Phase 2
N=10
Neurobiology of Bulimia Nervosa
Bulimia Nervosa
Bottom Line
View on ClinicalTrials.gov: NCT04225221 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Change in Binge Eating Sum Score — -0.60; 0.89 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Estradiol (Drug); Micronized progesterone (Drug); Leuprolide Acetate (Drug); Placebo Oral Capsule (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Binge Eating Sum Score |
-0.60; 0.89 | — |
| PRIMARY Change in Weekly Average Binge-eating Frequency |
-0.48; 1.1 | — |
| PRIMARY Change in Self-Reported Reward Sensitivity Subscale Score During Estradiol Manipulation |
-0.80 | — |
| PRIMARY Change in Response Latency to Reward During the Monetary Incentive Delay Task During Estradiol Manipulation |
-9.0 | — |
| PRIMARY Change in Delay Discounting Parameter k Using the Monetary Choice Questionnaire With Estradiol Manipulation |
-0.0047 | — |
| PRIMARY Change in Self-Reported Behavioral Inhibition Score During Estradiol Manipulation |
0.90 | — |
| PRIMARY Change in Behavioral Activation Score During Estradiol Manipulation |
-0.10; 0 | — |
| PRIMARY Change in Behavioral Activation Reward Responsiveness With Estradiol Manipulation |
0.10 | — |
| PRIMARY Change in Behavioral Inhibition During Estradiol Administration as Assessed Through a Behavioral Task |
-0.094 | — |
| PRIMARY Correlation Between Change in Reward Response and Change in Binge Eating Before and During Estradiol Manipulation |
-0.146; -0.132 | — |
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.
Eligibility Criteria
Inclusion Criteria
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
- 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
Exclusion Criteria
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;
- diabetes mellitus;
- malignant melanoma;
- gallbladder or pancreatic disease;
- heart or kidney disease;
- cerebrovascular disease (stroke);
- history of osteoporosis or osteopenia;
- recurrent migraine with aura;
- first degree relative (immediate family) with premenopausal breast cancer or breast cancer presenting in both breasts or any woman who has multiple family members (greater than three relatives) with postmenopausal breast cancer will also be excluded from participating in this protocol;
- Refusal to use non-hormonal contraception throughout study;
- Pregnant women will be excluded from participation (patients will be warned not to become pregnant during the study and will be advised to employ barrier contraceptive methods), and women who become pregnant (although unlikely because of the hormone manipulation) will be withdrawn;
- Any condition or symptoms considered by the study team to detrimentally impact subject safety.
Data sourced from ClinicalTrials.gov (NCT04225221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.