Memantine in Adult Autism Spectrum Disorder

NCT ID: NCT01078844

Last Updated: 2017-07-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Treatment as usual plus placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Look-alike placebo

memantine

Treatment as usual plus memantine

Group Type: ACTIVE_COMPARATOR

memantine

Intervention Type: DRUG

memantine 5-20 mg daily

Interventions

memantine

memantine 5-20 mg daily

Intervention Type: DRUG

Placebo

Look-alike placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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:

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Samstad, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36006807 (View on PubMed)

Other Identifiers

NA_00015760

Identifier Type: -

Identifier Source: org_study_id