Rapid Antidepressant Effects of Leucine

• Status: Suspended
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Antidepressive Agents

Criteria

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.