← Back to Search

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)

Awards & highlights

Study Summary

This trial will test if the drug MoodElite is effective and safe in improving mood for people with mild to moderate depression who can't get other therapy.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Chenland Nutritionals Inc.Lead Sponsor

3 Previous Clinical Trials

96 Total Patients Enrolled

KGK Science Inc.Industry Sponsor

78 Previous Clinical Trials

6,116 Total Patients Enrolled

David Crowley, MDPrincipal InvestigatorKGK Science Inc.

35 Previous Clinical Trials

2,709 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this trial restricted to people aged 55 and under?

"The age range established for qualification into this trial is 18 to 65 years of age."

Answered by AI

What criteria must be met for someone to partake in this medical experiment?

"To meet the eligibility criteria for this research, individuals must have a diagnosis of depression and be between 18-65 years old. Approximately 45 participants are required to join the trial."

Answered by AI

Is it still possible for individuals to join this research investigation?

"According to the listing on clinicaltrials.gov, this experiment is actively recruiting volunteers. It was first published on March 24th 2022 and updated most recently on April 1st 2022."

Answered by AI

What tangible outcomes is this research endeavor attempting to accomplish?

"The primary aim of this medical trial, which will be monitored at Days 0, 42 and 56 (follow-up), is to ascertain the change in mood among MoodElite T-4003-1 users compared with EasyMind T-4008-1 and placebo patients from baseline to day 42 post supplementation by using the BDI-ll. Additionally, secondary objectives involve assessing changes in confusion levels through POMS measurement of anger/hostility and vigor between these three groups from pre to post intervention. The Profile of Mood States Questionnaire has been widely used for clinical trials due its demonstrated validity as it captures both short term feelings"

Answered by AI

What is the scope of population under observation for this clinical experiment?

"Affirmative. Clinicaltrials.gov contains information indicating that this research effort, which began on March 24th 2022, is actively recruiting participants. 45 individuals will be accepted from a single medical institution."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Safety and Efficacy of MoodElite T-4003-1 on Improving Mood in a Healthy Adult Population With Mild to Moderate Depressive Symptoms Not Eligible for Therapeutic Intervention

2022. "The Safety and Efficacy of MoodElite T-4003-1 on Improving Mood in a Healthy Adult Population With Mild to Moderate Depressive Symptoms Not Eligible for Therapeutic Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05318456.