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:

• People who are willing to take part voluntarily and sign a consent form
• Men or women aged between 18 and 65 years (inclusive) at the time of signing the consent form
• People whose depression symptoms score at least 18 on a standard depression rating scale (called the HAMD-17) during the screening and check-in periods
• People who have been diagnosed with a depressive disorder according to the DSM-5 (the standard medical guide for mental health conditions), without any psychosis (such as hallucinations or delusions)
• People whose overall illness severity is rated at least 4 on a standard clinical scale (called the CGI-S) during the screening and check-in periods
• People who are willing to stop taking other psychiatric medications (such as other antidepressants, anti-anxiety medicines, antipsychotics, mood stabilisers, and sleeping tablets) during the treatment period, except those specifically allowed by the study
• People who are capable of having children (including male participants' partners) who have no plans to become pregnant or donate sperm from the screening period until 6 months after the last dose, and who are willing to use at least one reliable method of contraception during that time

Who may not be able to join:

• People who have a medical condition that could interfere with their participation, including a history of cancer, epilepsy, a type of anaemia where red blood cells are destroyed, a blood clot in the lungs, or serious breathing problems
• People who, in the 6 months before screening, experienced severe heart failure, unstable chest pain, a heart attack, a bleed in the brain, a stroke or mini-stroke, or had heart surgery (such as bypass surgery, a heart procedure through the blood vessels, or heart valve repair or replacement), or who the study doctor finds to have a serious irregular heartbeat at screening
• People with a personal or family history of a heart rhythm condition called long QT syndrome, a family history of sudden death in a parent, child, or sibling before age 40, a personal history of unexplained blackouts (fainting) in the past year, or an abnormal heart rhythm measurement on an ECG at screening (above specific thresholds depending on sex)
• People who have uncontrolled high blood pressure at screening (blood pressure at or above 160/100 mmHg)
• People who have significant liver problems, shown by certain blood test results being more than twice the normal upper limit
• People who have significant kidney problems, based on kidney function being below a certain level on a blood test
• People who have a history of any other mental health condition besides depressive disorder (as defined by DSM-5), including but not limited to bipolar disorder, OCD, PTSD, schizophrenia, anxiety disorders, sleep disorders, or substance use disorders
• People whose HAMD-17 depression score at the baseline visit has dropped by 25% or more compared to their score at the screening visit
• People considered at risk of suicide, including those who have made a suicide attempt in the past year, those who score 3 or above on the suicide item of the HAMD-17 scale at screening or baseline, those who answer "yes" to certain questions about suicidal thoughts on a standard safety scale (C-SSRS), or those who have had thoughts of suicide or self-harm during their current depressive episode
• People who have previously tried two or more adequate courses of antidepressant treatment without improvement
• People who are currently receiving certain talking therapies (such as cognitive behavioural therapy, interpersonal therapy, or psychodynamic therapy), music therapy, exercise therapy, acupuncture, or similar treatments and plan to continue them during the study
• People who have received brain stimulation treatments (such as electroconvulsive therapy, transcranial magnetic stimulation, or deep brain stimulation) within the 3 months before screening, or who the study doctor believes currently need such treatment
• People who stopped taking psychiatric medications less than a certain amount of time before joining the trial (the required gap depends on the specific medication — at least 2 weeks for a type called MAOIs and at least 4 weeks for fluoxetine)
• People who have a history of serious allergies, or who are known to be allergic or sensitive to any ingredient in the study drug
• People who have consumed alcohol heavily (14 or more units per week on average) or who have been dependent on alcohol in the 6 months before screening, where the study doctor believes this could affect their ability to complete the trial
• People who have had a history of drug dependence or drug misuse in the past year
• People who have a history of hepatitis B, or who test positive at screening for hepatitis B surface antigen, hepatitis C antibodies, HIV antibodies, or syphilis antibodies
• People who have taken part in another clinical trial involving an experimental drug, device, or surgical procedure within 3 months or 5 half-lives of the experimental drug (whichever is longer) before screening
• Women who test positive for pregnancy at screening or baseline, women who are pregnant, breastfeeding, or planning to become pregnant during the trial, or men or women of childbearing potential who are unwilling to use effective contraception for 6 months after the last dose
• People who are unable to swallow tablets or capsules, or who have a condition that may significantly affect how the body processes medication (such as active bowel disease, bowel obstruction, or chronic diarrhoea), or any other condition that the study doctor believes could put the person at risk
• People who have had an organ transplant (not including corneal transplants)
• People who donated blood, lost 400 mL or more of blood, or received a blood transfusion within the 3 months before screening
• People who the study doctor believes are unlikely to follow the study requirements, or who have any other reason that makes participation unsuitable

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