behavioral impairment in adults ages 18-45 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.
|Intervention model||single group assignment|
Reduction in ASD symptom severity
time frame: Week 12
Male or female participants from 18 years up to 50 years old.
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.
|Official title||A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders|
|Principal investigator||Gagan Joshi, MD|
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