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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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).
- 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.
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
|Contact: Nina Dallenbach, BSfirstname.lastname@example.org|
|Contact: Haley Driscoll, BAemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Nina Dallenbach, BS 617-724-7079 firstname.lastname@example.org|
|Contact: Haley Driscoll, BA 617-724-2551 email@example.com|
|Principal Investigator: Gagan Joshi, MD|
|Principal Investigator:||Gagan Joshi, MD||Massachusetts General Hospital|