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

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

44 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug MoodElite T-4003-1?

Research shows that similar treatments, like Org 3770, have been effective in treating depression, as they performed better than a placebo in clinical trials. Additionally, gabapentin and modafinil, which are used for mood disorders, have shown promise in improving symptoms when used alongside other treatments. ^{1 2 3 4 5}

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. In trials, the most common side effects were dizziness, double vision, drowsiness, headache, unsteady movement, and weakness. Some patients experienced rashes, and a few were withdrawn from studies due to adverse effects like nausea and vomiting, but no significant changes in vital signs or lab results were noted. ^{6 7 8 9 10}

How does the treatment MoodElite T-4003-1 differ from other treatments for mood disorders?

MoodElite T-4003-1 may be unique due to its potential involvement with the protein kinase C (PKC) signaling system, which is a novel target for mood disorder treatments. This pathway is linked to mood regulation and could offer faster and more effective results compared to current mood stabilizers and antidepressants. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Research Team

David Crowley, MD

Principal Investigator

KGK Science Inc.

Eligibility Criteria

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

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)

Treatment Details

Interventions

• Comparator
• MoodElite T-4003-1
• Placebo

Participant Groups

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

Findings from Research

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A double-blind placebo-controlled study of Org 3770 in depressed outpatients. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Adjunctive gabapentin in treatment-resistant depression: a retrospective chart review. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Citalopram, methylphenidate, or their combination in geriatric depression: a randomized, double-blind, placebo-controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled, dose-ranging study of lisdexamfetamine dimesylate augmentation for major depressive disorder in adults with inadequate response to antidepressant therapy. [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of adjunctive modafinil/armodafinil in bipolar depression: A meta-analysis of randomized controlled trials. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Duloxetine for the treatment of major depressive disorder: a closer look at efficacy and safety data across the approved dose range. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Association of Optimal Lamotrigine Serum Levels and Therapeutic Efficacy in Mood Disorders: A Systematic Review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The efficacy of agomelatine in elderly patients with recurrent major depressive disorder: a placebo-controlled study. [2022]

9. England 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. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Human safety of lamotrigine. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Photobiomodulation Therapy Ameliorates Glutamatergic Dysfunction in Mice with Chronic Unpredictable Mild Stress-Induced Depression. [2021]

12. England pubmed.ncbi.nlm.nih.gov

SKF83959 produces antidepressant effects in a chronic social defeat stress model of depression through BDNF-TrkB pathway. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Protein kinase Mζ in medial prefrontal cortex mediates depressive-like behavior and antidepressant response. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Memantine in the preventive treatment of refractory migraine. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

A role for the PKC signaling system in the pathophysiology and treatment of mood disorders: involvement of a functional imbalance? [2021]