Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Memantine for the Treatment of Social Deficits in Youth With Disorders of Impaired Social Interactions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553875
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Gagan Joshi, Massachusetts General Hospital

Brief Summary:

This study is a 12-week randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment of social impairment in youth with Non-Verbal Learning Disorder, High-Functioning Autism Spectrum Disorder, and related conditions. Eligible participants will be males and females ages 8-18.

This study consists of up to 6 visits to Massachusetts General Hospital.


Condition or disease Intervention/treatment Phase
Autism Autism Spectrum Disorder Nonverbal Learning Disability Drug: Memantine Hydrochloride Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Memantine for the Treatment of Social Deficits in Youth With Disorders of Impaired Social Interactions: A Randomized-controlled Trial
Actual Study Start Date : November 13, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Memantine
Memantine administered in tablet form twice daily titrated to a maximum dose of 20 mg for 12 weeks.
Drug: Memantine Hydrochloride
Participating children and adolescents with Non-Verbal Learning Disorder and related conditions (NVLD-RC) who meet the eligibility criteria will be randomly assigned to memantine for the course of the 12-week randomized controlled trial (RCT).

Placebo Comparator: Placebo
Subjects in the placebo control group will receive a matched placebo pill with no active ingredients. This will be administered twice daily for 12 weeks.
Drug: Placebo
Participating children and adolescents with Non-Verbal Learning Disorder and related conditions (NVLD-RC) who meet the eligibility criteria will be randomly assigned to placebo for the course of the 12-week randomized controlled trial (RCT).




Primary Outcome Measures :
  1. Clinical Global Impression-Improvement Scale (CGI-I) [ Time Frame: Baseline to 12 weeks ]
    The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale (1 to 7-- with higher numbers indicating more severely affected) that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male & female subjects ages 8-18 years (inclusive).
  • Diagnostic Statistical Manual (DSM)-5 Autism Spectrum Disorder (ASD) diagnostic criteria as established by clinical diagnostic interview
  • At least moderate severity of social impairment as measured by a total raw score of ≥85 on the parent/guardian-completed Social Responsiveness Scale-Second Edition (SRS-2)14 and a score of ≥4 on the clinician-administered Clinical Global Impression-Severity scale (CGI-S)17.

Exclusion Criteria:

  • IQ ≤70 based on the Wechsler Abbreviated Scale of Intelligence-II (WASI-II) Vocabulary and Matrix Reasoning subtests
  • Impaired communicative speech
  • Subjects currently treated with the following medications (known to impact glutamate levels): Lamotrigine, Amantadine, N-acetylcysteine, D-cycloserine
  • Subjects treated with a psychotropic medication not listed above on a dose that has not been stable for at least 4 weeks prior to study baseline.
  • Co-administration of drugs that compete with memantine for renal elimination using the same renal cationic system, including hydrochlorothiazide, triamterene, metformin, cimetidine, ranitidine, quinidine, and nicotine
  • Initiation of a new psychosocial intervention within 30 days prior to randomization.
  • Subjects who are pregnant and/or nursing.
  • Subjects with a history of non-febrile seizures without a clear and resolved etiology.
  • Subjects with a history of or a current liver or kidney disease.
  • Clinically unstable psychiatric conditions or judged to be at serious suicidal risk.
  • Subjects who meet on the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS-E) for alcohol or drug dependence or abuse. If the subject has a recent history of substance abuse, there will be a two-week washout period before initiating the trial as an added precaution. There are no known safety issues relating to memantine and recent history of substance abuse.
  • 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).
  • Subjects with genitourinary conditions that raise urine pH (e.g., renal tubular acidosis, severe infection of the urinary tract).
  • Known hypersensitivity to memantine.
  • Severe allergies or multiple adverse drug reactions.
  • A history of intolerance or adequate exposure to memantine, as determined by the clinician.
  • Investigator and his/her immediate family defined as the investigator's spouse, parent, child, grandparent, or grandchild.

Information from the National Library of Medicine

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): NCT03553875


Contacts
Layout table for location contacts
Contact: Nina Dallenbach, BS 617-724-7079 ndallenbach@mgh.harvard.edu
Contact: Haley Driscoll, BA 617-724-2551 hdriscoll2@mgh.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Nina Dallenbach, BS    617-724-7079    ndallenbach@mgh.harvard.edu   
Contact: Haley Driscoll, BA    617-724-2551    hdriscoll2@mgh.harvard.edu   
Principal Investigator: Gagan Joshi, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Gagan Joshi, MD Massachusetts General Hospital

Layout table for additonal information
Responsible Party: Gagan Joshi, Director, Autism Spectrum Disorder Program in Pediatric Psychopharmacology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03553875     History of Changes
Other Study ID Numbers: 2018P001082
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gagan Joshi, Massachusetts General Hospital:
Autism
Massachusetts General Hospital
Additional relevant MeSH terms:
Layout table for MeSH terms
Learning Disorders
Autistic Disorder
Autism Spectrum Disorder
Social Communication Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents