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NCT03079297 · ClinicalTrials.gov registry record · Phase 2

Rapid Antidepressant Effects of Leucine

A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.

Terminated
Registry status
Phase 2
Development phase
16
Enrollment target

NCT03079297: Clinical Trial Phase 2 study, sponsored by University of Texas Southwestern Medical Center.

NCT03079297 is a Phase 2 study that was terminated before completion, run by University of Texas Southwestern Medical Center. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03079297, a Phase 2 study, was terminated before completion, sponsored by University of Texas Southwestern Medical Center.

TERMINATED
Registry status
Phase 2
Development phase
16 participants
Enrollment target

Study Summary

This randomized double-blind placebo-controlled crossover study seeks to evaluate the antidepressant effect of L-leucine, an essential amino acid, in patients with Major Depressive Disorder (MDD).

Primary Outcome

The Quick Inventory of Depressive Symptomatology, self-report (QIDS-SR), self-report is a 16-item measure of depression severity that includes the 9 criterion symptoms for MDD. Items are scored on a 4-point Likert scale, ranging from 0 to 3 (total score range, 0-27). Totals scores of ≤ 5 indicate no depression; 6-10 indicates mild depression; 11-15 indicates moderate depression; 16-20 indicates severe depression; and ≥ 21 indicates very severe depression. For purposes of this report, severe and

Interventions

  • OTHER Maltodextrin
  • DRUG L-Leucine

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2017-03-09
Est. Completion 2021-10-04
Phase Phase 2

Why NCT03079297 stopped before completion

NCT03079297 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 2 interventions - of which Maltodextrin is the first listed.

NCT03079297 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03079297 about?

NCT03079297 is a clinical study titled "Rapid Antidepressant Effects of Leucine". This randomized double-blind placebo-controlled crossover study seeks to evaluate the antidepressant effect of L-leucine, an essential amino acid, in patients with Major Depressive Disorder (MDD).

What is the current status of trial NCT03079297?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2017-03-09. Estimated completion is 2021-10-04.

What interventions are being tested in trial NCT03079297?

The interventions under investigation include: Maltodextrin (OTHER), L-Leucine (DRUG).

Who is sponsoring clinical trial NCT03079297?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03079297's enrollment target sits among peer trials

16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03079297, the US trial registry maintained by the National Library of Medicine. NCT03079297 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.