Trial · NCT04225221

Neurobiology of Bulimia Nervosa

NCT04225221, Phase 2, Completed, University of North Carolina, Chapel Hill; results first posted 2022-07-26

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Neurobiology of Bulimia Nervosa. Trials, record NCT04225221. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04225221

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Neurobiology of Bulimia Nervosa
NCT number: NCT04225221
Status: Completed
Phases: Phase 2
Enrollment: 10 participants, actual
Lead sponsor: University of North Carolina, Chapel Hill
Conditions: Bulimia Nervosa
Interventions: Estradiol, Micronized progesterone, Leuprolide Acetate, Placebo Oral Capsule
First posted: 2020-01-13
Last updated: 2022-07-26
Results first posted: 2022-07-26
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.

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Binge Eating Sum Score	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of each intervention)	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.
Primary	Change in Weekly Average Binge-eating Frequency	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of each intervention)	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.
Primary	Change in Self-Reported Reward Sensitivity Subscale Score During Estradiol Manipulation	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)	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.
Primary	Change in Response Latency to Reward During the Monetary Incentive Delay Task During Estradiol Manipulation	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)	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.
Primary	Change in Delay Discounting Parameter k Using the Monetary Choice Questionnaire With Estradiol Manipulation	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)	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.
Primary	Change in Self-Reported Behavioral Inhibition Score During Estradiol Manipulation	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)	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
Primary	Change in Behavioral Activation Score During Estradiol Manipulation	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)	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.
Primary	Change in Behavioral Activation Reward Responsiveness With Estradiol Manipulation	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)	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.
Primary	Change in Behavioral Inhibition During Estradiol Administration as Assessed Through a Behavioral Task	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)	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.
Primary	Correlation Between Change in Reward Response and Change in Binge Eating Before and During Estradiol Manipulation	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)	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.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Binge Eating Sum Score	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of each intervention)		score on a scale	MEAN
PRIMARY	Change in Weekly Average Binge-eating Frequency	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of each intervention)		episodes/week	MEAN
PRIMARY	Change in Self-Reported Reward Sensitivity Subscale Score During Estradiol Manipulation	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)		score on a scale	MEAN
PRIMARY	Change in Response Latency to Reward During the Monetary Incentive Delay Task During Estradiol Manipulation	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)		ms	MEAN
PRIMARY	Change in Delay Discounting Parameter k Using the Monetary Choice Questionnaire With Estradiol Manipulation	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)		k value	MEAN
PRIMARY	Change in Self-Reported Behavioral Inhibition Score During Estradiol Manipulation	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)		score on a scale	MEAN
PRIMARY	Change in Behavioral Activation Score During Estradiol Manipulation	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)		score on a scale	MEAN
PRIMARY	Change in Behavioral Activation Reward Responsiveness With Estradiol Manipulation	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)		score on a scale	MEAN
PRIMARY	Change in Behavioral Inhibition During Estradiol Administration as Assessed Through a Behavioral Task	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)	Data unavailable as task was not completed by one participant.	percentage of errors	MEAN
PRIMARY	Correlation Between Change in Reward Response and Change in Binge Eating Before and During Estradiol Manipulation	Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)		Pearson correlation coefficient	NUMBER

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Binge Eating Sum Score	Estradiol		-0.60	Standard Deviation 4.7	score on a scale
Change in Binge Eating Sum Score	Progesterone		0.89	Standard Deviation 4.7	score on a scale
Change in Weekly Average Binge-eating Frequency	Estradiol		-0.48	Standard Deviation 2.6	episodes/week
Change in Weekly Average Binge-eating Frequency	Progesterone		1.1	Standard Deviation 4.7	episodes/week
Change in Self-Reported Reward Sensitivity Subscale Score During Estradiol Manipulation	Estradiol		-0.80	Standard Deviation 1.9	score on a scale
Change in Response Latency to Reward During the Monetary Incentive Delay Task During Estradiol Manipulation	Estradiol		-9.0	Standard Deviation 44.0	ms
Change in Delay Discounting Parameter k Using the Monetary Choice Questionnaire With Estradiol Manipulation	Estradiol		-0.0047	Standard Deviation 0.011	k value
Change in Self-Reported Behavioral Inhibition Score During Estradiol Manipulation	Estradiol		0.90	Standard Deviation 1.8	score on a scale
Change in Behavioral Activation Score During Estradiol Manipulation	Estradiol	Fun Seeking	-0.10	Standard Deviation 0.88	score on a scale
Change in Behavioral Activation Score During Estradiol Manipulation	Estradiol	Drive	0	Standard Deviation 1.4	score on a scale

