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Memantine in Adult Autism Spectrum Disorder

Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Autism; Asperger's Disorder; Pervasive Developmental Disorder NOS

Intervention: memantine (Drug); Placebo (Drug)

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
Eric Samstad, MD, Principal Investigator, Affiliation: Johns Hopkins University

Summary

The purpose of this study is to see if memantine is helpful in managing problematic symptoms in adults with autism, Asperger's disorder, or Pervasive Developmental Disorder NOS.

Clinical Details

Official title: Memantine in Adult Autism Spectrum Disorder

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Clinical Global Impression-Scale(CGI-S)

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion criteria

- Participant is currently in treatment in the JHBMC ASNC

- Participant has a diagnosis of:

- Autistic Disorder

- Asperger's Disorder

- PDD NOS

- Participant meets one of the following criteria:

- CGI-S >= 4 (CGI-S: ________)

- Participant has the following problematic behaviors (at least one) that might be

expected to benefit from memantine: 1. _____________________________________________ 2. _____________________________________________ 3. _____________________________________________ Exclusion criteria The patient meets none of the following criteria (mark if absent):

- Active seizures (Patients with a history of seizures, who have been seizure-free on

an antiepileptic regimen for six months or more would be eligible).

- Rett's Syndrome or Childhood Disintegrative Disorder

- Active treatment with an acetylcholinesterase inhibitor

- Prior or current treatment with memantine

- Current treatment with lamotrigine

- Genetic, metabolic or degenerative disorder (excepting Fragile X).

- Brain malformation or known severe brain trauma

- Pregnancy or breastfeeding

- GFR < 30 mL/min

Locations and Contacts

Johns Hopkins Bayview, Baltimore, Maryland 21287, United States
Additional Information

Starting date: October 2009
Last updated: March 1, 2010

Page last updated: August 23, 2015

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