Trial · NCT01972074

Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder

NCT01972074, Phase 3, Completed, Massachusetts General Hospital; results first posted 2019-09-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder. Trials, record NCT01972074. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01972074

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder
NCT number: NCT01972074
Status: Completed
Phases: Phase 3
Enrollment: 84 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Autism Spectrum Disorder
Interventions: Memantine, Placebo
First posted: 2013-10-30
Last updated: 2024-07-01
Results first posted: 2019-09-11

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Treatment Responder	12 Weeks (from Baseline [Week 0] to Endpoint [Week 12])	Treatment responders are defined as having a 25% reduction, from baseline to endpoint, in Social Responsiveness Scale, Second Edition: School-Age, Parent Report (SRS-2) total raw score and an Autism Spectrum Disorder Clinical Global Impression-Improvement (ASD CGI-I) score ≤2. The Social Responsiveness Scale, Second Edition (SRS-2) is a 65-item rating scale completed by the parents/guardians of children ages 4-18. It is used to measure the severity of autism spectrum disorder symptoms. Each item is rated on a 4-point Likert scale, ranging from 1=Not True to 4=Almost Always True. Higher scores indicate a higher severity of autism spectrum disorder symptoms. The Autism Spectrum Disorder Clinical Global Impression-Improvement subscale (ASD CGI-I) is a clinician-rated measure of the improvement of autism spectrum disorder symptoms. The subscale is rated on a 7-point Likert scale, ranging from 1=Very Much Improved to 7=Very Much Worse. Higher scores indicate less symptom improvement.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Treatment Responder	12 Weeks (from Baseline [Week 0] to Endpoint [Week 12])	Participants included in this analysis were exposed to study medication for at least 2 weeks. Participants in the Control Group were excluded from this analysis because they did not receive study medication and, therefore, cannot be categorized into Treatment Responders vs. Treatment Non-Responders.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Treatment Responder	Memantine		9		Participants
Treatment Responder	Placebo		4		Participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Memantine	22
Overall Study	STARTED	Placebo	21
Overall Study	STARTED	Control Group	18
Overall Study	COMPLETED	Memantine	16
Overall Study	COMPLETED	Placebo	17
Overall Study	COMPLETED	Control Group	15
Overall Study	NOT COMPLETED	Memantine	6
Overall Study	NOT COMPLETED	Placebo	4
Overall Study	NOT COMPLETED	Control Group	3

Source ClinicalTrials.gov

Adverse events57

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal Discomfort	Gastrointestinal disorders	Memantine	2	22	2
other	Abdominal Discomfort	Gastrointestinal disorders	Placebo	1	21	1
other	Abdominal Discomfort	Gastrointestinal disorders	Control Group	0	0	0
other	Anxious/Worried	Psychiatric disorders	Memantine	2	22	2
other	Anxious/Worried	Psychiatric disorders	Placebo	2	21	2
other	Anxious/Worried	Psychiatric disorders	Control Group	0	0	0
other	Cold/Infection/Allergy	Respiratory, thoracic and mediastinal disorders	Memantine	3	22	3
other	Cold/Infection/Allergy	Respiratory, thoracic and mediastinal disorders	Placebo	1	21	1
other	Cold/Infection/Allergy	Respiratory, thoracic and mediastinal disorders	Control Group	0	0	0
other	Constipation	Gastrointestinal disorders	Memantine	0	22	0

1 to 10 of 57Source ClinicalTrials.gov

See all 57 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Memantine	0	22
Total, all-cause mortality	Placebo	0	21
Total, all-cause mortality	Control Group	0	0
Total, other adverse events	Memantine	14	22
Total, other adverse events	Placebo	9	21
Total, other adverse events	Control Group	0	0
Total, serious adverse events	Memantine	0	22
Total, serious adverse events	Placebo	0	21
Total, serious adverse events	Control Group	0	0

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36006807	DERIVED	PubMed
37811711	DERIVED	PubMed
41032298	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Memantine vs Placebo: Treatment Responder

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01972074

GET https://conductscience.org/api/trials/v1/NCT01972074/events?page=2

API reference For AI assistants