D-cycloserine and Treatment of Feeding Disorders
Use of D-cycloserine to Facilitate Extinction of Food Aversion in Pediatric Populations
2 other identifiers
interventional
16
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2013
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2012
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedFirst Posted
Study publicly available on registry
August 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
October 23, 2014
CompletedOctober 23, 2014
October 1, 2014
6 months
September 18, 2012
October 17, 2014
October 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Rapid Swallowing
Rapid swallowing was scored if the child swallowed the entire bolus within 30 seconds after the feeder deposited the bite. This was visually confirmed by the feeder using a three-step prompting sequence (i.e., verbal: ''show me''; gestural: ''show me like this'' plus modeling opening the mouth; physical: ''show me'' plus gentle pressure applied to the side of the teeth with a baby spoon).
Mealtime behavior (swallowing) at meal 1
Rapid Swallowing
Rapid swallowing was scored if the child swallowed the entire bolus within 30 seconds after the feeder deposited the bite. This was visually confirmed by the feeder using a three-step prompting sequence (i.e., verbal: ''show me''; gestural: ''show me like this'' plus modeling opening the mouth; physical: ''show me'' plus gentle pressure applied to the side of the teeth with a baby spoon).
Mealtime behavior (swallowing) at meal 13
Disruptions
Disruptions were defined as turning the head 45 degrees away from the spoon and/or pushing away the spoon or feeder's hand/arm during the bite presentation. Converted counts of each variable into percentages by dividing the total occurrence of a target behavior during a meal by the total number of bites presented per meal
Mealtime behavior (disruptions) at meal 1
Disruptions
Disruptions were defined as turning the head 45 degrees away from the spoon and/or pushing away the spoon or feeder's hand/arm during the bite presentation. Converted counts of each variable into percentages by dividing the total occurrence of a target behavior during a meal by the total number of bites presented per meal
Mealtime behavior (disruptions) at meal 13
Study Arms (2)
Behavioral Intervention & DCS
EXPERIMENTALBehavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day
Behavioral Intervention & Placebo
ACTIVE COMPARATORBehavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube)
Interventions
Behavioral intervention targeting severe feeding disorders involves the combination of escape extinction and antecedent manipulation of food presentation to lessen the aversive quality of the meal. This allows treatment to address the consequences maintaining food refusal in the least restrictive environment while ameliorating possible side effects associated with extinction procedures.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (1)
Marcus Autism Center - Children's Healthcare of Atlanta
Atlanta, Georgia, 30329, United States
Related Publications (3)
Sharp WG, Jaquess DL, Morton JF, Herzinger CV. Pediatric feeding disorders: a quantitative synthesis of treatment outcomes. Clin Child Fam Psychol Rev. 2010 Dec;13(4):348-65. doi: 10.1007/s10567-010-0079-7.
PMID: 20844951BACKGROUNDNorberg MM, Krystal JH, Tolin DF. A meta-analysis of D-cycloserine and the facilitation of fear extinction and exposure therapy. Biol Psychiatry. 2008 Jun 15;63(12):1118-26. doi: 10.1016/j.biopsych.2008.01.012. Epub 2008 Mar 7.
PMID: 18313643BACKGROUNDRessler KJ, Rothbaum BO, Tannenbaum L, Anderson P, Graap K, Zimand E, Hodges L, Davis M. Cognitive enhancers as adjuncts to psychotherapy: use of D-cycloserine in phobic individuals to facilitate extinction of fear. Arch Gen Psychiatry. 2004 Nov;61(11):1136-44. doi: 10.1001/archpsyc.61.11.1136.
PMID: 15520361BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The sample size was small and analyses were underpowered to detect group differences.
Results Point of Contact
- Title
- William G. Sharp Ph.D.
- Organization
- Emory University
Study Officials
- PRINCIPAL INVESTIGATOR
William G Sharp, Ph.D.
Emory University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 18, 2012
First Posted
August 16, 2013
Study Start
March 1, 2013
Primary Completion
September 1, 2013
Study Completion
November 1, 2013
Last Updated
October 23, 2014
Results First Posted
October 23, 2014
Record last verified: 2014-10