Trial · NCT01086475

D-Cycloserine and Social Skills Training in Autism Spectrum Disorders

NCT01086475, Phase 3, Completed, Indiana University; results first posted 2016-04-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. D-Cycloserine and Social Skills Training in Autism Spectrum Disorders. Trials, record NCT01086475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01086475

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Trial

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

Title: D-Cycloserine and Social Skills Training in Autism Spectrum Disorders
NCT number: NCT01086475
Status: Completed
Phases: Phase 3
Enrollment: 68 participants, actual
Lead sponsor: Indiana University
Conditions: Autistic Disorder, Asperger's Disorder, Pervasive Developmental Disorder NOS
Interventions: D-cycloserine, Placebo
First posted: 2010-03-15
Last updated: 2016-04-14
Results first posted: 2016-04-14

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Social Responsiveness Scale (SRS) Change	Completed at Baseline and Week 11	The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment
Primary	Social Responsiveness Scale (SRS) at Follow-Up	Completed at Week 22	The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment
Secondary	Clinical Global Impressions Improvement Scale Responder Analysis	Week 11	The CGI Global Improvement (CGI-I) is a clinician-rate scale designed to take into account all factors to arrive at an assessment of severity and response to treatment, including parent report, parent-rated measures, teacher-rated measures, and clinician-rated measures. The CGI-I is rated from 1 to 7 (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) at a single time-point. The CGI-I was completed at each visit, but only at week 11 were those subjects classified as "much" or "very much improved" defined as responders and all other classifications will be regarded as non-responders.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Social Responsiveness Scale (SRS) Change	Completed at Baseline and Week 11	Each group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.	units on a scale	MEAN
SECONDARY	Clinical Global Impressions Improvement Scale Responder Analysis	Week 11	Each social skills group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.	percentage of participants	NUMBER
PRIMARY	Social Responsiveness Scale (SRS) at Follow-Up	Completed at Week 22	Each group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Social Responsiveness Scale (SRS) Change	D-cycloserine	-13.39	Standard Deviation 16.81	units on a scale
Social Responsiveness Scale (SRS) Change	Placebo	-17.00	Standard Deviation 21.33	units on a scale
Clinical Global Impressions Improvement Scale Responder Analysis	D-cycloserine	32.3		percentage of participants
Clinical Global Impressions Improvement Scale Responder Analysis	Placebo	33.3		percentage of participants
Social Responsiveness Scale (SRS) at Follow-Up	D-cycloserine	83.5	Standard Deviation 2.3	units on a scale
Social Responsiveness Scale (SRS) at Follow-Up	Placebo	89.2	Standard Deviation 2.5	units on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	D-cycloserine	34
Overall Study	STARTED	Placebo	33
Overall Study	COMPLETED	D-cycloserine	34
Overall Study	COMPLETED	Placebo	33
Overall Study	NOT COMPLETED	D-cycloserine	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events24

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	Headache	General disorders	D-cycloserine	9	34	9
other	Headache	General disorders	Placebo	7	33	7
other	Nasal congestion or Cold	General disorders	D-cycloserine	6	34	6
other	Nasal congestion or Cold	General disorders	Placebo	8	33	8
other	Cough	General disorders	D-cycloserine	7	34	7
other	Cough	General disorders	Placebo	7	33	7
other	Vomiting	General disorders	D-cycloserine	6	34	6
other	Vomiting	General disorders	Placebo	2	33	2
other	Aggression	Psychiatric disorders	D-cycloserine	2	34	2
other	Aggression	Psychiatric disorders	Placebo	5	33	5

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	D-cycloserine
Total, all-cause mortality	Placebo
Total, other adverse events	D-cycloserine	32	34
Total, other adverse events	Placebo	28	33
Total, serious adverse events	D-cycloserine	0	34
Total, serious adverse events	Placebo	1	33

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26770664	DERIVED	PubMed
28138381	DERIVED	PubMed
33583058	DERIVED	PubMed
37811711	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
D-cycloserine vs Placebo: serious adverse events

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/NCT01086475

GET https://conductscience.org/api/trials/v1/NCT01086475/events?page=2

API reference For AI assistants