Neurobiology of Bulimia Nervosa

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.

Conditions

• Bulimia Nervosa

Interventions

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Jessica Baker, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

42 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-24

Primary Completion

2022-04-04

Completion

2022-04-04

FDA Drug

Yes

Countries

• United States

Study Locations