D-cycloserine and Treatment of Feeding Disorders

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Feeding Disorders, Specific Phobia

In brief

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.

Key facts

Study ID

NCT01923896

Run by

Emory University

People needed

16

Starts

2013-03-01

Expected to finish

2013-11-01

Last updated by the study team

2014-10-23

Who can join

Age: 2 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Present with partial food refusal as evidenced by greater than 50% of caloric needs met by bottle, formula, or tube feedings, thus eliminating children whose lack of consumption is related to a skill deficit
• Have a medical history significant for an organic factor (e.g., gastrointestinal issues) which precipitated or played a role in the development of feeding concerns, thus capturing children whose food aversion mimics animal and human models of anxiety and aversion
• Between the ages of 18 months and 6 years
• Live within 2 hours of the Feeding Disorders Program at Marcus Autism Center to increase retention and maximize attendance
• English speaking

You may not qualify if…

• Patients with previous behavioral treatment for feeding disorder
• Patients with active medical conditions requiring ongoing hospitalization
• Patients unwilling to take study medication

Where it is running

• Marcus Autism Center - Children's Healthcare of Atlanta — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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