Neurobiology of Bulimia Nervosa

NCT04225221 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 19-2343R21MH121726
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

bulimia nervosa; binge eating; eating disorder; estrogen

Outcome Measures

Primary Outcomes (10)

• Change in Binge Eating Sum Score

  Binge eating will be measured using the 8-item binge eating subscale of the Eating Pathology Symptoms Inventory (EPSI), which measures features of binge eating (e.g., consumption of large quantities of food, mindless eating) on a 5-point Likert scale from "never" to "very often." The EPSI scale is designed to assess behavior over the past 28 days; however, to be sensitive to the timeframe of the present study, the instructions will be modified to ask participants to consider the past week. Items are summed for a scale score ranging from 0-32. Higher scores indicate more frequent experiences with binge eating behavior. Change is defined by an average change score.

  Baseline (Day 14 of baseline) to End of Intervention (Day 14 of each intervention)

• Change in Weekly Average Binge-eating Frequency

  Binge eating frequency is based on a daily diary of self-reported binge eating frequency. Scores can range from 0 to infinity as they represent a self-reported frequency. Subjects self-report the number of binge eating episodes they had each day. Higher numbers indicate more frequent binge eating episodes. Average weekly frequency will be determined based on daily reported binge eating frequency. Change is defined by an average change score.

  Baseline (Day 14 of baseline) to End of Intervention (Day 14 of each intervention)

• Change in Self-Reported Reward Sensitivity Subscale Score During Estradiol Manipulation

  Sensitivity to Punishment/Sensitivity to Reward Questionnaire will be used to measure reward sensitivity during estradiol intervention. The reward sensitivity subscale will be used, which is rated on a true/false scale with scores ranging 0-24. Higher scores indicate more sensitivity to reward. Change is defined by an average change score.

  Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)

• Change in Response Latency to Reward During the Monetary Incentive Delay Task During Estradiol Manipulation

  Time (ms) between stimulus and response will be measured during the Monetary Incentive Delay (MID) task during the win trials during the estradiol intervention. During the MID task, participants need to select the correct response during "win" and "lose" conditions by pressing a button. Higher scores indicate a longer response time to the win trials. Change is defined by an average change score.

  Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)

• Change in Delay Discounting Parameter k Using the Monetary Choice Questionnaire With Estradiol Manipulation

  During the estradiol intervention, participants will be asked to make a series of hypothetical choices between small, sooner (impulsive) vs. larger, later (self controlled) hypothetical monetary outcomes. k is a hyperbolic function with larger k values indicating more valuation of a larger delayed reward and smaller values indicating preference for more immediate, smaller rewards (more impulsivity). Change is defined as the average change in k.

  Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)

• Change in Self-Reported Behavioral Inhibition Score During Estradiol Manipulation

  This measures assesses individual disposition toward avoidance of activities during the estradiol intervention. The Behavioural Inhibition subscale of the Behavioural Inhibition Scale/Behavioral Activation Scale (BIS/BAS) assesses behavioural inhibition (BI) using participant self-reports. The minimum score on the BIS subscale is 7, maximum 28. Greater scores indicate greater behavioural inhibition. Change is defined by an average change score

  Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)

• Change in Behavioral Activation Score During Estradiol Manipulation

  This measures assesses individual disposition toward engaging in activities during the estradiol intervention. Two BIS/BAS behavioural activation (BA) subscales will be used. The BA subscales used are Fun Seeking and Drive. Each subscale is summed to get the respective subscale scores. The minimum score on BA Fun Seeking and BA Drive are minimum 4 and maximum 16. Higher scores indicate greater behavioral activation. Change is defined by an average change score.

  Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)

• Change in Behavioral Activation Reward Responsiveness With Estradiol Manipulation

  This measures assesses individual disposition toward avoiding and engaging in activities during estradiol intervention. The BIS/BAS reward responsiveness subscale will be used. The minimum score on the BA Reward Responsiveness subscale is 5, maximum 20. Higher scores indicate greater reward responsiveness. Change is defined by an average change score.

  Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)

• Change in Behavioral Inhibition During Estradiol Administration as Assessed Through a Behavioral Task

  Behavioral response inhibition will be examined during a go/no-go computerized task during the estradiol intervention. Inhibitory control is defined by the response accuracy of the go no/go trials. Percent of errors is calculated as the number of "go" responses on a "no/go" trial" divided by the total number of "no/go" trials." Fewer errors ("go" response on a "no/go" trial) indicates better inhibitory control. Change is defined by an average change score.

  Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)

• Correlation Between Change in Reward Response and Change in Binge Eating Before and During Estradiol Manipulation

  Pearson correlations between change in self-reported reward response and change in binge eating between baseline and estradiol intervention will be examined. Binge eating is defined as the sum score from the Eating Pathology Symptom Inventory (EPSI). Self-reported reward response is defined as the BAS reward responsiveness subscale score and the Sensitivity to Reward/Sensitivity to Punishment Questionnaire (SPSRQ) sensitivity to reward subscale score. Change in binge eating and change in reward response between baseline and estradiol intervention was calculated and a correlation conducted between change scores.

  Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)

Study Arms (2)

Sequence A: estradiol followed by progesterone

EXPERIMENTAL

Participants are randomly assigned to treatment Sequence A: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence A will receive estradiol addback first, followed by progesterone. Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.

Drug: Estradiol; Drug: Micronized progesterone; Drug: Leuprolide Acetate; Drug: Placebo Oral Capsule

Sequence B: progesterone followed by estradiol

EXPERIMENTAL

Participants are randomly assigned to treatment Sequence B: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence B will receive progesterone first followed by estradiol. Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.

Drug: Estradiol; Drug: Micronized progesterone; Drug: Leuprolide Acetate; Drug: Placebo Oral Capsule

Interventions

Estradiol DRUG

During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.

Also known as: E2, Estrace

Sequence A: estradiol followed by progesterone; Sequence B: progesterone followed by estradiol

Micronized progesterone DRUG

During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.

Also known as: P4, Prometrium

Sequence A: estradiol followed by progesterone; Sequence B: progesterone followed by estradiol

Leuprolide Acetate DRUG

Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.

Also known as: Lupron Depot

Sequence A: estradiol followed by progesterone; Sequence B: progesterone followed by estradiol

Placebo Oral Capsule DRUG

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.

Also known as: Sugar pill

Sequence A: estradiol followed by progesterone; Sequence B: progesterone followed by estradiol

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: Men will not be included in this study given the stated purpose of studying the impact of ovarian hormones.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants will be women aged 18-42 with a current DSM-5 bulimia nervosa (BN) diagnosis who meet the below criteria. Only participants capable of giving informed consent and understanding the risks associated with the study will be enrolled.
• A regular menstrual cycle for at least three months
• \< 35 BMI \> 18.5
• Free of medication or medical condition that impacts ovarian hormones or is contraindicated for use with study interventions (including birth control pills)
• Speaks English

You may not qualify if:

• Patients will not be permitted to enter this protocol if they have any of the following:
• peanut allergy
• bipolar or psychotic disorder;
• current substance use disorder or frequent binge drinking behavior;
• frequent diuretic or laxative use, ipecac use;
• currently smoking \> 10 cigarettes daily;
• history of a suicide attempt or current suicidal ideation;
• endometriosis;
• abnormal genital/vaginal bleeding;
• undiagnosed enlargement of the ovaries;
• liver disease;
• breast cancer;
• personal history of blood clots (a history of blood clots in the legs or lungs; DVT); pregnancy related blood clots
• history of seizures or epilepsy;
• porphyria;

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (37)

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MeSH Terms

Conditions

Bulimia Nervosa; Bulimia; Feeding and Eating Disorders

Interventions

Estradiol; Progesterone; Leuprolide; Sugars

Condition Hierarchy (Ancestors)

Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Carbohydrates

Limitations and Caveats

Due to the COVID-19 pandemic, this trial was unable to enroll the number of participants needed to complete the study leading to only a very small number of participants.

Results Point of Contact

• Title: Jessica Baker, PhD
• Organization: University of North Carolina at Chapel Hill

jhbaker@med.unc.edu

984-235-0858

Study Officials

• Jessica Baker, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: February 24, 2020
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: July 26, 2022
• Results First Posted: July 26, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Deidentified individual data that supports the results will be shared beginning 18 to 24 months following publication.
• Access Criteria: Approval from an IRB, IEC, or REB, as applicable and execution of a data use/sharing agreement with UNC.

Locations

US (1)