MoodElite for Depression

Overseen By Mal Evans, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Chenland Nutritionals Inc.

Must not be taking: Antidepressants, Sleep aids, Cannabinoids

Disqualifiers: Pregnancy, Major depression, Bipolar, Insomnia, others

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests MoodElite T-4003-1, a potential new treatment to improve mood in people with mild to moderate depressive symptoms who aren't eligible for traditional therapeutic interventions. The study aims to determine the safety and effectiveness of this treatment. Participants will take capsules daily, and the trial will compare MoodElite T-4003-1 to a placebo (a pill without active ingredients) and an active comparator (another treatment for comparison). People with mild depressive symptoms who can maintain their current lifestyle might be a good fit for this trial. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial requires that you do not use prescribed medications, over-the-counter medications, or supplements for depression or sleep. If you are on medications that interact with Hypericum perforatum, you may also need to stop those. Please discuss with the study team to understand how this applies to your specific situation.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Researchers are testing MoodElite T-4003-1 to determine if it can safely improve mood in people with mild to moderate depressive symptoms who don't require other treatments. Clear information about its safety in humans remains limited, as the study is still in the early stages. In the phase 1 and 2 trial, researchers are assessing how well participants tolerate the treatment and identifying potential side effects. Treatments in these early phases are typically evaluated for safety in humans for the first time, so the full picture of risks and side effects is not yet completely known. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for depressive symptoms?

Unlike standard antidepressants like SSRIs or SNRIs, MoodElite T-4003-1 is unique because it is specifically designed for individuals with mild to moderate depressive symptoms who aren't eligible for traditional therapeutic interventions. While most treatments for depression target serotonin or norepinephrine pathways, MoodElite T-4003-1 offers a novel approach, potentially acting on different neurological pathways to improve mood. Researchers are excited about this treatment because it could provide a new option for those who fall outside the typical treatment criteria, offering hope for effective symptom management without the side effects often associated with conventional antidepressants.

What evidence suggests that this trial's treatments could be effective for improving mood in individuals with mild to moderate depressive symptoms?

Research has shown that MoodElite T-4003-1, a treatment in this trial, is being tested for its potential to improve mood in individuals with mild to moderate depression. While detailed results from human studies are not yet available, the treatment functions by balancing brain chemicals that influence mood. This mechanism is similar to that of some antidepressants, leading researchers to hope that MoodElite T-4003-1 could be effective. Early findings suggest promise, but further information is needed to confirm its benefits. Participants in this trial may receive MoodElite T-4003-1, a comparator, or a placebo to assess its effectiveness. ^{4 5 6 7 8}

Who Is on the Research Team?

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Individual is not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least one year prior to screening

Or, Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include: Injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) Double-barrier method Intrauterine devices Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) Vasectomy of partner at least 6 months prior to screening

Individuals with mild to mild-moderate depressive symptoms, as determined by a score of 14-24 on the BDI-II at screening, and as assessed by the Qualified Investigator (QI)

Exclusion Criteria

You have a history of severe or ongoing depression, as determined by a specific assessment tool called the QI.

Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients

You have a history of mental health disorders like bipolar disorder, personality disorder, or other brain disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MoodElite T-4003-1, comparator, or placebo for 42 days

6 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Comparator
• MoodElite T-4003-1
• Placebo

How Is the Trial Designed?

Group I: MoodElite T-4003-1 Experimental Treatment 1 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: Comparator Active Control 1 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

Chenland Nutritionals Inc.

Lead Sponsor

Trials

4

Recruited

140+

KGK Science Inc.

Industry Sponsor

Trials

82

Recruited

6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution

Published Research Related to This Trial

In a placebo-controlled study involving 222 elderly patients with major depressive disorder, agomelatine (25-50 mg/d) significantly improved depressive symptoms compared to placebo, as measured by the Hamilton Depression Rating Scale (HDRS17).

