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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Memantine

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.