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Dietary Supplement

MoodElite T-4003-1 for Depression

Phase 1 & 2

Waitlist Available

Led By David Crowley, MD

Research Sponsored by Chenland Nutritionals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 0, 42 and day 56 (follow-up)

Summary

This trial tests MoodElite T-4003-1, a mood-improving supplement, on healthy adults with mild to moderate depressive symptoms. The study will measure changes in mood and sleep quality over several weeks, comparing the supplement's effects to another product.

Eligible Conditions

Depression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 0, 42 and day 56 (follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 0, 42 and day 56 (follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 0, 42 and day 56 (follow-up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in mood between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by BDI-ll

Change in total mood disturbance between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS Questionnaire

Secondary study objectives

Change in anger-hostility between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS

Change in blood melatonin levels between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation

Confusion

+10 more

Other study objectives

Change in Aspartate Aminotransferase levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo

Change in Red Blood Cell Count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo

Change in alanine aminotransferase levels from baseline to baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo

+26 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: MoodElite T-4003-1Experimental Treatment1 Intervention

Participants will be instructed to take two capsules of MoodElite T-4003-1 once daily with water, after dinner without food starting on Day 0 for 42 days. If a dose is missed participants are instructed to take the dose as soon as they remember. Participants will be advised not to exceed 4 capsules daily.

Group II: ComparatorActive Control1 Intervention

Participants will be instructed to take two capsules of comparator once daily with water, after dinner without food starting on Day 0 for 42 days. If a dose is missed participants are instructed to take the dose as soon as they remember. Participants will be advised not to exceed 4 capsules daily.

Group III: PlaceboPlacebo Group1 Intervention

Participants will be instructed to take two capsules of placebo once daily with water, after dinner without food starting on Day 0 for 42 days. If a dose is missed participants are instructed to take the dose as soon as they remember. Participants will be advised not to exceed 4 capsules daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MoodElite T-4003-1

2022

Completed Phase 2

~50

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