D-cycloserine and Treatment of Feeding Disorders
Public ClinicalTrials.gov record NCT01923896. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Use of D-cycloserine to Facilitate Extinction of Food Aversion in Pediatric Populations
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The proposed study represents the first attempt to systematically investigate the use of DCS as an adjunct to behavioral intervention to address chronic food aversion through an randomized control drug trial in children treated at the Marcus Autism Center's Pediatrics Feeding Disorders Program. This pilot and feasibility study will involve a total of 16 participants randomly assigned to experimental conditions: behavioral intervention or behavioral intervention + DCS (8 in each group). All participants will receive the same behavioral protocol involving three treatment sessions per day (45 minutes in length), for a total of 15 sessions across five consecutive days. In addition, participants in the behavioral intervention + DCS group will receive a low dose (0.7 mg/kg) of the drug using an acute dosing methodology, which has been demonstrated to produce a nearly negligible side effect profile with comparable treatment outcomes to chronic dosing. Timing of dosing will occur 1 hour prior to behavioral intervention, in line with prior clinical studies. Study staff, with consultation from a psychiatrist, will observe administration of DCS to participants by caregivers via their preferred method of formula consumption (bottle, cup, or tube) in liquid form. Participants will be evaluated during each treatment session and at follow-up using trained observers to collect data on mealtime behaviors, including acceptance, swallowing, disruption, expulsion, and grams consumed. This type of data collection is standard practice in the feeding disorders program. It is hypothesized that participants who receive DCS as an adjunct to behavioral intervention will show greater improvement in mealtime behaviors as reflected by these measures.
Study identification
- NCT ID
- NCT01923896
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 16 participants
Conditions and interventions
Conditions
Interventions
- Behavioral Intervention Behavioral
- d-cycloserine (DCS) Drug
- Placebo Drug
Behavioral · Drug
Eligibility (public fields only)
- Age range
- 18 Months to 6 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2013
- Primary completion
- Aug 31, 2013
- Completion
- Oct 31, 2013
- Last update posted
- Oct 22, 2014
2013
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Marcus Autism Center - Children's Healthcare of Atlanta | Atlanta | Georgia | 30329 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01923896, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 22, 2014 · Synced Sep 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01923896 live on ClinicalTrials.gov.