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NCT03557684 · ClinicalTrials.gov registry record · Early Phase 1
Leucine for Depression Study (L-DEP)
A Early Phase 1 study, sponsored by University of California, Los Angeles.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 59
- Enrollment target
NCT03557684 is a Early Phase 1 study that was terminated before completion, run by University of California, Los Angeles. The registered enrollment target is 59 participants.
The verdict
NCT03557684, a Early Phase 1 study, was terminated before completion, sponsored by University of California, Los Angeles.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 59 participants
- Enrollment target
Study Summary
Depression is very common and poses a huge disease burden. About 20% of the US population suffers from depression at lease once in their lifetime. Inflammations that are hidden inside our body as a result of aging, obesity, chronic diseases, or certain treatments (e.g., interferon for hepatitis C) appear to cause depressive symptoms and even clinical depression. Individuals with such inflammations are more likely to suffer from depression and are less likely to respond to currently available antidepressant medications. This study will test leucine, an amino acid, as a new way to mitigate depressive symptoms in response to such inflammations. This study begins with a 90-minute screening session to determine whether participants are eligible to join the main study. Those who meet the eligibility criteria will then join the main study, which will consist of taking leucine or maltodextrin (i.e., oral placebo) for 2 weeks at home and an 8-hour session at the UCLA Medical Center. A brief telephone follow-up every 3 months for 2 years with questions on mood is also planned. Approximately 90 healthy adults will be recruited for participation in the study. During the course of the study, participants will take leucine or maltodextrin for 2 weeks at home and then will be injected either lipopolysaccharide (LPS) or saline (i.e., intravenous placebo) at the UCLA Medical Center. LPS is a bacterial substance that can initiate chemical reactions that are similar to those seen in individuals with mild sickness symptoms, such as a slight increase in body temperature, muscle aches, or tiredness. It is a safe way of investigating the body's response to inflammation and how these changes may alter cognitive, emotional, or neural function. It has been given thousands of times to healthy volunteers - both younger and older adults - without any serious side effects.
Interventions
- OTHER IV placebo
- DIETARY_SUPPLEMENT leucine
- OTHER PO placebo
- BIOLOGICAL lipopolysaccharide (LPS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2018-09-01 |
| Est. Completion | 2021-07-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03557684
The ClinicalTrials.gov registry entry for NCT03557684 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which IV placebo is the first listed.
NCT03557684 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03557684 about?
NCT03557684 is a clinical study titled "Leucine for Depression Study (L-DEP)". Depression is very common and poses a huge disease burden. About 20% of the US population suffers from depression at lease once in their lifetime. Inflammations that are hidden inside our body as a result of aging, obesity, chronic diseases, or certain treatments (e.g., interferon for hepatitis C) a...
What is the current status of trial NCT03557684?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 59 participants. The study started on 2018-09-01. Estimated completion is 2021-07-31.
What interventions are being tested in trial NCT03557684?
The interventions under investigation include: IV placebo (OTHER), leucine (DIETARY_SUPPLEMENT), PO placebo (OTHER), lipopolysaccharide (LPS) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03557684?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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