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

Autism Spectrum Disorder Clinical Trial

Official title:

Memantine for the Treatment of Social Deficits in Youth With Disorders of Impaired Social Interactions: A Randomized-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03553875
• Other study ID #: 2018P001082
• Status: Recruiting
• Phase: Phase 3
• Start date: November 13, 2018
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: Massachusetts General Hospital
• Contact: Chloe Hutt Vater, BA
• Phone: 617-724-7301
• Email: chuttvater[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Learning Disabilities
• Nonverbal Learning Disability

Intervention

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
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).

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression-Improvement Scale (CGI-I)	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.	Baseline to 12 weeks