The Safety and Efficacy of MoodElite T-4003-1 on Improving Mood in a Healthy Adult Population Wit… (NCT05318456) | Clinical Trial Compass
CompletedPhase 1/2
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
Canada44 participantsStarted 2022-03-24
Plain-language 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 therapeutic intervention.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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
✓. 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 criteria
✕. 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
✕
What they're measuring
1
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
Timeframe: Days 0, 42 and day 56 (follow-up)
2
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
. 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