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Trial record 17 of 586 for:    maltodextrin

Rapid Antidepressant Effects of Leucine

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ClinicalTrials.gov Identifier: NCT03079297
Recruitment Status : Recruiting
First Posted : March 14, 2017
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center

Brief 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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: L-Leucine Other: Maltodextrin Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Double-Blind Randomized Placebo-Controlled Crossover Study to Investigate Rapid Antidepressant Effects of Leucine
Actual Study Start Date : March 9, 2017
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
Drug Information available for: Leucine

Arm Intervention/treatment
Experimental: L-leucine
4 gm L-leucine by mouth twice daily for two weeks
Drug: L-Leucine
L-leucine is an essential amino acid which will be provided as an effervescent powder mixture to participants.
Other Name: Leucine

Placebo Comparator: Maltodextrin
4 gm maltodextrin by mouth twice daily for two weeks
Other: 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
Other Name: Placebo




Primary Outcome Measures :
  1. Comparison of reduction in QIDS-SR after 14 days of treatment with L-leucine (LEU) and placebo (PBO) in MDD patients. [ Time Frame: 14 days ]
    QIDS-SR measures self-reported depression severity


Secondary Outcome Measures :
  1. Percentage of MDD patients with 50% or greater reduction in depression severity after 14 days of LEU and PBO treatments. [ Time Frame: Baseline to 14 days ]
    Response criteria defined based on QIDS-SR score at baseline and 14 days after treatment initiation

  2. Percentage of MDD patients with QIDS-SR score less than or equal to 5 at 14 days of LEU and PBO treatments. [ Time Frame: 14 days ]
    Remission operationalized as QIDS-SR <=5

  3. Rates of adverse effects after 3 days, 7 days and 14 days of LEU and PBO treatments. [ Time Frame: 3 days, 7 days, and 14 days ]
    Adverse effect burden will be measured with Frequency Intensity and Burden of Side-effect rating scale (FIBSER)

  4. Change in fatigue symptoms from baseline after 3, 7, and 14 days of LEU and PBO treatments measured with Multidimensional fatigue inventory. [ Time Frame: 3 days, 7 days, and 14 days ]
    Fatigue will be measured with Multidimensional fatigue inventory

  5. Change in psychosocial function from baseline after 3, 7, and 14 days of LEU and PBO treatments measured using Work and Social Adjustment Scale. [ Time Frame: 3 days, 7 days, and 14 days ]
    Psychosocial function will be measured using Work and Social Adjustment Scale

  6. Change in anhedonia from baseline after 3, 7, and 14 days of LEU and PBO treatments measured using Snaith-Hamilton Pleasure Scale (SHAPS) [ Time Frame: 3 days, 7 days, and 14 days ]
    Anhedonia will be measured using Snaith-Hamilton Pleasure Scale (SHAPS)



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079297


Contacts
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Contact: Maria Monastirsky 2146480174 maria.monastirsky@utsouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Maria Monastirsky, BSN       maria.monastirsky@utsouthwestern.edu   
Sub-Investigator: Manish K Jha, M.D.         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Madhukar H Trivedi, M.D. UT Southwestern Medical Center

Publications:
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Responsible Party: Madhukar H. Trivedi, MD, MD, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03079297     History of Changes
Other Study ID Numbers: STU 082016-037
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center:
Antidepressant
Inflammation
Biomarker
Depression
Treatment Resistant Depression
Leucine
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs