Rapid Antidepressant Effects of Leucine

The University of Texas System (UT)

Status and phase

Terminated

Phase 2

Conditions

Major Depressive Disorder

Treatments

Other: Maltodextrin

Drug: L-Leucine

Study type

Interventional

Funder types

Other

Identifiers

NCT03079297

STU 082016-037

Details and patient eligibility

About

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).

Full description

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.

Enrollment

16 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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.