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

Mass General Brigham

Status and phase

Completed

Phase 4

Conditions

Autism Spectrum Disorders

Treatments

Drug: Memantine

Study type

Interventional

Funder types

Other

Identifiers

NCT01333865

2010-P-000016

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.