Vibrant Capsule for Anorexia
Trial Summary
What is the purpose of this trial?
Anorexia nervosa (AN) has among the highest mortality rate of any psychiatric illness, yet we have a poor understanding of the biological causes of this disorder. In this study, we use a novel mechanosensory intervention to examine the basic question of whether individuals with AN have abnormal "gut sensations" and whether such indicators are associated with adverse consequences from the disorder.
Will I have to stop taking my current medications?
The trial requires that participants with anorexia nervosa must be on a stable dose of medication for at least one week before joining. However, if you are taking medications that affect intestinal movement or certain other medications, you may need to stop those to participate.
How does the Vibrant capsule treatment for anorexia differ from other treatments?
The Vibrant capsule treatment for anorexia is unique because it may involve a novel mechanism or administration route compared to traditional treatments like ghrelin, which is administered intravenously to stimulate appetite. While ghrelin increases hunger and food intake, the Vibrant capsule could offer a different approach, potentially involving oral administration or other innovative methods.12345
Eligibility Criteria
This trial is for females aged 15-40 with anorexia nervosa, a BMI ≥ 18.5, and stable on current medications. Participants must be able to walk, have a smartphone with data, speak English, use birth control if of childbearing age, and provide consent. Exclusions include psychiatric disorders other than AN, certain medication use (affecting gut motility), significant GI disorders or surgeries affecting the gut's structure/function.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo baseline assessments including interoceptive learning rate, precision, electrogastrogram, and evoked response potential measurements
Intervention
Participants receive either gastric stimulation via the Vibrant capsule or a placebo capsule
Follow-up
Participants are monitored for illness status including relapse, remission, or recovery at 1 month, 3 months, and 6 months
Treatment Details
Interventions
- Vibrant capsule
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Who Is Running the Clinical Trial?
Laureate Institute for Brain Research, Inc.
Lead Sponsor