A Randomized, Triple-blind, Placebo-controlled, Parallel Clinical Trial to Investigate 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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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 will be assessed by the Beck Depression Inventory (BDI-II) and Profile of Mood States (POMS) Questionnaire. POMS is a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Self-reported sleep efficiency, perceived sleep debt, and sleep difficulty will be assessed by a Sleep Quality Questionnaire and supported by sleep scoring from actigraphy readings. As vitality is related to both mood and sleep, the Vitality and Quality of Life questionnaire will be used to measure changes in energy levels and quality of life over the 42-day study period. The effects of MoodElite T-4003-1 will be compared to a placebo and comparator product, EasyMind T-4008-1. EasyMind T-4008-1 contains extracts from Paeonia lactiflora, Gardenia jasminoides, Albizia julibrissin, Paeonia suffruticosa and has been shown to reduce anxiety-like behaviour in a rodent model using chronic restraint stress through reduction of corticosterone (cortisol) (unpublished results).
For the study population, the eligibility criteria limits the presence of confounding variables that could influence study outcomes. Participants will be healthy men and women between 18 and 65 years of age. Individuals will be recruited based on having mild to moderate depressive symptoms, as assessed by the BDI-II. The BDI-II contains 21 items and evaluates both psychological and physical symptoms related to depression. Participants with diagnosed chronic or major depression or psychiatric disorders will be excluded to ensure only those with mild, non-pathological depressive symptoms are enrolled. Any participants taking prescribed or over the counter mood altering medications will be excluded, as not to interfere with the evaluation of the effects of MoodElite T-4003-1 on mood. Participants taking supplements for mood support at a stable dose for at least three months will be evaluated by the QI to determine eligibility. Shift workers or individuals who have recently travelled across one or more time zones will be excluded to limit any confounding effects on outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 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
排除标准
- •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
结局指标
主要结局
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
时间窗: Days 0, 42 and day 56 (follow-up)
The change in mood between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Beck Depression Inventory-II (BDI-II). The BDI-II contains 21 items on a 4-point scale from 0 'Symptom Absent' to 3 'Severe Symptom'. Scoring is achieved by adding the highest ratings for all 21 items with a minimum score of 0 and maximum score of 63. A higher total BDI-II score indicates greater symptom severity.
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
时间窗: Days 0, 42 and day 56 (follow-up)
The change in total mood disturbance between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.
次要结局
- Change in tension-anxiety between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS(Days 0, 42 and day 56 (follow-up))
- 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(Days 0, 42 and day 56 (follow-up))
- Change in perceived sleep difficulty between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by the Sleep Quality Questionnaire.(Days 0 and 42)
- Change in depression between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS(Days 0, 42 and day 56 (follow-up))
- Change in vigor between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS(Days 0, 42 and day 56 (follow-up))
- Change in perceived sleep debt between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by the Sleep Quality Questionnaire(Days 0 and 42)
- Change in fatigue between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS(Days 0, 42 and day 56 (follow-up))
- Change in objective sleep measures between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by actigraphy readings(Days 0 and 42)
- Change in blood melatonin levels between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation(Days 0 and 42)
- Change in fecal microbiome between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation(Days 0 and 42)
- Change in confusion between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS(Days 0, 42 and day 56 (follow-up))
- Change in subjective sleep efficiency between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by the Sleep Quality Questionnaire(Days 0 and 42)
- Change in vitality throughout the day between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by Vitality and Quality of Life Questionnaire(Days 0 and 42)