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Lupron and Placebo Baseline (6 Weeks)	STARTED	Sequence A: Estradiol Followed by Progesterone	6
Lupron and Placebo Baseline (6 Weeks)	STARTED	Sequence B: Progesterone Followed by Estradiol	4
Lupron and Placebo Baseline (6 Weeks)	COMPLETED	Sequence A: Estradiol Followed by Progesterone	5
Lupron and Placebo Baseline (6 Weeks)	COMPLETED	Sequence B: Progesterone Followed by Estradiol	4
Lupron and Placebo Baseline (6 Weeks)	NOT COMPLETED	Sequence A: Estradiol Followed by Progesterone	1
Lupron and Placebo Baseline (6 Weeks)	NOT COMPLETED	Sequence B: Progesterone Followed by Estradiol	0
First Intervention (2 Weeks)	STARTED	Sequence A: Estradiol Followed by Progesterone	6
First Intervention (2 Weeks)	STARTED	Sequence B: Progesterone Followed by Estradiol	4
First Intervention (2 Weeks)	COMPLETED	Sequence A: Estradiol Followed by Progesterone	6
First Intervention (2 Weeks)	COMPLETED	Sequence B: Progesterone Followed by Estradiol	4

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events57

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Localized rash at injection site	Skin and subcutaneous tissue disorders	Estradiol	0	10	0
other	Localized rash at injection site	Skin and subcutaneous tissue disorders	Progesterone	0	9	0
other	Localized rash at injection site	Skin and subcutaneous tissue disorders	Lupron and Placebo	1	10	1
other	Diarrhea	Gastrointestinal disorders	Estradiol	0	10	0
other	Diarrhea	Gastrointestinal disorders	Progesterone	0	9	0
other	Diarrhea	Gastrointestinal disorders	Lupron and Placebo	1	10	1
other	Bloating	Gastrointestinal disorders	Estradiol	1	10	1
other	Bloating	Gastrointestinal disorders	Progesterone	0	9	0
other	Bloating	Gastrointestinal disorders	Lupron and Placebo	3	10	3
other	Headache	Nervous system disorders	Estradiol	0	10	0

1 to 10 of 57Source ClinicalTrials.gov

See all 57 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Estradiol	0	10
Total, all-cause mortality	Progesterone	0	9
Total, all-cause mortality	Lupron and Placebo	0	10
Total, other adverse events	Estradiol	5	10
Total, other adverse events	Progesterone	7	9
Total, other adverse events	Lupron and Placebo	10	10
Total, serious adverse events	Estradiol	0	10
Total, serious adverse events	Progesterone	0	9
Total, serious adverse events	Lupron and Placebo	0	10

Source ClinicalTrials.gov

Papers37

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
1870648	BACKGROUND	PubMed
2394784	BACKGROUND	PubMed
3438453	BACKGROUND	PubMed
8267060	BACKGROUND	PubMed
9238064	BACKGROUND	PubMed
9435325	BACKGROUND	PubMed
10438404	BACKGROUND	PubMed
10593380	BACKGROUND	PubMed
10831472	BACKGROUND	PubMed
10875899	BACKGROUND	PubMed

1 to 10 of 37

See all 37 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R21MH121726	Ovarian Hormones, Reward Response, and Binge Eating in Bulimia Nervosa: An Experimental Design	BAKER, JESSICA H	UNIV OF NORTH CAROLINA CHAPEL HILL	NATIONAL INSTITUTE OF MENTAL HEALTH	2019 to 2020

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests3

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Delay Discounting	Primary outcome	ConductCognition
Go/No-Go Task	Primary outcome	ConductCognition
Monetary Incentive Delay	Primary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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