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NCT01086475 · ClinicalTrials.gov registry record · Phase 3

D-Cycloserine and Social Skills Training in Autism Spectrum Disorders

A Phase 3 study of Autistic Disorder and Asperger's Disorder, sponsored by Indiana University.

Completed
Registry status
Phase 3
Development phase
68
Enrollment target
2
Study locations

NCT01086475: Completed Phase 3 study of Autistic Disorder and Asperger's Disorder, sponsored by Indiana University.

NCT01086475 is a Phase 3 study of Autistic Disorder and Asperger's Disorder that has completed, run by Indiana University. The registered enrollment target is 68 participants, below the 111-participant average among 27 other Autistic Disorder trials with a reported enrollment target (39% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01086475, a Phase 3 study of Autistic Disorder and Asperger's Disorder, has completed, sponsored by Indiana University.

COMPLETED
Registry status
Phase 3
Development phase
68 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this study is to determine the effectiveness of D-cycloserine for improving social impairment in child with pervasive developmental disorders (PDD).

Primary Outcome

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

Interventions

  • DRUG Placebo
  • DRUG D-cycloserine

Study Locations (2)

Indiana

  • Riley Hospital for Children - Indianapolis

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2010-03
Est. Completion 2014-01
Phase Phase 3
Indiana University

890 total trials

What the finished NCT01086475 record still lists

NCT01086475 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 111-participant average among 27 other Autistic Disorder trials with a reported enrollment target (39% lower).

The record links to 3 conditions, with Autistic Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01086475 reports a single indexed study location in Indiana, Ohio.

Frequently Asked Questions

What is clinical trial NCT01086475 about?

NCT01086475 is a clinical study titled "D-Cycloserine and Social Skills Training in Autism Spectrum Disorders". The purpose of this study is to determine the effectiveness of D-cycloserine for improving social impairment in child with pervasive developmental disorders (PDD).

What is the current status of trial NCT01086475?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 68 participants. The study started on 2010-03. Estimated completion is 2014-01.

What conditions does trial NCT01086475 study?

This clinical trial studies the following conditions: Autistic Disorder, Asperger's Disorder, Pervasive Developmental Disorder NOS.

What interventions are being tested in trial NCT01086475?

The interventions under investigation include: Placebo (DRUG), D-cycloserine (DRUG).

Who is sponsoring clinical trial NCT01086475?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01086475 being conducted?

This trial has 2 study locations across Indiana, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Autistic Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01086475's enrollment target sits among peer trials

68 14th of 27 higher than 14 of 27 other Autistic Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Autistic Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01086475, the US trial registry maintained by the National Library of Medicine. NCT01086475 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.