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

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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

Tracking Information
First Submitted Date  ICMJE June 1, 2018
First Posted Date  ICMJE June 12, 2018
Last Update Posted Date November 20, 2019
Actual Study Start Date  ICMJE November 13, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2018)
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 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.
Change History Complete list of historical versions of study NCT03553875 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Memantine for the Treatment of Social Deficits in Youth With Disorders of Impaired Social Interactions
Official Title  ICMJE Memantine for the Treatment of Social Deficits in Youth With Disorders of Impaired Social Interactions: A Randomized-controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Autism
  • Autism Spectrum Disorder
  • Nonverbal Learning Disability
Intervention  ICMJE
  • 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).
  • 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).
Study Arms  ICMJE
  • Active Comparator: Memantine
    Memantine administered in tablet form twice daily titrated to a maximum dose of 20 mg for 12 weeks.
    Intervention: Drug: Memantine Hydrochloride
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 1, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nina Dallenbach, BS 617-724-7079 ndallenbach@mgh.harvard.edu
Contact: Haley Driscoll, BA 617-724-2551 hdriscoll2@mgh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03553875
Other Study ID Numbers  ICMJE 2018P001082
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gagan Joshi, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gagan Joshi, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP