Leucine for Depression Study (L-DEP)

NCT03557684, Early phase 1, Terminated, University of California, Los Angeles; results first posted 2023-06-08

Trial 11

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

Field	Value	Source
Title	Leucine for Depression Study (L-DEP)	ClinicalTrials.gov
NCT number	NCT03557684	ClinicalTrials.gov
Status	Terminated	ClinicalTrials.gov
Phases	Early phase 1	ClinicalTrials.gov
Enrollment	59 participants, actual	ClinicalTrials.gov
Lead sponsor	University of California, Los Angeles	ClinicalTrials.gov
Conditions	Depression	ClinicalTrials.gov
Interventions	leucine, PO placebo, lipopolysaccharide (LPS), IV placebo	ClinicalTrials.gov
First posted	2018-06-15	ClinicalTrials.gov
Last updated	2023-06-08	ClinicalTrials.gov
Results first posted	2023-06-08	ClinicalTrials.gov

Registered outcomes 15

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

List	Outcome	Time frame	Description	Source
Primary	Change in Depressed Mood From Baseline	At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administration	Depression Subscale of the Short Form of the Profile of Mood States (POMS-SF): total score ranges from 0 to 32; higher values represent worse outcome, i.e., more severe depressed mood; the absolute values at each time point are presented here rather than change of values between time points; zero (0) in mean and standard deviation reflect measured data and not placeholder values.	ClinicalTrials.gov
Secondary	Change in Depressive Symptoms From Baseline	At baseline and then at 2 and 4 hours after LPS (or saline) administration	Montgomery-Asberg Depression Rating Scale (MADRS): a clinician-rated questionnaire of depressive symptoms with scores ranging from 0 to 60, with higher scores indicating more severe depressive symptoms.	ClinicalTrials.gov
Secondary	Change in Feelings of Social Disconnection From Baseline	At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administration	Feelings of Social Disconnection Scale: a self-report questionnaire of feelings of social disconnection with scores ranging from 0 to 28, with higher scores indicating more severe feelings of social disconnection.	ClinicalTrials.gov
Secondary	Change in Fatigue From Baseline	At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administration	Fatigue Subscale of the Short Form of the Profile of Mood States (POMS-SF): total score ranges from 0 to 20; higher values represent worse outcome, i.e., more severe fatigue; the absolute values at each time point are presented here rather than change of values between time points.	ClinicalTrials.gov
Secondary	Change in Confusion From Baseline	At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administration	Confusion Subscale of the Short Form of the Profile of Mood States (POMS-SF): total score ranges from 0 to 20; higher values represent worse outcome, i.e., more severe confusion; the absolute values at each time point are presented here rather than change of values between time points; zero (0) in mean and standard deviation reflect measured data and not placeholder values.	ClinicalTrials.gov
Secondary	Change in Memory Domains of Cognitive Function From Baseline	At baseline and then 3 hours after LPS (or saline) administration	Memory domains of cognitive function were measured using the computerized tests from CNS Vital Signs™: verbal memory using "Verbal Memory Test" (total scores ranging from 0 to 60; higher scores mean a better outcome); and visual memory using "Visual Memory Test" (total scores ranging from 0 to 60; higher scores mean a better outcome). The absolute values at each time point are presented.	ClinicalTrials.gov
Secondary	Change in Non-memory Domains of Cognitive Function From Baseline	At baseline and then 3 hours after LPS (or saline) administration	Non-memory domains of cognitive function were measured using the computerized tests from CNS Vital Signs™: executive function using "Stroop Test" (average reaction time in milliseconds thus ranging from 0 to infinite; shorter reaction time means a better outcome); and attention using "Shifting Attention Test" (average reaction time for correct responses in milliseconds thus ranging from 0 to infinite; shorter reaction time means a better outcome) and "Continuous Performance Test" (average reaction time for correct responses in milliseconds thus ranging from 0 to infinite; shorter reaction time means a better outcome). The absolute values at each time point are presented.	ClinicalTrials.gov
Other	Anhedonia	2 hours after LPS (or saline) administration	Facial expressions and skin conductance in response to funny film clips using the iMotions®Attention Tool (iMotions Inc., Cambridge, MA) which performs automatic analysis of facial expressions from video and integrates simultaneous measurement of skin conductance	ClinicalTrials.gov
Other	Subjective Sensitivity to Social Rejection	2 hours after LPS (or saline) administration	Using the Cyberball Social Exclusion Task, feelings of social distress to social rejection are evaluated based on a scale with the total score ranging from 0 to 48; higher values represent worse outcome, i.e., more severe social distress. The Overall Number of Participants Analyzed is different from numbers of participants reported in the Participant Flow module because some participants declined to complete this task.	ClinicalTrials.gov
Other	Negative Bias in Facial Emotion Recognition	2 hours after LPS (or saline) administration	Emotional Face Recognition Task consists in showing participants a series of black and white photographs (Ekman Pictures of facial affect), in which the facial expression is morphed from neutral to either Sad, Angry, or Happy. For each image, participants will be asked to make a forced choice about the emotion expressed, and rate their certainty.	ClinicalTrials.gov
Other	Subjective Sensitivity to Social Acceptance	2 hours after drug administration	Prior to the experimental session, participants are asked to complete a survey that contains several personality questionnaires and are video-recorded for 2-5 minutes as they discuss what they like about themselves. Participants are told that 8 people will form impressions of them by selecting personality traits to describe them. Participants then see a photograph of themselves along with a descriptive word underneath (supposedly provided by the evaluators), which is pre-rated based on desirability, and are asked to rate subjective happiness when each of the feedback items is presented. The total score of the scale ranges from 0 to 105; higher values represent better outcome, i.e., higher social reward. The Overall Number of Participants Analyzed is different from numbers of participants reported in the Participant Flow module because some participants declined to complete this task.	ClinicalTrials.gov
Other	Reward	2 hours after LPS (or saline) administration	Reward Learning Task (a laboratory based probabilistic reward task that objectively measures participants' ability to modulate behavior as a function of reward)	ClinicalTrials.gov
Other	Change in Proinflammatory Cytokines From Baseline	At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administration	Plasma proinflammatory cytokines (interleukin-1 receptor antagonist, interleukin-6, tumor necrosis factor-α, and soluble tumor necrosis factor receptor)	ClinicalTrials.gov
Other	Change in Kynurenine Metabolites From Baseline	At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administration	Plasma tryptophan, kynurenine, quinolinic acid, and kynurenic acid	ClinicalTrials.gov
Other	Change in Gene Expression From Baseline	At baseline and 30 minutes after LPS (or saline) administration	Genome-wide transcriptional profiling conducted using Illumina HT-12 BeadArrays	ClinicalTrials.gov

Outcomes 15

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

Type	Outcome	Time frame	Population	Units	Measured as	Source
PRIMARY	Change in Depressed Mood From Baseline	At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administration		score on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Change in Depressive Symptoms From Baseline	At baseline and then at 2 and 4 hours after LPS (or saline) administration		score on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Change in Feelings of Social Disconnection From Baseline	At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administration		score on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Change in Fatigue From Baseline	At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administration		score on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Change in Confusion From Baseline	At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administration		score on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Change in Memory Domains of Cognitive Function From Baseline	At baseline and then 3 hours after LPS (or saline) administration		score on a scale	MEAN	ClinicalTrials.gov
OTHER_PRE_SPECIFIED	Anhedonia	2 hours after LPS (or saline) administration	The study was paused during the COVID pandemic because endotoxin, a biologic derived from an infectious agent, was being used. Then, the request for COIVD supplement to NIMH was denied, and due to the lack of funds, the study was prematurely terminated. As the raw data of this particular outcome measure consist in recordings of facial expression and skin conductance, further processing by a specialized technician and additional funds are required. Thus we are currently unable to report the data.			ClinicalTrials.gov
OTHER_PRE_SPECIFIED	Subjective Sensitivity to Social Rejection	2 hours after LPS (or saline) administration		score on a scale	MEAN	ClinicalTrials.gov
OTHER_PRE_SPECIFIED	Negative Bias in Facial Emotion Recognition	2 hours after LPS (or saline) administration	The study was paused during the COVID pandemic because endotoxin, a biologic derived from an infectious agent, was being used. Then, the request for COIVD supplement to NIMH was denied, and due to the lack of funds, the study was prematurely terminated. As the raw data of this particular outcome measure require further processing by a specialized technician and thus additional funds, we are currently unable to process and report the data.			ClinicalTrials.gov
OTHER_PRE_SPECIFIED	Subjective Sensitivity to Social Acceptance	2 hours after drug administration		score on a scale	MEAN	ClinicalTrials.gov
OTHER_PRE_SPECIFIED	Reward	2 hours after LPS (or saline) administration	The study was paused during the COVID pandemic because endotoxin, a biologic derived from an infectious agent, was being used. Then, the request for COIVD supplement to NIMH was denied, and due to the lack of funds, the study was prematurely terminated. As the raw data of this particular outcome measure require further processing by a specialized technician and thus additional funds, we are currently unable to process and report the data.			ClinicalTrials.gov
OTHER_PRE_SPECIFIED	Change in Proinflammatory Cytokines From Baseline	At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administration	The study was paused during the COVID pandemic because endotoxin, a biologic derived from an infectious agent, was being used. Then, the request for COIVD supplement to NIMH was denied, and due to the lack of funds, the study was prematurely terminated. As the raw data of this particular outcome measure require further processing and thus further funds, we are currently unable to process and report the data.			ClinicalTrials.gov
OTHER_PRE_SPECIFIED	Change in Kynurenine Metabolites From Baseline	At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administration	The study was paused during the COVID pandemic because endotoxin, a biologic derived from an infectious agent, was being used. Then, the request for COIVD supplement to NIMH was denied, and due to the lack of funds, the study was prematurely terminated. Due to the lack of funds, the blood sample could not be assayed, and we are currently unable to report the data for this particular outcome measure.			ClinicalTrials.gov
OTHER_PRE_SPECIFIED	Change in Gene Expression From Baseline	At baseline and 30 minutes after LPS (or saline) administration	The study was paused during the COVID pandemic because endotoxin, a biologic derived from an infectious agent, was being used. Then, the request for COIVD supplement to NIMH was denied, and due to the lack of funds, the study was prematurely terminated. Due to the lack of funds, the blood sample could not be assayed, and we are currently unable to report the data for this particular outcome measure.			ClinicalTrials.gov
SECONDARY	Change in Non-memory Domains of Cognitive Function From Baseline	At baseline and then 3 hours after LPS (or saline) administration		milliseconds	MEAN	ClinicalTrials.gov

Results by group 188

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

Outcome	Group	Category	Value	Spread	Units	Source
Change in Depressed Mood From Baseline	PO Leucine & IV LPS	Baseline	.6818182	Standard Deviation 1.86155	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Placebo & IV LPS	Baseline	.5294118	Standard Deviation 1.178858	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Leucine & IV Placebo	Baseline	.2857143	Standard Deviation .48795	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Placebo & IV Placebo	Baseline	.6	Standard Deviation 1.074968	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Leucine & IV LPS	1 hour	1.619048	Standard Deviation 3.879126	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Placebo & IV LPS	1 hour	.7647059	Standard Deviation 1.480262	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Leucine & IV Placebo	1 hour	.375	Standard Deviation .7440238	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Placebo & IV Placebo	1 hour	0	Standard Deviation 0	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Leucine & IV LPS	1.5 hours	1.55	Standard Deviation 3.817894	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Placebo & IV LPS	1.5 hours	1	Standard Deviation 2.371708	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Leucine & IV Placebo	1.5 hours	.25	Standard Deviation .46291	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Placebo & IV Placebo	1.5 hours	.1	Standard Deviation .3162278	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Leucine & IV LPS	2 hours	1	Standard Deviation 3.829708	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Placebo & IV LPS	2 hours	1.111111	Standard Deviation 3.103866	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Leucine & IV Placebo	2 hours	.7142857	Standard Deviation 1.253566	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Placebo & IV Placebo	2 hours	.4	Standard Deviation .6992059	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Leucine & IV LPS	3 hours	.5909091	Standard Deviation 2.363595	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Placebo & IV LPS	3 hours	.5625	Standard Deviation 1.364734	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Leucine & IV Placebo	3 hours	.375	Standard Deviation 1.06066	score on a scale	ClinicalTrials.gov
Change in Depressed Mood From Baseline	PO Placebo & IV Placebo	3 hours	.1111111	Standard Deviation .3333333	score on a scale	ClinicalTrials.gov

Participant flow 12

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

Period	Milestone	Group	Participants	Source
Overall Study	STARTED	PO Leucine & IV LPS	23	ClinicalTrials.gov
Overall Study	STARTED	PO Placebo & IV LPS	18	ClinicalTrials.gov
Overall Study	STARTED	PO Leucine & IV Placebo	8	ClinicalTrials.gov
Overall Study	STARTED	PO Placebo & IV Placebo	10	ClinicalTrials.gov
Overall Study	COMPLETED	PO Leucine & IV LPS	23	ClinicalTrials.gov
Overall Study	COMPLETED	PO Placebo & IV LPS	18	ClinicalTrials.gov
Overall Study	COMPLETED	PO Leucine & IV Placebo	8	ClinicalTrials.gov
Overall Study	COMPLETED	PO Placebo & IV Placebo	10	ClinicalTrials.gov
Overall Study	NOT COMPLETED	PO Leucine & IV LPS	0	ClinicalTrials.gov
Overall Study	NOT COMPLETED	PO Placebo & IV LPS	0	ClinicalTrials.gov
Overall Study	NOT COMPLETED	PO Leucine & IV Placebo	0	ClinicalTrials.gov
Overall Study	NOT COMPLETED	PO Placebo & IV Placebo	0	ClinicalTrials.gov

Adverse events 0

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	Source

Adverse event totals 12

The totals the trial posted for each group.

Total	Group	At risk	Source
Total, all-cause mortality	PO Leucine & IV LPS	23	ClinicalTrials.gov
Total, all-cause mortality	PO Placebo & IV LPS	18	ClinicalTrials.gov
Total, all-cause mortality	PO Leucine & IV Placebo	8	ClinicalTrials.gov
Total, all-cause mortality	PO Placebo & IV Placebo	10	ClinicalTrials.gov
Total, other adverse events	PO Leucine & IV LPS	23	ClinicalTrials.gov
Total, other adverse events	PO Placebo & IV LPS	18	ClinicalTrials.gov
Total, other adverse events	PO Leucine & IV Placebo	8	ClinicalTrials.gov
Total, other adverse events	PO Placebo & IV Placebo	10	ClinicalTrials.gov
Total, serious adverse events	PO Leucine & IV LPS	23	ClinicalTrials.gov
Total, serious adverse events	PO Placebo & IV LPS	18	ClinicalTrials.gov
Total, serious adverse events	PO Leucine & IV Placebo	8	ClinicalTrials.gov
Total, serious adverse events	PO Placebo & IV Placebo	10	ClinicalTrials.gov

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source

Grants 1

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	Source
R21MH113915	An Experimental Treatment Approach for Inflammation-Induced Depression	CHO, JOSHUA HYONG-JIN	UNIVERSITY OF CALIFORNIA LOS ANGELES	NATIONAL INSTITUTE OF MENTAL HEALTH	2018 to 2019	NIH RePORTER

Trial comparisons 0

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

Comparison	Source

Tests 4

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
Ball-Toss Game	Other outcome	ConductCognition
Continuous Performance Test	Secondary outcome	ConductCognition
Probabilistic Reward Task	Other outcome	ConductCognition
Stroop Color-Word Test	Secondary outcome	ConductCognition

Source 5

Field	Value	Source
Release	trials-2026-11-12-0.4.0	ClinicalTrials.gov
Release manifest SHA-256	0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov
NIH clinical studies file	2026-11-13	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)