Evaluate the Effects of Citicoline on Mood in Healthy Adults

Launched by KIRIN HOLDINGS COMPANY, LIMITED · Jul 21, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether a supplement called citicoline can help improve mood in healthy adults. The study will compare the effects of citicoline to a placebo, which is a “dummy” pill that doesn’t contain the active ingredient. The goal is to see if citicoline has any positive impact on mood in people who are generally healthy but experiencing moderate mood changes.

To join the study, participants need to be between 21 and 65 years old, in good overall health, and have a body weight of at least 110 pounds. They should have moderate mood symptoms but not severe depression, and normal blood pressure and heart rate. People who smoke, have certain medical conditions, take mood-related medications or supplements, or have irregular sleep patterns won’t be eligible. Participants will be asked to keep their usual diet, exercise, and caffeine habits during the study, but must follow specific guidelines before each visit, like fasting and avoiding caffeine and alcohol for a short time. This careful approach helps the researchers understand how citicoline might affect mood without other factors getting in the way.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Provide voluntary signed and dated informed consent.
• • Be in good health and able to participate as determined by medical history and routine blood chemistries.
• • Biological men and women between 21 and 65 years of age (inclusive).
• • Body Mass Index of 18.5-32.0 (inclusive).
• • Body weight of at least 110 pounds.
• • Participant is experiencing moderate levels of mood disturbance during screening.
• • Normotensive (seated, resting systolic blood pressure \<140 mm Hg and diastolic blood pressure \< 90 mm Hg.
• • Normal supine, resting heart rate (\<90 per minute).
• • Agrees to maintain their existing dietary and physical activity patterns throughout the study period.
• • Participants agree to maintain their usual caffeine consumption habits, given that they do not exceed the maximum intake per day (400mg/day or 3-4 cups of coffee per day).
• • If a dietary supplement was initiated within the past month, the participant is willing to discontinue supplement use followed by a 2-week washout prior to participation in the study.
• • Willing to duplicate their previous 24-hour diet, refrain from caffeine for 24 hours, refrain from alcohol and exercise for 24 hours prior to each trial, and fast for 10 hours prior to each visit.
• Exclusion Criteria:
• • QIDS (Quick Inventory of Depressive Symptomology) score \> 16.
• • Women who are pregnant, lactating, or planning to become pregnant during the study. Women must have a negative pregnancy test at screening.
• • Women with a PSST (Premenstrual Symptoms Screening Tool) score ≥30
• • Current smokers or cessation within 3 months prior to screening.
• • Alcohol consumption (\>2 standard alcoholic drinks/day or \>10 drinks/week) or drug abuse/dependence.
• • Current use of any nootropic dietary supplements (e.g., GABA, Ashwaghanda, St. John's Wort, Ginkgo biloba, L-theanine, choline, Lion's mane, creatine, etc.) or medications (e.g., piracetam, Adderall, modafinil, etc.) that may confound the study or its endpoints.
• • Medical history of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
• • Individuals who have been diagnosed with digestive, liver, renal, cardiovascular, or other metabolic diseases.
• • Other known gastrointestinal or metabolic diseases that might impact nutrient absorption, distribution, metabolism, or excretion (e.g., intestinal malabsorption, electrolyte abnormalities, diabetes, thyroid disease, adrenal disease, hypogonadism, short bowel syndrome, diarrheal illnesses, history of colon resection, gastric ulcer, reflux disease, gastroparesis, Inborn-Errors-of-Metabolism, etc.).
• • Chronic medically diagnosed inflammatory condition or disease (e.g., rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
• • Medical history of a cognitive (i.e., ADD/ADHD) or psychiatric disorder, or brain-related medical conditions (e.g., TBI, ADHD).
• • Currently using medications to treat anxiety or depression.
• • Have an irregular sleep pattern (i.e. shift workers) or inadequate sleep schedule (i.e., less than 6 hours per night).
• • Known sensitivity, allergy, or intolerability to any ingredient in the test products.
• • Participants who report a clinically significant illness within the last 30 days.
• • Individuals who are cognitively impaired and/or who are unable to give informed consent.
• • Any other diseases or conditions that, in the opinion of the Principal Investigator, could confound the primary endpoint or place the subject at increased risk of harm if they were to participate.