Memantine in Adult Autism Spectrum Disorder

This study is enrolling participants by invitation only.
Forest Laboratories
Information provided by:
Johns Hopkins University Identifier:
First received: March 1, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
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.

Condition Intervention
Asperger's Disorder
Pervasive Developmental Disorder NOS
Drug: memantine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Memantine in Adult Autism Spectrum Disorder

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Clinical Global Impression-Scale(CGI-S) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Treatment as usual plus placebo
Drug: Placebo
Look-alike placebo
Active Comparator: memantine
Treatment as usual plus memantine
Drug: memantine
memantine 5-20 mg daily


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion criteria

  • Participant is currently in treatment in the JHBMC ASNC
  • Participant has a diagnosis of:
  • Autistic Disorder
  • Asperger's Disorder
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01078844

United States, Maryland
Johns Hopkins Bayview
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Forest Laboratories
Principal Investigator: Eric Samstad, MD Johns Hopkins University
  More Information

Responsible Party: Eric Samstad, MD, Johns Hopkins University Identifier: NCT01078844     History of Changes
Other Study ID Numbers: NAM_MD_69 
Study First Received: March 1, 2010
Last Updated: March 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
Asperger's Disorder
Pervasive Developmental Disorder NOS

Additional relevant MeSH terms:
Autism Spectrum Disorder
Autistic Disorder
Child Development Disorders, Pervasive
Developmental Disabilities
Mental Disorders
Neurodevelopmental Disorders
Asperger Syndrome
Pathologic Processes
Anti-Dyskinesia Agents
Antiparkinson Agents
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on May 22, 2016