Status:
COMPLETED
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
Lead Sponsor:
Chenland Nutritionals Inc.
Collaborating Sponsors:
KGK Science Inc.
Conditions:
Mood
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
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 moderate depressive symptoms not eligible for t...
Detailed Description
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. The efficacy of MoodElite T-4003-1 on mood wi...
Eligibility Criteria
Inclusion
- Individuals 18-65 years of age, inclusive
- 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)
- Education level no less than that of primary school
- Individuals who can read and write in English and can understand the BDI-II
- Agrees to maintain current lifestyle habits as much as possible throughout the study depending on your ability to maintain the following: diet, medications, supplements, exercise, and sleep and avoid taking new supplements during the study period
- Provided voluntary, written, informed consent to participate in the study
- Healthy as determined by medical history and laboratory results as assessed by QI
Exclusion
- Women who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
- History of diagnosed chronic or major depression as assessed by the QI
- Participants undergoing behavioural therapy for depression. Participants who have completed at least 8 sessions of behavioural therapy with no improvement will be considered by the QI
- Suicidal ideation as assessed by the BDI-II
- History of psychiatric disorders such as organic brain disorders, bipolar affective disorder, personality disorder, as assessed by the QI
- Diagnosed insomnia or other sleep disorders as assessed by the QI
- Current employment that calls for shift work or have worked shift work in the last 3 weeks
- Travel across 1 or more-time zones in the last 2 weeks and/or is anticipating more travel
- Current use of prescribed medications, over-the-counter (OTC) medications, or supplements taken for treatment of depression or used to help sleep
- Current use of prescribed medications that interact with Hypericum perforatum
- Unstable metabolic disease or chronic diseases as assessed by the QI
- Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
- Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- Individuals with an autoimmune disease or are immune compromised as assessed by the QI
- Use of medical cannabinoid products
- Current chronic use of cannabinoid products (\>8 times/month) and is unwilling to stop for the duration of the study beginning 1 week prior to baseline. History of chronic and occasional use and the purpose of use to be assessed by QI on a case-by-case basis
- Alcohol intake \>2 standard drinks per day as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Participation in other clinical research studies 30 days prior to enrollment will be assessed on a case-by-case basis by the QI
- Individuals who are unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05318456
Start Date
March 24 2022
End Date
March 20 2023
Last Update
March 22 2023
Active Locations (1)
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1
KGK Science Inc.
London, Ontario, Canada, N6A5R8