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

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Autism Spectrum Disorders

Intervention: Memantine (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Gagan Joshi, MD, Principal Investigator, Affiliation: Massachusetts General Hospital

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.

Clinical Details

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

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With Reduction in ASD Symptom Severity as Defined by the Social Responsiveness Scale (SRS)

Secondary outcome: 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

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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.

Locations and Contacts

Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information

Starting date: January 2010
Last updated: September 30, 2014

Page last updated: August 23, 2015

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