Agomelatine was well tolerated among participants, showing minimal side effects compared to placebo, indicating it is a safe treatment option for elderly patients with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of agomelatine in elderly patients with recurrent major depressive disorder: a placebo-controlled study. Heun, R., Ahokas, A., Boyer, P., et al.[2022]

Edivoxetine, when used as an adjunctive treatment to SSRIs, showed a higher rate of treatment-emergent adverse events (TEAEs) compared to placebo, with 56.8% of patients reporting at least one TEAE, indicating a need for careful monitoring of side effects.

The safety profile of edivoxetine included significant increases in blood pressure and pulse rate, but no clinically significant changes in laboratory measures, suggesting that while it may enhance treatment efficacy, it also carries specific cardiovascular considerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of edivoxetine as adjunctive treatment to selective serotonin reuptake inhibitor antidepressants for patients with major depressive disorder. Martinez, JM., Ferguson, MB., Pangallo, BA., et al.[2020]

Lamotrigine (LTG) was found to have a similar safety profile to placebo in a pooled analysis of four double-blind trials involving 92 patients, with only two patients withdrawing due to adverse effects.

In a larger group of 572 patients from open studies, common side effects included dizziness and headache, but no significant clinical changes or serious adverse events were linked to LTG, indicating it is generally safe when added to existing antiepileptic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human safety of lamotrigine. Betts, T., Goodwin, G., Withers, RM., et al.[2019]

In a double-blind trial involving 90 patients with moderate to severe major depressive episodes, Org 3770 demonstrated significant efficacy compared to placebo, particularly in the first four weeks and at the end of the six-week treatment period.

Org 3770 was well-tolerated, with only minor side effects such as somnolence and increased appetite, indicating it is a safe option for treating major depressive disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind placebo-controlled study of Org 3770 in depressed outpatients. Claghorn, JL., Lesem, MD.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05318456

The Safety and Efficacy of MoodElite T-4003-1 on ... The objective of this study is to investigate the safety and efficacy of 42-day supplementation of MoodElite T-4003-1 on improving mood in healthy adults.

2. ctv.veeva.com ctv.veeva.com/study/the-safety-and-efficacy-of-moodelite-t-4003-1-on-improving-mood-in-a-healthy-adult-population-with-m

The Safety and Efficacy of MoodElite T-4003-1 on Improving ... The objective of this study is to investigate the efficacy and safety of MoodElite T-4003-1 on improving mood in a healthy adult population ...

3. go.drugbank.com go.drugbank.com/conditions/DBCOND0034411

Mood (DBCOND0034411) 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 ...

4. beckleypsytech.com beckleypsytech.com/posts/atai-life-sciences-and-beckley-psytech-report-positive-phase-2a-data-with-two-dose-induction-regimen-of-bpl-003-in-patients-with-treatment-resistant-depression

atai Life Sciences and Beckley Psytech Report Positive ... The results demonstrate that a second dose of BPL-003 at Week 2 has the potential to induce greater antidepressant effects, as evidenced by ...

5. beckleypsytech.com beckleypsytech.com/posts/atai-life-sciences-and-beckley-psytech-announce-positive-topline-results-from-the-phase-2b-study-of-bpl-003-in-patients-with-treatment-resistant-depression

atai Life Sciences and Beckley Psytech Announce Positive ... A single 12 mg dose of BPL-003 demonstrated a statistically significant reduction in depressive symptoms, as measured by the Montgomery-Åsberg Depression ...

6. sigma.larvol.com sigma.larvol.com/facility.php?FacilityId=2827286

KGK Clinical Trial Centers Graminex LLC, KGK Science Inc. Menopausal Women. 11/25. 11/25. NCT05318456: The Safety and Efficacy of MoodElite T-4003-1 on Improving Mood in a Healthy Adult ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05318456

The Safety and Efficacy of MoodElite T-4003-1 on ... The objective of this study is to investigate the efficacy and safety of MoodElite T-4003-1 on improving mood in a healthy adult population with mild to ...

8. withpower.com withpower.com/trial/phase-2-depression-2-2022-83865

The Safety and Efficacy of MoodElite T-4003-1 on Improving ... What safety data exists for the treatment evaluated under different names? The safety of lamotrigine (also known as LAM) has been evaluated in several studies.