Rapid Antidepressant Effects of Leucine

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-09

Study Completion Date

2021-10-04

Brief Summary

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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).

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Detailed Description

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This is a pilot phase II clinical trial of L-leucine to test its efficacy in reducing depressive symptoms in MDD patients, especially those who exhibit increased inflammation. The determination of increased inflammation will be done post-hoc. During the screening visit, all study participants will provide demographic information and complete self-report assessments and clinician evaluations and examinations. Blood and urine tests will also be performed. All participants who meet eligibility criteria and are willing to proceed with the study will enter this 6-week study after being randomized to two-week course of either L-leucine or placebo. In this cross-over study, participants will be crossed over to the second treatment after 2 weeks of washout. The study period will last 42 days (6 weeks) from the baseline visit. Both L-leucine and placebo will be provided as an effervescent mixture powder. Investigators hypothesize that MDD subjects will have greater reduction in depression severity on leucine as compared to placebo.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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L-leucine

4 gm L-leucine by mouth twice daily for two weeks

Group Type EXPERIMENTAL

L-Leucine

Intervention Type DRUG

L-leucine is an essential amino acid which will be provided as an effervescent powder mixture to participants.

Maltodextrin

4 gm maltodextrin by mouth twice daily for two weeks

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type OTHER

Maltodextrin is a nonsweet carbohydrate which will be provided as an effervescent powder mixture similar in taste and appearance to the L-leucine containing effervescent powder mixture

Interventions

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L-Leucine

L-leucine is an essential amino acid which will be provided as an effervescent powder mixture to participants.

Intervention Type DRUG

Maltodextrin

Maltodextrin is a nonsweet carbohydrate which will be provided as an effervescent powder mixture similar in taste and appearance to the L-leucine containing effervescent powder mixture

Intervention Type OTHER

Other Intervention Names

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Leucine Placebo

Eligibility Criteria

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Inclusion Criteria

* Current primary diagnosis of nonpsychotic major depressive disorder.
* Stable antidepressant dose of no more than one antidepressant medication for 4 weeks and no anticipated changes during the study period.
* Stable doses of all concomitant medications for over 6 weeks.
* No more than two failed antidepressant trials of adequate dose and duration, as defined by ATRQ, in the current episode.

Exclusion Criteria

* Psychiatric co-morbidity posing safety risk.
* Pregnant or breastfeeding or plan to become pregnant over the ensuing 2 months following study entry or are sexually active and not using adequate contraception
* Exclusionary psychiatric conditions (such as substance dependence in the last 6 months, substance abuse in the last 2 months, or lifetime history of psychotic disorders.
* Unstable or terminal general medical condition (GMC).
* Concomitant medications that interact with L-leucine (e.g. sildenafil).
* Vagus nerve stimulation, ECT, or rTMS, or other somatic antidepressant treatment during current episode
* Inadequately controlled hypothyroidism.
* Therapy that is depression specific, such as CBT or Interpersonal Psychotherapy of Depression.
* Hypersensitivity to L-leucine
* Have Maple Syrup Urine Disease.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No