A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders
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|ClinicalTrials.gov Identifier: NCT01333865|
Recruitment Status : Completed
First Posted : April 12, 2011
Results First Posted : October 6, 2014
Last Update Posted : March 24, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorders||Drug: Memantine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
|Experimental: Memantine (Namenda) Treatment||
Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer's disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.
During the 12 weeks of study duration, subjects will be evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine will be administered in divided dose twice a day in the morning and evening. Titration of study medication will be guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects will be evaluated.
Other Name: Namenda
- Number of Participants With Reduction in ASD Symptom Severity as Defined by the Social Responsiveness Scale (SRS) [ Time Frame: Week 12 ]
Number of participants with reduction in ASD symptom severity defined as a reduction in Social Responsiveness Scale (SRS) score from baseline of greater than or equal to 30%.
The SRS is a 65-item rating scale completed by an informant to measure the severity of autism spectrum symptoms as they occur in natural settings.
- Number of Participants With Reduction in ASD Symptom Severity as Defined by the NIMH Clinical Global Impression for Pervasive Developmental Disorders (CGI-PDD) Improvement Score [ Time Frame: Pre-treatment - 12 weeks ]Number of participants with reduction in ASD symptom severity defined as an NIMH Clinical Global Impression (CGI) Pervasive Developmental Disorder (PDD) Improvement score less than or equal to 2. The CGI-Improvement is a clinician-rated measure of improvement. Scores range from 1 (very much improved) to 7 (very much worse) for PDD.
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|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Male and female outpatients 18-50 years of age.
- Participants must have DSM-IV-TR diagnosis of PDD and displaying PDD symptoms with at least moderate impairment (SRS score ≥ 85 and CGI-PDD ≥ 4).
- Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria of autistic disorder (with the exception of a total lack of spoken language), Asperger's disorder, or PDD-NOS as established by clinical interview and confirmed by DICA-R PDD module.
- Subjects and/or their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
- Subjects and/or their legal representative must be considered reliable reporters.
- Each subject and/or their authorized legal representative must understand the nature of the study. The subject and/or their legal representative must sign an informed consent document.
- Subject must be able to participate in mandatory blood draws.
- Subject must be able to swallow pills.
- Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.
- IQ < 85.
- Total lack of spoken language.
- DSM-IV-TR PDD diagnoses of Rett's disorder, or childhood disintegrative disorder.
- Clinically unstable psychiatric conditions or judged to be at serious suicidal risk.
- Active symptoms of anorexia or bulimia nervosa
- Current diagnosis of a psychotic disorder or unstable bipolar disorder.
- History of recent or current (past 30 days) clinically significant depressive or anxiety disorder that warrants treatment.
- Current diagnosis of schizophrenia.
- History of substance use (except nicotine or caffeine) within past 3 months
- Serious, stable or unstable systemic illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- Subjects with severe hepatic impairment (LFTs > 3 times ULN) and those with severely impaired renal function (eGFR < 30).
- Subjects with genitourinary conditions that raise urine pH (e.g., renal tubular acidosis, severe infection of the urinary tract).
- Uncorrected hypothyroidism or hyperthyroidism.
- Subjects with untreated and/or unstable diabetes.
- Non-febrile seizures without a clear and resolved etiology.
- Pregnant or nursing females.
- Known hypersensitivity to memantine.
- Severe allergies or multiple adverse drug reactions.
- A non-responder or history of intolerance to memantine, after treatment at adequate doses as determined by the clinician.
- Investigator and his/her immediate family defined as the investigator's spouse, parent, child, grandparent, or grandchild.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333865
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Gagan Joshi, MD||Massachusetts General Hospital|
|Responsible Party:||Gagan Joshi, MD, Clinical Investigator, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital|
|Other Study ID Numbers:||
|First Posted:||April 12, 2011 Key Record Dates|
|Results First Posted:||October 6, 2014|
|Last Update Posted:||March 24, 2016|
|Last Verified:||February 2016|
Autism Spectrum Disorders
Pervasive Developmental Disorders
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents