Clinical trial NCT01333865: A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders
Official title: A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Autism Spectrum Disorders
Keywords: Memantine
Namenda
Autism Spectrum Disorders
Pervasive Developmental Disorders
Adults
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-04-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Number of Participants With Reduction in ASD Symptom Severity as Defined by the Social Responsiveness Scale (SRS)
timeFrame: Week 12
Secondary outcomes:
measure: Number of Participants With Reduction in ASD Symptom Severity as Defined by the NIMH Clinical Global Impression for Pervasive Developmental Disorders (CGI-PDD) Improvement Score
timeFrame: Pre-treatment - 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Gagan Joshi, MD
role: PRINCIPAL_INVESTIGATOR
References: