Leucine for Depression Study (L-DEP)

NCT ID: NCT03557684

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2021-07-31

Brief 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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

PO leucine & IV LPS

Oral (PO) leucine 6 g twice a day for 2 weeks followed by a single intravenous (IV) bolus of lipopolysaccharide (LPS) 0.8 ng/kg of body weight

Group Type: EXPERIMENTAL

leucine

Intervention Type: DIETARY_SUPPLEMENT

amino acid leucine in powder

lipopolysaccharide (LPS)

Intervention Type: BIOLOGICAL

purified bacterial wall component as an inflammatory challenge

PO placebo & IV LPS

PO maltodextrin (placebo) twice a day for 2 weeks followed by a single IV bolus of LPS 0.8 ng/kg of body weight

Group Type: EXPERIMENTAL

PO placebo

Intervention Type: OTHER

maltodextrin

lipopolysaccharide (LPS)

Intervention Type: BIOLOGICAL

purified bacterial wall component as an inflammatory challenge

PO leucine & IV placebo

PO leucine 6 g twice a day for 2 weeks followed by a single IV bolus of 0.9% saline

Group Type: EXPERIMENTAL

leucine

Intervention Type: DIETARY_SUPPLEMENT

amino acid leucine in powder

IV placebo

Intervention Type: OTHER

0.9% saline

PO placebo & IV placebo

PO maltodextrin (placebo) twice a day for 2 weeks followed by a single IV bolus of 0.9% saline

Group Type: PLACEBO_COMPARATOR

PO placebo

Intervention Type: OTHER

maltodextrin

IV placebo

Intervention Type: OTHER

0.9% saline

Interventions

leucine

amino acid leucine in powder

Intervention Type: DIETARY_SUPPLEMENT

PO placebo

maltodextrin

Intervention Type: OTHER

lipopolysaccharide (LPS)

purified bacterial wall component as an inflammatory challenge

Intervention Type: BIOLOGICAL

IV placebo

0.9% saline

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Participants will be required to be in good general health (as evaluated during the phone and in-person screening sessions) and aged 18 to 65 years.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Joshua Hyong-Jin Cho

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joshua H Cho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California Los Angeles David Geffen School of Medicine

Locations

UCLA Cousins Center for Psychoneuroimmunology

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21MH113915

Identifier Type: NIH

Identifier Source: secondary_id

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R21MH113915

Identifier Type: NIH

Identifier Source: org_study_id

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