Phase 2 Depression and Anxiety Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been diagnosed with major depressive disorder (MDD) without any history of psychosis, confirmed by a structured interview
• Your depression symptom score on a standard questionnaire (PHQ-9) is 10 or higher, indicating at least moderate depression
• A blood test shows your C-Reactive Protein (a marker of inflammation) is above 1
• You are between 18 and 65 years old
• You are able to understand and sign a written consent form
• Your Body Mass Index (BMI) is between 19 and 38
• You are in generally stable physical health based on blood tests, medical history, and vital signs
• You do not plan to become pregnant during the study
• If you are a woman who could become pregnant, you have a negative pregnancy blood test at the start of the study
• You agree that if something unexpected is found during brain scans (such as an abnormality), it will be reported to you

Who may not be able to join:

• You currently have or recently had serious thoughts of suicide
• You have had a moderate or severe problem with alcohol or drug use (other than nicotine or caffeine) in the past 12 months
• You test positive for alcohol or certain drugs (including opiates, cocaine, cannabis, amphetamines, ecstasy, or methadone)
• You currently have a diagnosis of a psychotic disorder (e.g. schizophrenia), bipolar disorder, an eating disorder (e.g. anorexia or bulimia), a learning disability, or a personality disorder that could make it hard to follow the study rules
• Your medication doses or how often you take them have changed in the last 6 weeks, or you plan to change them during the study (unless your doctor directs otherwise)
• You plan to take vitamins or mineral supplements during the study
• You are unable to have MRI scans
• You are pregnant or currently breastfeeding
• You plan to try to conceive during the study or within 3 months after finishing the supplement
• You have taken part in another clinical trial drug or device study in the last 60 days, participated in 2 or more clinical studies in the past year, or are currently in another interventional study
• You have had major surgery requiring general anaesthetic within the past 12 weeks, or have surgery planned during the study period
• You currently take Omega-3 fatty acid supplements (such as fish oil, DHA, or EPA)
• You have significant memory or thinking problems, or a serious ongoing condition affecting the liver, kidneys, heart, lungs, blood vessels, brain, thyroid, or metabolism
• You have a known metabolic disorder, such as Type 1 or Type 2 diabetes, fatty acid oxidation disorders, or other related conditions (confirm with trial site)
• You have an allergy to Stevia sweetener, malic acid, or orange flavoring
• There are concerns that you may have difficulty sticking to the supplement schedule
• You are currently following a ketogenic or paleo diet, or plan to during the study
• Your body weight has changed by more than 5 kg (about 11 lbs) in the month before the study starts
• You have any medical, psychiatric, or other condition that would make it hard to understand study information, give consent, follow the study rules, or complete the study
• You have metal implants (e.g. metal clips in the brain), an electronic device such as a pacemaker, or you have claustrophobia that would prevent you from having an MRI scan

Important: Always verify eligibility with the trial site directly before applying.