Effect of Stimulant Medication on Loss of Control Eating in Youth With Attention Deficit/Hyperactivity Disorder

NCT05592119 | Completed

• 1 other identifier: 1028376
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Loss of control eating (LOC-E) in youth predicts the later development of full syndrome eating disorders, such as binge-eating disorder (BED), and therefore, could be a relevant target for prevention interventions. Children with attention deficit/hyperactivity disorder (ADHD) are at higher risk of experiencing LOC-E than healthy controls, and there is evidence that related neurocognitive predisposing factors, such as impulsivity and dysfunctional reward processing, are associated with the pathogenesis of LOC-E. Therefore, it is pertinent to examine whether modifying these neurocognitive symptoms influences LOC-E and the subsequent development of eating disorders. Stimulants are an efficacious treatment for impulsivity in youth with ADHD and have been shown to improve symptoms of binge eating in adults; however, studies have not prospectively explored the effect of stimulants on LOC-E in youth. To explore this gap, the investigators aim to collect prospective observational data in a clinical setting to measure change in LOC-E episodes and secondary outcomes in youth aged 8 to 13 years old with ADHD and LOC-E who are treated with stimulants. The investigators will collect outcome measures prior to stimulant initiation (baseline) and 3 months after stimulant initiation.

Conditions

Loss of Control Eating; Attention Deficit/Hyperactivity Disorder

Keywords

Stimulants; Eating disorders; Children; Binge eating

Outcome Measures

Primary Outcomes (1)

• Change in LOC-E episode frequency

  This will be measured using the Child Version of the Eating Disorder Examination (ChEDE C.1; Bryant-Waugh et al., 1996; Bryant-Waugh, 2020). The EDE 17.0D (Fairburn et al., 2014), which measures eating disorder symptom severity, has been modified for use with children ages 8 and above (Bryant-Waugh et al., 1996; Bryant-Waugh, 2020). The ChEDE has been shown to have high inter-rater reliability and internal consistency (Hilbert et al., 2013; Watkins et al., 2005). For the purposes of this study, only diagnostic item 11 (identifying bulimic episodes and other episodes of overeating) of the ChEDE will be used, which included questions regarding feelings of loss of control eating, features associated with binge eating, and distress about binge eating. The measure will be used for diagnostic assessment of LOC-E for study inclusion purposes, and at Baseline and 3-Month Follow-Up to establish LOC-E episode frequency.

  Screening, Baseline, 3 Months

Secondary Outcomes (6)

• Change in eating behaviour

  Baseline, 3 Months

• Change in disordered eating

  Baseline, 3 Months

• Change in ADHD symptom severity

  Baseline, 3 Months

• Change in Impulsivity and reward sensitivity

  Baseline, 3 Months

• Change in anxiety/mood severity

  Baseline, 3 Months

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Male and female youth aged 8 to 13 years old who are diagnosed with ADHD and LOC-E at the Atlantic ADHD Centre in Dartmouth, Nova Scotia.

You may qualify if:

• Youth 8 to 13 years of age
• Able to provide informed consent
• Meet DSM-V diagnostic criteria for ADHD
• Experienced at least 3 episodes of LOC-E during the past 3 months, accompanied by some degree of distress and 2 of the 5 behavioural symptoms associated with LOC-E

You may not qualify if:

• Currently receiving treatment for overweight
• Taking medication with effects on eating behaviour
• Insufficient English language skills

Sponsors & Collaborators

• Takeda: collaborator
• Nova Scotia Health Authority: lead

Study Sites (1)

Abbie J Lane Memorial Building - QEII

Halifax, Nova Scotia, B3H 2E2, Canada

Location

Related Publications (1)

• Keshen AR, Hilbert A, Taylor V, Harris AL, Trappenberg N, Sadek J, Frank GKW, Murray SB. Effect of stimulant medication on loss of control eating in youth with attention deficit/hyperactivity disorder: a prospective, observational case series study protocol. J Eat Disord. 2022 Nov 1;10(1):152. doi: 10.1186/s40337-022-00674-y.

  PMID: 36320022 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Feeding and Eating Disorders; Bulimia

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperphagia

Study Officials

• Aaron R Keshen, MD, FRCPC

  Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Aaron Keshen, MD, FRCPC

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 24, 2022
• Study Start: January 11, 2023
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

CA (1)