NCT03497988

Intranasal Oxytocin and Food Intake in Obese Adolescents

Effect of a Single Dose of Intranasal Oxytocin on Food Intake in Obese Adolescents

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shana McCormack, MD · Academic / Other
• Sex: All
• Age: 13 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the effect of intranasal OXT caloric intake and eating behaviors in otherwise healthy obese adolescents. The primary objective of this study is to determine the effects of intranasal administration of oxytocin on food intake in obese, pubertal or post-pubertal adolescents (13 to \<18 years in girls, and 15 to \<20 years in boys).

Detailed description

Participants will undergo a telephone screening and then, within 4 weeks, complete an in-person screening visit to determine eligibility. Then, within 4 weeks they will be randomized to either OXT or placebo. After a minimum 1-week (7-28 days) "washout," participants will cross-over to treatment with the other condition (i.e., placebo or OXT).

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Syntocinon	The active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin.
DRUG	Placebo	The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin.

Timeline

• Start date: 2018-09-01
• Primary completion: 2020-06-01
• Completion: 2021-06-01
• First posted: 2018-04-13
• Last updated: 2018-12-26

Regulatory

• FDA-regulated drug study