Memantine in Adult Autism Spectrum Disorder

NCT01078844 | Terminated Results DMC

• 1 other identifier: NA_00015760
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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 not otherwise specified (NOS).

Conditions

Autism; Asperger's Disorder; Pervasive Developmental Disorder NOS

Keywords

Autism; Asperger's Disorder; Pervasive Developmental Disorder NOS; Adult; Memantine

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression-Scale(CGI-S)

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Treatment as usual plus placebo

Drug: Placebo

memantine

ACTIVE COMPARATOR

Treatment as usual plus memantine

Drug: memantine

Interventions

memantine DRUG

memantine 5-20 mg daily

memantine

Placebo DRUG

Look-alike placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is currently in treatment in the Johns Hopkins Bayview Medical Center (JHBMC)
• Participant has a diagnosis of:
• Autistic Disorder
• Asperger's Disorder
• Pervasive Developmental 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:
• \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
• \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
• \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

You may not qualify if:

• 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
• Glomerular Filtration Rate (GFR) \< 30 mL/min

Sponsors & Collaborators

• Johns Hopkins University: lead
• Forest Laboratories: collaborator

Study Sites (1)

Johns Hopkins Bayview

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Brignell A, Marraffa C, Williams K, May T. Memantine for autism spectrum disorder. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013845. doi: 10.1002/14651858.CD013845.pub2.

  PMID: 36006807 DERIVED

MeSH Terms

Conditions

Autistic Disorder; Asperger Syndrome; Child Development Disorders, Pervasive

Interventions

Memantine

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Eric Samstad, MD
• Organization: Johns Hopkins University School of Medicine

esamsta1@jhmi.edu

410-550-0171

Study Officials

• Eric Samstad, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 26, 2017
• Results First Posted: July 26, 2017

Record last verified: 2017-06

Locations

US (1)