NCT04225221

Neurobiology of Bulimia Nervosa

Ovarian Hormones, Reward Response, and Binge Eating in Bulimia Nervosa: An Experimental Design

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Not accepted

Summary

This pilot study experimentally manipulates ovarian hormones to examine the direct impact of estrogen (E2) and progesterone (P4) on binge eating symptom burden and the behavioral reward response in women with bulimia nervosa (n=15). This is completed by taking medications that change ovarian hormone levels. This line of research could lead to the development of pharmacological interventions developed to target specific areas of the brain, brain receptors, or pathways identified to be involved in the mechanism underlying ovarian hormone change and binge eating.

Detailed description

Eating disorders (EDs) affect 15 million women in the United States and have one of the highest mortality rates of any mental illness. Despite this, the underlying neurobiology remains poorly understood. EDs predominantly occur in women, and the frequency of certain symptoms change in a predictable pattern over the menstrual cycle; specifically, symptom changes appear to be triggered by normal fluctuations in the ovarian hormones estradiol (E2) and progesterone (P4). The objective of this study is to examine the direct and mechanistic role of E2 and P4 on binge eating in women with bulimia nervosa (BN; n = 15). The experimental design parallels an established design developed to determine the hormonal triggers of premenstrual dysphoric disorder and depression: temporarily stopping the menstrual cycle using a Gonadotropin-releasing hormone (GnRH) agonist (Lupron) and addback E2 and P4 independently in a double-blind crossover design. The overarching hypothesis is that BN represents a hormone-sensitive phenotype, and this sensitivity is modulated by E2's effects on aspects of the reward response such that reward-motivated behaviors increase in the context of low E2. This line of research will provide direction for future research addressing neuroendocrine, neurobiological, and brain activity and function in BN. To date, there are no medications that have been developed specifically for the treatment of individuals with BN. Our specific aims are to: Aim 1: Quantify the direct effect of E2 and P4 on binge eating in women with BN. Aim 2: Determine the effect of E2 on reward response in women with BN. Aim 3: Examine the association between reward response and binge eating before and after E2 addback.

Conditions

• Bulimia Nervosa

Interventions

Type	Name	Description
DRUG	Estradiol	During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
DRUG	Micronized progesterone	During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
DRUG	Leuprolide Acetate	Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
DRUG	Placebo Oral Capsule	Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.

Timeline

• Start date: 2020-02-24
• Primary completion: 2022-04-04
• Completion: 2022-04-04
• First posted: 2020-01-13
• Last updated: 2022-07-26
• Results posted: 2022-07-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study