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
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