Asperger's Disorder, Autism, Pervasive Developmental Disorder NOS
Conditions
Keywords
Autism, Asperger's Disorder, Pervasive Developmental Disorder NOS, Adult, Memantine
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).
Interventions
DRUGmemantine
memantine 5-20 mg daily
DRUGPlacebo
Look-alike placebo
Sponsors
Forest Laboratories
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Global Impression-Scale(CGI-S) | 12 weeks |
Countries
United States
Participant flow
Pre-assignment details
4 participants were enrolled in this study. It was terminated prematurely and the P.I. was never un-blinded. In an attempt to enter the information which was obtained within the confines of the system, all enrollment information and baseline characteristics have been entered into the experimental arm.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Treatment as usual plus memantine
memantine: memantine 5-20 mg daily
OR
Treatment as usual plus Placebo | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Customized Age, years (18-85 | 4 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Clinical Global Impression-Scale(CGI-S)
Time frame: 12 weeks
Population: This study was terminated prematurely and data was not collected for this outcome measure.