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 are between 25 and 50 years old
• You can read and understand English and are willing to agree to the study rules and procedures
• You are willing to receive an intravenous (IV) drip and have blood taken
• A blood test shows that your C-reactive protein (a marker of inflammation in the body) is at a certain level or higher (confirm with trial site)
• You have been diagnosed with Major Depressive Disorder (clinical depression)
• Your depression symptoms are at least moderate in severity, based on a specific rating scale score (confirm with trial site)
• You have either been off antidepressant medications for at least 4 weeks before joining, or have been on a stable, unchanged antidepressant dose for at least 4 weeks — and you are willing to keep your treatment the same until the study ends
• You are willing not to start or change any talking therapies until the study ends (no more than three weeks after your screening appointment)
• You are not able to become pregnant, or if you could become pregnant, you meet specific pregnancy prevention requirements including a negative pregnancy test and/or use of an approved form of contraception (confirm with trial site for full details)

Who may not be able to join:

• You have had a recent injury or infection within the past week, or an infection in the past month that needed antibiotic or antiviral treatment
• You have a long-term infection such as hepatitis B, hepatitis C, or HIV, or you have had COVID-19 in the past 6 months or still have ongoing symptoms from it
• You have a hidden (latent) infection such as tuberculosis or fungal infections, or you have a history of repeated infections
• You have an uncontrolled heart, hormone, blood, liver, kidney, or neurological condition
• You have a history of cancer
• You have an autoimmune condition, or a neurological condition that significantly affects your thinking and memory (such as a history of stroke)
• You are currently taking certain antipsychotic or anti-seizure medications that could interact with the study drug (confirm with trial site)
• You have previously used a type of medication called a TNF antagonist, or have used steroid tablets or certain other immune-suppressing medicines within the past year
• You have a history of liver problems
• You have significant difficulties with memory or thinking, as judged by the study team
• You have an active eating disorder or obsessive-compulsive disorder that the study team believes is the main cause of your depression
• You have a history of a psychotic disorder or Bipolar disorder (type I or II)
• You have had a substance use disorder (such as alcohol or drug misuse) of more than mild severity in the past six months
• You have current thoughts of suicide at a certain level of severity, based on a specific rating scale (confirm with trial site)
• You have had electroconvulsive therapy (ECT) or deep brain stimulation (DBS) in the past year, or you still have lasting memory or thinking problems from these treatments
• You have received a solid organ transplant (such as a kidney or heart transplant)
• You regularly take certain medications that affect the immune system or thinking, including higher doses of certain sedative medicines, anti-inflammatory painkillers (such as ibuprofen), steroid-containing medicines, statins, or certain other anti-inflammatory drugs (confirm with trial site for specific details)
• The study team has safety concerns about your participation, or believes you are unlikely to complete the study
• You have previously had an allergic reaction to products derived from mice (confirm with trial site)

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