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A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01333865
First received: November 19, 2010
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

The main objective of this study is to evaluate the safety and effectiveness of memantine (Namenda®) for cognitive and behavioral impairment in adults ages 18-50 years with autism spectrum disorders (ASD). This is an exploratory, 12-week, pilot study, seeking to determine whether Namenda is efficacious and well tolerated in the treatment of adults with ASD. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.


Condition Intervention Phase
Autism Spectrum Disorders
Drug: Memantine
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Number of Participants With Reduction in ASD Symptom Severity as Defined by the Social Responsiveness Scale (SRS) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: January 2010
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Memantine (Namenda) Treatment Drug: Memantine

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusions

  • 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.

Exclusions

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333865

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Gagan Joshi, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Gagan Joshi, MD, Clinical Investigator, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01333865     History of Changes
Other Study ID Numbers: 2010-P-000016
Study First Received: November 19, 2010
Results First Received: September 15, 2014
Last Updated: September 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Memantine
Namenda
Autism Spectrum Disorders
Pervasive Developmental Disorders
Adults

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes
Memantine
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014